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ACKNOWLEDGMENTS | Not applicable. | PMC10469752 | ||
DATA AVAILABILITY STATEMENT | All data, models, and code generated or used during the study appear in the submitted article. | PMC10469752 | ||
REFERENCES | PMC10469752 | |||
Background | COPD | COPD | Pulmonary rehabilitation (PR) decreases rehospitalization for people with COPD. However, less than 2% receive PR, partly due to lack of referral and sparsity of PR facilities. This disparity is particularly pronounced in African American and Hispanic persons with COPD. Telehealth-provided PR could increase access and improve health outcomes. | PMC10202528 |
Methods | We applied the RE-AIM framework in a | PMC10202528 | ||
Results | fatigue | Two hundred nine people enrolled out of a 276-recruitment goal. Only 85 completed at least one PR session 57/111 (51%) TelePR; 28/98 (28%) SPR. Referral to TelePR compared to SPR did not decrease the composite outcome of 6-month COPD-readmission rate/death (OR1.35;95%CI 0.69,2.66). There was significant reduction in fatigue (PROMIS® scale) from baseline to 8-weeks in TelePR compared to SPR (MD-1.34; ± SD4.22; | PMC10202528 | |
Conclusions | comorbidity, COPD | COPD, RECRUITMENT | TelePR can reach COPD patients with health disparities and can be successfully implemented. The small sample size and large confidence intervals prevent conclusion about the relative effectiveness of participating in TelePR compared to SPR. However, improved outcomes were seen for those in TelePR as well as in SPR. Increasing adoption of PR and TelePR requires consideration of comorbidity burden, and perception of PR utility, and must facilitate medical clearances. Given the sparsity of SPR locations, TelePR can overcome at least the barrier of access. However, given the challenges to the uptake and completion of PR - many of the additional barriers in PR (both in TelePR and SPR) need to be addressed. Awareness of these real-world challenges will not only inform implementation of TelePR for clinicians seeking to adopt this platform but will also inform study designers and reviewers regarding the feasibility of approaches to patient recruitment and retention. | PMC10202528 |
Supplementary Information | The online version contains supplementary material available at 10.1186/s12913-023-09492-7. | PMC10202528 | ||
Keywords | PMC10202528 | |||
Contribution to the literature | comorbidity, comorbid disease |
Given the sparsity of physical PR locations, telehealth-delivered PR can overcome some barriers to access such as transportation and patient level mobilityAlthough facilitating access to PR allowed us to control for common socioeconomic factors that typically prevent populations experiencing health/health care disparities from completing PR, decision-making about adherence was motivated by patients’ weighing their immediate short-term circumstances, comorbid disease demands, and nonbiomedical knowledge.To promote uptake, pulmonary rehabilitation referrals must include considerations of comorbidity burden, the perception of PR utility, and must facilitate medical clearances. | PMC10202528 | |
Introduction | depression, COPD | COPD, RECRUITMENT, CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Chronic Obstructive Pulmonary Disease (COPD) is the leading cause of hospitalization for older adults in the United States, and accounts for 1.5 million emergency department visits per year [We hypothesized that referral to a telehealth-delivered PR program (TelePR) would overcome access barriers to PR, which in turn would increase adherence, with subsequent improvement in health outcomes. As with access to other forms of health care, people with health disparities also have barriers to accessing PR which include socioeconomic factors such as insurance coverage and transportation costs, disruption to established routines, travel and location of PR, lack of perceived benefit, depression and poor state of health, and inconvenient PR schedule times [Despite iterative and user-centered design, and despite the iterative feedback of a stakeholder-based community advisory board, the study was limited by difficulties in recruitment and retention of the target population. To evaluate our TelePR program to inform future study designs and the implementation of TelePR, we applied The RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework. This systematic framework has been successfully used to evaluate the implementation of healthcare interventions [ | PMC10202528 |
Methods | PMC10202528 | |||
Trial overview | death, COPD | COPD, SECONDARY | This was a two-arm, mixed method, single-blinded superiority randomized controlled comparative effectiveness trial where we collected 12-month longitudinal data. The hypothesis was that a referral to TelePR would lead to lower 6-month rehospitalization, or death compared to a referral to standard, office-based pulmonary rehabilitation (SPR). The secondary outcomes included changes from baseline to post-PR sessions (i.e., day 1 and 8-weeks) and tertiary outcomes included update and adherence to PR after referral, longitudinal changes (6- and 12-months) in symptoms and whether patients would continue to exercise. Figure SOutcomes were chosen based on the known effect of PR in COPD persons, and clinical relevance to patients and providers. Where available, we selected measures validated for use in both English/Spanish. | PMC10202528 |
Participants | COPD | COPD, COPD EXACERBATION | Participants included African American or Hispanic persons who were hospitalized for a COPD exacerbation at one of 9 hospitals in the New York City metropolitan area. Eligibility criteria included: COPD diagnosis, Hispanic or African American ethnicity/race, and current hospitalization for COPD-exacerbation. Potential participants were identified via the electronic medical record. | PMC10202528 |
Consent process | COPD | COPD, RECRUITMENT | Participants were invited to enroll in a program to assist with management of their COPD, a referral to SPR and survey follow-up over the course of 1 year. Participants were shown an English/Spanish testimonial video depicting SPR or TelePR during recruitment. If they agreed, they signed consent form 1 which allowed for prospective collection of data over the course of 1 year from the EMR and via phone call, as well as a referral to PR. Participants were then randomized to receive the PR component of the program via either (1) a referral to SPR or (2) a referral to TelePR. As per the modified Zelen Randomized Consent Form (MZRCF) method [The MZRCF method allows researchers to obtain consent from patient participants for longitudinal follow-up in standard of care and then to randomly assign study participants to either the intervention (TelePR) or the control arm (SPR), for which additional informed consent must be obtained for those enrolled in the technology-based arm (i.e., nonstandard arm, consent form 2). We predicted that if a study participant was randomly assigned in a conventional way and did not receive the “high-tech” TelePR intervention, it was likely that they would refuse to continue in the study.After enrollment, participants needed to receive medical clearance to be able to participate in PR. This required confirmation of COPD by a pulmonary function test (PFT) or a pulmonologist’s clinical diagnosis and a medical provider’s determination that the patient could exercise safety. These determinations required an in-person visit to the patient’s pulmonologist and, for those with cardiac medical comorbidities, an additional visit to a cardiologist for medical clearance. | PMC10202528 |
Randomization | Randomization was carried out in permuted blocks and stratified by enrollment site and by race/ethnicity. Both the biostatistician performing outcomes analyses, and the clinicians who were providing medical clearance were blinded to study allocation/randomization. | PMC10202528 | ||
Intervention- TelePR | Participants in the TelePR arm had PR delivered via telehealth in either the participant’s home or community center (if preferred and depending on space in their homes). All the equipment including a full-size recumbent bicycle, weights, stretch bands, vital sign monitor and tablet computer with Wi-Fi card was delivered to patient homes. Prior to the first session, the RT met participants in their home/community center for training on device usage and to check oxygen supplementation devices. TelePR sessions were conducted by the RT with up to 3-participants simultaneously, via a secure HIPAA-compliant server using Zoom web-conferencing technology (Fig. SAfter completion of 8-weeks of PR, all equipment was recovered from the TelePR participants. Both the TelePR and SPR participants were provided with an exercise-peddler and a list of community centers, gyms, and different SPR locations to encourage continuation of exercise. | PMC10202528 | ||
Active control- standard pulmonary rehabilitation | For those enrolled in the SPR arm, two SPR sites were made available to participants within the study geographic area: Northwell Health Physician Partners Pulmonary and Sleep Medicine at Lake Success, New York and Glen Cove Hospital Outpatient Pulmonary Rehabilitation Program, Glen Cove, New York. We recruited patients within the metropolitan New York area – depending on where the patients lived – these centers were either within a 20 min or 1 h commute for patients. SPR facilities are equipped with exercise equipment, vital sign monitors, and supplemental oxygen devices, and are staffed by a team of RTs, other clinicians, and administrators. Educational lectures are given as part of the PR sessions.Participants in both arms received $175 for their time completing longitudinal surveys. TelePR was provided at no cost to the participant. However, participants in SPR were required to pay co-payments based on insurance laws and SPR was charged to participants’ health insurance.TelePR was provided at no cost to the patient; however, SPR was charged to participants’ health insurance, and co-payments were required. Both arms needed to have medical clearance appointments submitted to their insurance carriers and to pay co-payments when applicable. During the initial consent (consent form 1), all participants were made aware of this real-world requirement for SPR. It was not until the participant was randomly assigned to TelePR that the research team explained that the intervention could not be paid for by insurance and therefore would be paid by the study grant. Before the start of the program, the social worker and research team had discussed sliding-scale payment options with the health system and worked closely with the medical billing departments to assist with insurance navigation for participants.Transportation costs were covered to and from clinic visits for medical clearance appointments and the SPR sessions. When possible, the social worker attempted to leverage existing insurance-subsidized transportation programs to offset the cost to the patient. | PMC10202528 | ||
Exercise training content and progression for SPR and TelePR | Each PR session was approximately 60-min, consisting of 30-min of aerobic exercise on a treadmill (SPR) or bicycle (TelePR), 20-min of anaerobic exercise and 10-min of cool down. The bilingual respiratory therapist (RT) developed an individualized exercise program for each participant based on exercise capacity, and documented progress using standardized forms paralleling those used in SPR.A bilingual social-worker maintained contact with each participant from the time of hospital discharge to completion of the PR program to assist with identifying insurance-subsidized transportation programs, insurance navigation for participants without insurance, and arranging clinic appointments. | PMC10202528 | ||
Outcome measures | The RCT outcome measures are presented within the RE-AIM (Table RE-AIM applied in context of TelePR vs SPR study | PMC10202528 | ||
Reach | RECRUITMENT | The Reach of an intervention measures whether the intended/target population was reached by the program, and whether the intended population expressed interest in participating in the program. This is outlined in the CONSORT diagram. To increase the likelihood that our intervention would appeal to our target population, we convened a study-specific Community Advisory Board (CAB) comprised of patients and caregiver’s representative of our target communities, directors of PR clinics, and clinicians. The CAB provided input on initial study protocols, modifications to increase recruitment and retention, and the acceptability of the equipment that was used in TelePR including testing the bikes and technologies associated. Additionally, as part of the clinical trial, we conducted interviews and focus groups with participants who had different levels of adherence to PR to identify and address barriers they encountered. | PMC10202528 | |
Effectiveness | PMC10202528 | |||
Primary outcome | Our primary outcome was a composite of COPD-related hospital readmissions/death within 6-months of discharge, based on the mean duration of 6-month follow-up in the systematic review used for sample-size calculation [ | PMC10202528 | ||
Secondary outcomes | SECONDARY | Our secondary outcomes included changes from baseline to post-PR sessions (i.e., day 1 and 8-weeks) in: perceived symptom control and Quality of Life (QOL) (CAT, MMRC) [ | PMC10202528 | |
Tertiary outcomes | We further assessed differences in uptake (participating in at least one PR session, which is described as ‘adoption’ in RE-AIM) and adherence (completion of the program and number of sessions attended of the 16-total PR sessions). In addition, we measured CAT, MMRC, PROMIS, and whether participants continued with exercise (yes/no self-report) at 6- and 12-months, and feasibility of equipment delivery and function in TelePR. We also recorded technical or other barriers to TelePR session completion, and participant satisfaction with the program (Table S | PMC10202528 | ||
Sample-size and power calculation | COPD | COPD | The 276-person sample-size was based on an effect size of 0.3 odds ratio (OR), with 20% loss to follow-up and 80% power to detect superiority of referral to TelePR compared to SPR for the 6-month COPD readmission/mortality outcome using a two-sided chi-squared test at a significance level of 0.05 [ | PMC10202528 |
Quantitative analysis | COPD | REGRESSION, COPD | There were three levels of analysis: Intention to Treat (ITT), which included all the people randomized at the beginning of the study (excluding those who were later found to not met inclusion criteria for referral, such as immobility after hospital discharge or PFT results that did not indicate COPD) (ITT); people randomly assigned to a study arm and medically cleared (Sub-analysis 1), and people who were randomly assigned, medically cleared, and who had participated in at least 1 PR session (Sub-analysis 2).The ITT analysis compared outcomes for those randomized to TelePR vs. SPR, excluding those who would not have received a referral to PR in real-world practice (i.e., those who were later found not to meet inclusion criteria because they were immobile or did not have COPD, or who became medically unstable). We then performed 2 sub analyses: Sub-analysis 1 for patients who ultimately received medical clearances after referral (i.e., patients who would be allowed to Logistic regression analysis compared the odds ratio of the primary outcome, in 3 sets of models: Continuous variables were summarized using mean, median and standard deviation; categorical variables were summarized using frequency and percentages. Two-sample t-test or nonparametric Wilcoxon test compared the continuous variables, and Chi-squared test or Fisher’s exact test compared categorical variables. To compare continuous variables between day 1 and 8-weeks, we used a paired t-test or nonparametric signed rank test, and a generalized linear mixed models (repeated measures analysis of variance “MMRMA”) to determine whether there was a difference in the change over time between the arms, and if the magnitude of change depended on treatment arm (treatment x time interaction). Unstructured covariance was used in all the models. Adherence was separately included as a covariable to examine its role on the primary outcome in the models. | PMC10202528 |
Missing data | APPENDIX | Missing data was handled using multiple imputation with details described in Appendix S | PMC10202528 | |
Qualitative methods and analysis | APPENDIX | Qualitative interviews and focus groups conducted among a sample of participants allowed for a deeper understanding of (1) the barriers to initiating PR despite a referral to PR and (2) the barriers to participating in > 1 PR session once started (Appendix S | PMC10202528 | |
Adoption | COPD | COPD, RECRUITMENT | Adoption measures the proportion of people/settings who were willing to initiate the intervention. Because the intervention was in participants’ homes, the proportion of people who initiated TelePR sessions in their homes is the relevant metric for adoption and for describing barriers to adoption. In addition, we report the proportion of community centers that were willing to ‘house’ the TelePR sessions for participants who did not have space for equipment in their homes.To increase adoption, we held meetings twice a year (estimated 10 meetings) with local clinicians informing them about the TelePR program - within the context of the clinical trial - including an email communication across the entire Northwell Health System by the chair of medicine, and presentations at division meetings. We worked with our CAB to identify methods to increase referral by hospital staff (physicians and respiratory therapists) for potentially eligible patients, and to increase adoption by the COPD patients and their families once approached by the study team. These meetings informed our recruitment materials targeted specifically to people from predominantly underserved Hispanic and African American people with COPD in the NYC metropolitan region. Details are provided in a separate manuscript [ | PMC10202528 |
Implementation | Implementation measures whether the intervention was delivered as intended. We include measurements of fidelity to clinical trial protocols, describing in detail any adaptations that were made based on CAB feedback as well as due to early findings in the clinical trial execution. We also report fidelity to the TelePR intervention components, to address specific factors relevant to TelePR sessions being executed as intended.Our CAB provided recommendations for successful implementation of TelePR. This included improvements to equipment functionality, safety features for frail, older patients using the ergonomic stationary bike, providing a micro-key to the telehealth tablet computer to make it easier for older patients to turn it on and off and to access the features needed; and a laminated how-to sheet attached to the equipment. To increase retention among those patients who were enrolled in the program, we distributed a monthly newsletter, and a dedicated social worker helped participants obtain medical clearance appointments and associated considerations if they were re-hospitalized during the program. | PMC10202528 | ||
Maintenance | Maintenance measures the continued use of the program over time. For this study, because it was funded by clinical trial grant monies, we measured maintenance on two levels. First, individual level maintenance of exercise by joining a gym or by continuing in a standard PR program. This does not reflect the value of TelePR directly but measures motivation that TelePR provided to exercise and the benefits of exercise. Second, we describe inquiries from health systems and pulmonary organizations to continue the TelePR programs, and the logistical and financial considerations that were discussed. | PMC10202528 | ||
Trial registration | The study was registered with the National Institutes of Health clinical trials registry. Study was registered on 02/01/2017 and registration number is NCT03007485. The trial registration website is | PMC10202528 | ||
Results | PMC10202528 | |||
Reach | RECRUITMENT, RECRUITMENT | Recruitment occurred from April 2017 to June 2019. The trial was successful in recruiting from the intended patient population as outlined in Table Demographics for those who were medically cleared and participants who participated in PR sessions51 (27)median: 4748 (19)median: 465.03 (2.29)median: 5.005.03 (2.41)median: 5.004.94 (2.44)median: 4.505.17 (2.58)median: 5.005.19 (2.60)median: 5.005.05 (2.59)median: 5.00Consort Diagram – monitor and record participant recruitment, exclusion, and dropout. Abbreviations: AA, African American; ITT1, intention to treat included people randomized at the beginning of the study who met inclusion criteria; PFT, pulmonary function test; Rehab, rehabilitation; PR, pulmonary rehabilitation; SPR, standard pulmonary rehabilitation; TelePR, telehealth-delivered pulmonary rehabilitation. *At the start of the study those who failed the mini-cog survey were excluded, however, that survey was removed from the study. **Agreed to start and received surveys. Some people chose to just be followed over time | PMC10202528 | |
Effectiveness | PMC10202528 | |||
Tertiary outcomes | Most patients who started PR completed the program, with 47 of 57 (82%) participants in TelePR, and 20 of 28 (71%) participants in SPR completing the program. The mean number of PR sessions attended out of the 16-total was similar in both arms (TelePR 59.21% (± SD 27.85), median 68.75%; and SPR 62.95% (± SD 35.76), median: 71.88%). | PMC10202528 | ||
Longitudinal changes over one-year follow-up | SECONDARY | Improvements seen from baseline to 8-weeks (i.e., from before to after completing the 8-week PR program) did not persist at 12-months of follow-up. All secondary outcomes (i.e., CAT, MMRC, and PROMIS) regressed to baseline scores. For example, at baseline, TelePR had a 22.27(8.35); 24.00 (mean (SD; median) and SPR had a 20.89(8.53); 24.00 for the CAT score. During 12-month assessment, TelePR had a 23.00(8.26); 23.00 and SPR had a 20.09(7.70); 21.500 for the CAT score -demonstrating that the scores had regressed. Very few participants (22.50% TelePR and 12.50% SPR) reported that they were continuing to exercise (Table S | PMC10202528 | |
Adoption | cancer, ill, ’ | CANCER | Of the 111 people referred to TelePR only 57 (51%) attended at least one PR session. In comparison, only 28 (28%) of the 98 referred to SPR attended at least one PR session. Therefore, although adoption was low, a higher proportion of patients were willing to initiate TelePR than SPR. There were several barriers to community settings agreeing to have the TelePR sessions conducted from their sites which included concerns about equipment theft, climate control for storage, and safety concerns in case other people used the equipment. There were also liability concerns that needed to be addressed by our legal consultants.Our qualitative interviews revealed that one important barrier to TelePR adoption was related to beliefs that PR itself was not effective because patients’ clinicians had not previously recommended it. An illustrative quote is: “… Barriers to participation in any form of PR included having to prioritize treating more pressing health concerns such as cancer or dialysis appointments. Comorbidities prevented adoption due to scheduling conflict concerns with other clinic appointments, and concern about burden to family members who would be needed for transportation and for attending sessions. In fact, once a referral was made to either TelePR or SPR, the need to attend an in-person medical clearance exam was a common barrier to completing the referral. Social constraints included caring for grandchildren and the need to have someone in the home to help them start the video sessions for TelePR. Further, some patients did not have adequate space in the home to store the equipment or did not have a permanent residence but did not want to attend sessions in community centers due to lack of transportation or feeling too ill to leave the home. | PMC10202528 |
Implementation | Overall, the TelePR program was able to be successfully implemented. | PMC10202528 | ||
Fidelity to clinical trial protocol and adaptations made | Adaptations that needed to be made to the protocol included the addition of a qualitative component to understand why we had difficulty enrolling patients. Thirty-nine qualitative interviews were conducted among participants who either did not complete the PR program ( | PMC10202528 | ||
Fidelity to components of the TelePR program | comorbidity | The TelePR program to be tested in the RCT was a new program developed by the investigators. Therefore, the equipment used required usability testing to support user-centered design before enrolling patients. We studied barriers to implementation of the intervention while the clinical trial was ongoing and made necessary adaptations to equipment and enrollment materials in real-time. These were all recorded and are reported below.Of the 52 participants who chose to receive TelePR in their own homes, 47 completed the full 8 weeks. On average participants completed a median of 11 sessions out of 16 total sessions with most sessions missed due to comorbidity related clinic visits or hospitalization (Table PR adherence for TelePR and SPR who participated in at least one PR session9.47 (4.46)median: 11.0059.21% (27.85Median: 68.75%10.07 (5.72)median: 11.5062.95% (35.76)Median: 71.88 | PMC10202528 | |
Usability testing for the TelePR platform | We performed in-lab and in-field usability testing to check interactions with the TelePR equipment and make necessary refinements [Adaptations included: having the RT review a checklist with participants (i.e., water, oxygen, if necessary, weights, band, and a phone in case of emergency), adjusting the tablet mounting on the bike, making the icons on the tablet larger, and for those patients unable to complete TelePR sessions without in-person support – having either a caregiver or study team member present during the PR session. | PMC10202528 | ||
Delivery feasibility and equipment function in TelePR | MINOR | All the bikes were able to be delivered to TelePR participants’ homes, with only minor issues that were easily addressed. Home set-ups were almost all without problem. Minor delays included: bike malfunctions, technical difficulties with the tablet computer, internet connection issues, and for those not having an AC during the summer inability to exercise. Overall, the main barriers faced during sessions were technical difficulties with the software due to internet speed, and difficulty interacting with the equipment (tablet computer, launching the software, and adjusting the bike) that were addressed in usability testing. These adaptations are reported in detail separately [The staffing necessary to execute the TelePR program included a bilingual respiratory therapist and social worker, pulmonologist, recruiters, clinical research coordinators, and a study manager. After the trial was completed, there was strong support by the department of medicine, as well as by the patients who had completed the program to continue offering TelePR. | PMC10202528 | |
Maintenance | TelePR | For our program, maintenance covers two distinct areas: 1) among the patients who completed the program, the adoption of long-term behavior changes learned though PR participation including regular exercise, and breathing techniques; and 2) among providers, the extent to which PR clinics have incorporated TelePR into their standard services for their chronic pulmonary patients in the post-study period.Only 5 of the 57 people in TelePR continued some form of exercise at 6 months after study enrollment. Several participants stated that they felt the program had been taken away from them, almost as if a ‘rug had been pulled out from beneath them’ despite efforts by the study team to inform them of local gyms for continued exercise and the delivery of the stationary peddler for continued exercise. In fact, at the end of the program and compared to the start of PR for both TelePR and SPR participants, the social isolation score worsened likely reflecting this feeling of being abandoned after such frequent contact with the PR group. Several participants stated they were continuing to engage in some form of exercise (e.g., walking). Unfortunately, for many patients who had benefitted from PR, continued access to a PR program once their time in the study had ended was not possible due to transportation and financial difficulties and long waitlists for PR.Among providers, during the COVID-9 pandemic, rapid changes in telehealth permissible platforms and insurance reimbursement structures occurred. The Pulmonary division at the largest hospital adopted the same tools that the trial used for vital sign monitoring, and the protocol for TelePR sessions, using a different web-based platform. Unfortunately, nation-wide staffing shortages of respiratory therapists prevented this program from being implemented. Very low rates of insurance reimbursement for PR and for telehealth visits are further barriers. This demonstrates that TelePR is not anymore of a barrier compared to SPR. | PMC10202528 | |
Discussion | lung disease, fatigue, ’, stage lung disease, COPD | LUNG DISEASE, ADVERSE EVENTS, DISEASE, RECRUITMENT, COPD, SECONDARY | TelePR is equivalent to SPR in terms of QOL and exercise capacity, and superior in terms of patient adherence to PR. Stickland et al. [Using the RE-AIM framework we demonstrate that TelePR was able to reach the intended population; was not comparatively superior to those referred to SPR; was effective in improving health outcomes when evaluating pre-and post- health metrics for those who completed TelePR including improved COPD knowledge and management skills, decreased fatigue and improved functional capacity; had low rates of adoption due to perceived benefit of exercise and social challenges largely related to comorbidities and needing in-person medical clearance appointments – although there was higher adoption compared to those referred to SPR; was able to be successfully implemented in patients’ homes; and had low maintenance rates after the program was discontinued. Several participants stated they were continuing to engage in some form of exercise (eg, walking) but those who were no longer engaging in physical activity cited during the interviews that a lack of access either to a PR facility or to the exercise equipment as barriers to continued physical activity.It is possible to successfully conduct TelePR sessions for people with advanced stage COPD with multiple comorbidities who were recently hospitalized, and for people who are from typically underserved Spanish-only speaking and/or Black communities. Many TelePR participants stated that watching other patients with similar health problems as themselves via teleconference motived them to push themselves to stay on the same exercise level or, at times, be better. Because of the various comorbidities that individuals with COPD face, social isolation is a common factor [We identified several barriers to adoption of TelePR by patients, the most significant of which was beliefs about the importance of exercise compared to other types of disease management such as medication. This sometimes led to deliberative and informed decisions not to take part in PR despite the support of a social worker and study team. Our recruitment videos attempted to address beliefs about exercise futility using patient-testimonials. However, effective messaging must come from multiple outlets to influence social norms about exercise in advanced stage lung disease. This includes buy-in from primary care physicians about the feasibility and safety of PR for these patients.For those who accepted a referral to TelePR, the most significant barrier to starting was the requirement for in-person medical clearance. It is possible that with the increasing prevalence of telehealth visits, preliminary clearance could be obtained before hospital discharge, with a follow up via telehealth prior to initiating the first TelePR session. Several hospitalists, primary care and even some pulmonary clinicians were reluctant to ‘clear’ patients with such advanced lung disease for exercise, fearing adverse events during exercise. The same reluctance was not encountered among cardiologists. This may be an area of necessary education regarding the relative benefit of exercise therapy and the other components of PR – education and socialization- that outweigh harms. In fact, there were no serious adverse events related to PR in our study.A particularly important lesson learned is the lack of maintenance of exercise once people completed the 8-week program and the clear necessity for maintenance PR to be available for people with advanced stage COPD to prolong the achieved health improvements. Unfortunately, improvements seen in secondary outcomes did not persist at 6 and 12 months, which was not unexpected, because few, if any, patients had access to PR beyond the research study. This is a known limitation of PR programs, wherein, due to insurance reimbursement constraints and long wait lists for new PR participants, there is a limited number of PR sessions available to patients. Although preparation to transition out of the PR program includes conversations about the importance of maintaining exercise to preserve the gains made during the program, many patients do not continue exercise, as evidenced by the follow-up phone calls. Participants frequently stated they would have liked to continue attending the PR sessions (both TelePR and SPR) but that they were unable to do so due to transportation and financial difficulties. Patients in real-world PR programs are invited to continue in a maintenance program such as once-weekly sessions; however, there are long waitlists and one main barrier to PR maintenance is that many insurance policies limit the number of PR sessions to 72 sessions within a lifetime, if they cover it at all – having people pay out of pocket. Prior studies have shown significant benefit while in a PR maintenance program for 4–5 years compared to short-term PR in individuals with COPD [In summary, while we were able to reach our intended target population and to implement a TelePR intervention that maintained high fidelity to standard PR, we faced multiple barriers to adoption and maintenance at both patient and provider levels. Therefore, we recommend increased messaging from primary care providers and community-based outlets about the benefits of PR, facilitating referrals and medical clearances for PR, supporting wide-scale TelePR availability, and supporting reimbursement for maintenance PR programs. | PMC10202528 |
Study limitations | The most important study limitation is the small sample size of 85 participants who completed the referral and attended at least one PR session in either arm of the study. This limits our ability to conclude whether participation in TelePR (as opposed to a referral to TelePR) decreases 6-month readmissions/death when compared to those participating in SPR. An additional limitation is that we applied the RE-AIM framework in a | PMC10202528 | ||
Conclusion | COPD | COPD | TelePR is safe and effective to implement among people with advanced stage COPD and comorbidities from underserved Hispanic and Black communities. Although facilitating access to PR allowed us to control for common socioeconomic factors that typically prevent populations experiencing health/health care disparities from accessing PR, beliefs about the utility and safety of exercise therapy, and the burden of competing comorbidities are barriers to adoption. Messaging to clinicians and communities about the benefits of PR and messaging to payors about potential cost-savings of subsidizing PR and PR maintenance is necessary for improved adoption and for dissemination. | PMC10202528 |
Acknowledgements | We would like to thank our patient-partners, stakeholders, study participants, physicians, and community centers for helping us throughout the study. | PMC10202528 | ||
Authors’ contributions | JP, RP | All listed authors qualify for authorship based on making one or more substantial contributions to the intellectual content; NH, JP, MB, ZM, DT, RP, SK, PM, and SJ, conceptual design, NH, JP, MB, ZM, RP, RM, MW, EBC, DR, and KO, acquisition of data, and/or analysis and JP, MB, MZ, KO, MW, RP, and NH, interpretation of data. Additionally, all authors participated in drafting the manuscript and critical revision of the manuscript for important intellectual contact. The author(s) have approved the submitted manuscript and have agreed both to be personally accountable for the author’s own contributions and to ensure that questions related to the accuracy or integrity of any part of the work, even ones in which the author was not personally involved, are appropriately investigated, resolved, and the resolution documented in the literature. | PMC10202528 | |
Funding | Research reported in this work was funded through a Patient-Centered Outcomes Research Institute® (PCORI®) Award (1511-33066). The statements presented in this work are solely the responsibility of the author(s) and do not necessarily represent the views of the Patient-Centered Outcomes Research® (PCORI®), its Board of Governors or Methodology Committee. This work was also supported by grant R24AG064191 from the National Institute on Aging of the National Institutes of Health. The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication. The views expressed in this paper are those of the authors and do not represent the views of the National Institutes of Health, the United States Department of Health and Human Services, or any other government entity. | PMC10202528 | ||
Availability of data and materials | All data generated or analyzed during this study are included in this article (and its supplementary information files). | PMC10202528 | ||
Declarations | PMC10202528 | |||
Ethics approval and consent to participate | Approval for this study was granted by Northwell Health’s Human Research Protection Office in The Feinstein Institutes for Medical Research (IRB #16-663) and by Wyckoff Height Medical Center’s Investigational Review Board (IRB #2710). All methods were carried out in accordance with relevant guidelines and regulations. Informed consent was obtained from all subjects and/or their legal guardian(s). | PMC10202528 | ||
Consent for publication | Not Applicable. | PMC10202528 | ||
Competing interests | The authors declare no competing interests. | PMC10202528 | ||
References | PMC10202528 | |||
Background | Cesarean section often requires an urgent transfusion load due to decreased blood pressure after spinal anesthesia. This prospective randomized study aimed to investigate whether a preoperative oral rehydration solution (ORS) stabilized perioperative circulatory dynamics. | PMC10466736 | ||
Methods | bleeding | BLOOD, BLEEDING | Sixty-three parturients scheduled for cesarean section under combined spinal epidural anesthesia (CSEA) were randomly allocated to one of three groups: Group O received 500 mL ORS before bedtime and 500 mL 2 h before CSEA; Group M received mineral water instead of ORS; and Group C had no fluid intake (controls). After entering the operating room, stomach size was measured using ultrasound. Blood samples were obtained, and CSEA was induced. Vasopressors were administered when systolic blood pressure was < 90 mmHg or decreased by > 20%. As a vasopressor, phenylephrine (0.1 mg) was administered at ≥ 60 beats/min heart rate or ephedrine (5 mg) at < 60 beats/min heart rate. The primary outcome was the total number of vasopressor boluses administered. Secondary outcomes were the cross-sectional area of the stomach antrum, maternal plasma glucose levels, serum sodium levels, total intravenous fluid, bleeding volume, urine volume, operative time, and cord blood gas values after delivery. | PMC10466736 |
Results | The total number of vasopressor boluses was lower in Group O than in Group C ( | PMC10466736 | ||
Conclusions | In women scheduled for cesarean section, preoperative ORS stabilized perioperative circulatory dynamics. Neither ORS nor mineral water consumption increased the stomach content volume. | PMC10466736 | ||
Trial Registration | This trial is registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN000019825: Date of registration 17/11/2015). | PMC10466736 | ||
Keywords | PMC10466736 | |||
Background | hypotension | LATE PREGNANCY, COMPLICATED PREGNANCIES, DELAYED GASTRIC EMPTYING, FETAL DISTRESS | Regional anesthesia (spinal, epidural, and combined spinal epidural [CSEA]) is the recommended standard practice for elective cesarean section because it offers a rapid onset and reliable surgical condition. In addition, it avoids the most common risks associated with general anesthesia, such as difficulty with airway management, pulmonary aspiration of gastric contents, and the negative effects of general anesthetics on the fetus. However, maternal arterial hypotension during regional anesthesia for cesarean section remains the main disadvantage, particularly for spinal anesthesia, and can result in fetal distress and maternal discomfort [Human and animal studies have found that carbohydrate loading before surgery leads to an improved response to surgical stress and postoperative conditions compared with traditional fasting guidelines. From such positive findings, PORT before elective surgeries has been recommended as an essential element of the enhanced recovery after surgery protocol. However, in general, late pregnancy causes delayed gastric emptying. The Practice Guidelines for Obstetric Anesthesia approved by the American Society of Anesthesiologists (ASA) suggests that women with uncomplicated pregnancies undergoing elective cesarean delivery should adhere to the same presurgical fasting guidelines as non-pregnant women, such as 6–8 h of no solid food and 2 h of no liquids before the scheduled surgical procedure [Our primary hypothesis with this prospective, randomized, open-label (but assessors are blinded), blinded-endpoint controlled clinical trial was to determine if preoperative intake of ORS (OS-1®) stabilized perioperative circulatory dynamics during cesarean section. We also measured stomach size using ultrasound to investigate the safety of ORS. | PMC10466736 |
Methods | PMC10466736 | |||
Ethics approval and consent to participate | CROSS | This study was approved by the Ethics Committee of Kushiro Red Cross Hospital (Hokkaido, Japan) and is registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN000019825). The trial was conducted from February 2014 to July 2017 at Kushiro Red Cross Hospital, Japan, which is affiliated with the Department of Anesthesiology and Critical Care Medicine of Asahikawa Medical University. Written informed consent was obtained from all participants at least 24 h before the operation. | PMC10466736 | |
Study participants | abnormal pregnancy, fetal anomalies | PREGNANCY-INDUCED HYPERTENSION, GESTATIONAL DIABETES, ABNORMAL PREGNANCY, PREGNANCY COMPLICATIONS, PLACENTA PREVIA, COAGULOPATHY, BLEEDING DISORDERS, COMPLICATIONS | Parturients with no complications who were scheduled for elective cesarean section were recruited for this study. The inclusion criteria were healthy parturients aged > 18 years and with ASA physical status class II with term singleton pregnancies undergoing elective cesarean section under CSEA. All parturients were scheduled to enter the operating room at 9:00 am.The exclusion criteria were emergency cesarean section, being scheduled for cesarean section under general anesthesia, multiple fetuses, abnormal pregnancy (such as placenta previa and placenta accrete), pregnancy complications (such as pregnancy-induced hypertension, gestational diabetes, bleeding disorders, and coagulopathy), fetal anomalies, and inability to undergo epidural anesthesia. In addition, failure to assess gastric measurement resulted in the exclusion of the participants from the data analysis. | PMC10466736 |
Randomization and masking | ® | Eligible parturients were randomized into one of three groups using a web-based tool (OS-1® contains water, glucose, and electrolytes and is packaged in a 500-mL plastic bottle; its composition is presented in Table
OS-1® compositionBlinding of parturients was not feasible because of the taste of the drinks; instead, well-trained anesthesiologists were made unaware of patient allocation, and other study investigators analyzed the data. | PMC10466736 | |
Gastric emptying assessment before anesthesia induction | DECUBITUS | On arrival to the operating room, the parturients were placed in the right lateral decubitus position. Before anesthesia induction, the gastric antral cross-sectional area (CSA) was measured using a Venue 40 (GE Healthcare, Tokyo, Japan) ultrasound system with a 2 to 5 MHz curvilinear array low-frequency 4 C-RS probe to measure gastric emptying [The gastric antrum was generally imaged in the parasagittal plane just right of the midline of the epigastric area in parturients, surrounded by the left lobe of the liver anteriorly and pancreas posteriorly. The CSA of the antrum was calculated according to the formula described by Bolondi et al. [
Ultrasonographic image of the gastric antrumThe figure demonstrates two perpendicular diameters, line 1 and line 2, for cross-sectional area of the stomach antrumLine 1: Craniocaudal antral diameterLine 2: Anteroposterior antral diameterL, liver; F, fetal head | PMC10466736 | |
Anesthesia methods | hypotension, bleeding, obstruction of the catheter | QUINCKE, BLEEDING, BLOOD CLOT, SECONDARY, BLOOD, DECUBITUS | After the ultrasound examination, routine monitoring, including heart rate (HR), blood pressure, electrocardiogram, and peripheral oxygen saturation, was implemented, and baseline values were recorded. Blood samples were collected after inserting a peripheral venous catheter, and a rapid infusion of 6% hydroxyethyl starch (HES) 130/0.4 (Voluven®, Fresenius Kabi Japan, Tokyo, Japan) was started; a total of 1000 mL was administered during surgery. Subsequently, we placed the parturients in the lateral decubitus position and attempted CSEA. All parturients underwent epidural catheterization before spinal anesthesia. An 18-gauge Tuohy needle was introduced using loss of resistance to air to confirm the epidural space. A 19-gauge epidural catheter was inserted through the epidural needle, 3–4 cm into the Th12/L1 epidural space. Instead of an epidural test dose, we injected 2 mL saline through the epidural catheter to prevent obstruction of the catheter by a blood clot. During skin closure, the parturient received continuous epidural infusion of 0.2% ropivacaine for postoperative analgesia.All parturients received spinal anesthesia at the L3–4 interspace using a 25-gauge Quincke spinal needle (TOP Corp, Tokyo, Japan). Next, 0.5% hyperbaric bupivacaine (8 mg) mixed with fentanyl (20 µg) was administered intrathecally after free flow of cerebrospinal fluid was observed. According to the results of the pinprick tests, the surgeon commenced the operation once a sensory blockade above the T4 level was achieved. Vasopressors were administered when the systolic blood pressure was < 90 mmHg or decreased by > 20% of the baseline value. As a vasopressor, 1 mL phenylephrine (1 mg diluted to 10 mL [0.1 mg/mL] with normal saline) was administered for hypotension with HR ≥ 60 beats/min or 1 mL ephedrine (40 mg diluted to 8 mL [5 mg/mL] with normal saline) for hypotension with HR < 60 beats/min. We counted the administration of 0.1 mg of phenylephrine or 5 mg ephedrine as one dose.The primary outcome of this study was the total number of vasopressor boluses and dose of vasopressors among the three groups. The secondary outcomes were the CSA of the stomach antrum, maternal plasma glucose levels, serum sodium levels, total intravenous fluid, bleeding volume, urine volume, operative time, and cord blood gas values after delivery. | PMC10466736 |
Data processing and analysis | A power analysis showed that 16 parturients per group would provide an α value of 0.05 and a β value of 0.1, based on the total dose of vasopressors during cesarean section in a pilot study of 10 parturients. The Kruskal–Wallis test was used for comparison between groups, followed by Dunn’s post hoc test for pairwise comparisons. Data are presented as median and interquartile range. All statistical analyses were performed using GraphPad Prism® version 6.01 (GraphPad Software, Inc., La Jolla, CA), and | PMC10466736 | ||
Results | Sixty-one parturients were enrolled in this study and randomized into one of the three groups. The CONSORT diagram is shown in Fig.
CONSORT flow diagram of study recruitmentCSA, cross-sectional area
Baseline characteristics of study parturientsValues are presented as median [interquartile range]. Group O denotes the ORS group, Group C denotes the control group, Group M denotes the mineral water group, and n denotes sample size | PMC10466736 | ||
BMI, body mass index | SECONDARY, COMPLICATIONS | The Kruskal–Wallis test indicated a statistically significant difference in the total number of vasopressor boluses used (There was no significant difference in secondary outcome among the three groups (Table Furthermore, no side effects or serious complications were observed in any of the groups.
The total number of vasopressor boluses after inducing combined spinal epidural anesthesia. The probability was calculated using the Kruskal–Wallis test by ranks. A pairwise comparison was performed using Dunn’s test if the Kruskal–Wallis test was significant*Group O < Group Cn.s., not significant
The total dose of phenylephrine after inducing combined spinal epidural anesthesia. The probability was calculated using the Kruskal–Wallis test by ranks. A pairwise comparison was performed using Dunn’s test if the Kruskal–Wallis test was significant**Group O < Group Cn.s., not significant
Primary and secondary outcomes
Data are expressed as median [interquartile range]CSA: cross-sectional area; BE: base excess; PCO | PMC10466736 | |
Discussion | nausea or vomiting, ®, vomiting, dehydration, hypotension, gastroesophageal sphincter | COMPLICATIONS, UTERUS, DEHYDRATION, SAID, INSULIN RESISTANCE, DELAYED GASTRIC EMPTYING | In this prospective randomized study of 51 parturients undergoing scheduled cesarean section, we found that PORT with OS-1® reduced the number of vasopressor boluses and phenylephrine doses during surgery compared with the fasting group. In addition, gastric emptying in healthy parturients was not delayed after drinking 500 mL of clear fluid 2 h before cesarean section compared to that in the fasting group. Similarly, a previous study concluded that PORT prevents hypotension after spinal anesthesia induction [In this study, we used OS-1®, which meets the oral rehydration therapy guidelines recommended by the World Health Organization and is a balanced mixture of water, glucose, and electrolytes [Generally, parturients are at an increased risk of anesthesia aspiration. An increase in the intragastric pressure due to the gravid uterus, a relaxed gastroesophageal sphincter due to the increased progesterone level, and delayed gastric emptying during pregnancy contribute to the risk. For this reason, although recent guidelines recommend the intake of clear liquids at least 2 h before elective surgery, [Regarding the safety of PORT, we found that as the ORS is highly absorbable and has a short stagnation time in the stomach, ultrasound assessment of the gastric antral CSA in parturients did not increase. There was no apparent or potential risk of aspiration, vomiting, or other drink-related complications before, during, or after surgery. Therefore, we confirmed, by ultrasound, that 500 mL of ORS 2 h before surgery could be acceptable in parturients undergoing cesarean section under spinal anesthesia.Preoperative infusion is said to be equally effective for the prevention of dehydration during the induction of anesthesia [In the present study, the ORS group showed significant differences from the fasting group in regards to the suppression of circulatory changes; however, ORS and mineral water did not show significant differences. Regarding excretion from the stomach, water and ORS were excreted at rates similar to those in previous studies on healthy adults. Thus, ORS is well excreted from the stomach; in addition, previous research has shown that ORS can correct electrolytes and reduce insulin resistance [Nonetheless, our study has some potential limitations. First, as it was impossible to obtain informed consent for emergent cesarean section because of the study protocol; all participants had scheduled elective cesarean sections. We also did not include parturients with complications or ASA physical status class ≥ III. This may limit the generalizability of our conclusions to more severe cases. Accordingly, further studies are needed to confirm whether the results would differ in such cases. Second, it was not a blinded clinical trial because of the taste of the drink, which may have increased the bias. However, the data were analyzed by a study investigator who was not involved in providing anesthesia. Third, although preoperative drinking could cause perioperative nausea or vomiting, this effect was not examined in the present study and is an issue for future research. Finally, sonographic gastric examination is often difficult, especially because pregnancy increases the technical difficulty. | PMC10466736 |
Acknowledgements | CROSS | We would like to express our sincere gratitude to all the participants for their support and contribution to this research. We greatly appreciate the assistance from Obstetrics and Gynecology physicians, operating room medical staff, and 4 A ward medical staff of Kushiro Red Cross Hospital. Part of the data in this study was presented at the American Society of Anesthesiologists Annual meeting (Chicago, 2016). | PMC10466736 | |
Authors’ contributions | E.I. and T.S. substantially contributed to the study conceptualization. E.I. and T.S. significantly contributed to data analysis and interpretation. C.M. substantially contributed to the manuscript drafting. All authors critically reviewed and revised the manuscript draft and approved the final version for submission. | PMC10466736 | ||
Funding | Not applicable. | PMC10466736 | ||
Data Availability | The datasets used and analyzed during the current study are available from the corresponding author on request. | PMC10466736 | ||
Declarations | PMC10466736 | |||
Ethics approval and consent to participate | CROSS | This study was approved by the Ethics Committee of Kushiro Red Cross Hospital (Hokkaido, Japan) and is registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN000019825). All the methods in our study were conducted in accordance with the Declaration of Helsinki. The trial was conducted from February 2014 to July 2017 at Kushiro Red Cross Hospital, Japan, which is affiliated with the Department of Anesthesiology and Critical Care Medicine of Asahikawa Medical University. Written informed consent was obtained from all participants at least 24 h before the operation. | PMC10466736 | |
Consent for publication | Not applicable. | PMC10466736 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10466736 | ||
Abbreviations | anteroposterior diameterAmerican Society of Anesthesiologistscross-sectional areacombined spinal epidural anesthesiacraniocaudal diameteroral rehydration solutionpreoperative oral hydration therapy | PMC10466736 | ||
References | PMC10466736 | |||
Background | cognitive impairment | Responsiveness and minimal clinically important difference (MCID) are critical indices to understand whether observed improvement represents a meaningful improvement after intervention. Although simultaneous cognitive-exercise training (SCET; e.g., performing memory tasks while cycling) has been suggested to enhance the cognitive function of older adults, responsiveness and MCID have not been established. Hence, we aimed to estimate responsiveness and MCIDs of two dual task performance involving cognition and hand function in older adults with and without cognitive impairment and to compare the differences in responsiveness and MCIDs of the two dual task performance between older adults with and without cognitive impairment. | PMC10580601 | |
Methods | A total of 106 older adults completed the Montreal Cognitive Assessment and two dual tasks before and after SCET. One dual task was a combination of Serial Sevens Test and Box and Block Test (BBT), and the other included frequency discrimination and BBT. We used effect size and standardized response mean to indicate responsiveness and used anchor- and distribution-based approaches to estimating MCID ranges. When conducting data analysis, all participants were classified into two cognitive groups, cognitively healthy (Montreal Cognitive Assessment ≥ 26) and cognitively impaired (Montreal Cognitive Assessment < 26) groups, based on the scores of the Montreal Cognitive Assessment before SCET. | PMC10580601 | ||
Results | In the cognitively healthy group, Serial Seven Test performance when tasked with BBT and BBT performance when tasked with Serial Seven Test were responsive to SCET (effect size = 0.18–0.29; standardized response mean = 0.25–0.37). MCIDs of Serial Seven Test performance when tasked with BBT ranged 2.09–2.36, and MCIDs of BBT performance when tasked with Serial Seven Test ranged 3.77–5.85. In the cognitively impaired group, only frequency discrimination performance when tasked with BBT was responsive to SCET (effect size = 0.37; standardized response mean = 0.47). MCIDs of frequency discrimination performance when tasked with BBT ranged 1.47–2.18, and MCIDs of BBT performance when tasked with frequency discrimination ranged 1.13–7.62. | PMC10580601 | ||
Conclusions | cognitive impairment | Current findings suggest that a change in Serial Seven Test performance when tasked with BBT between 2.09 and 2.36 corrected number (correct responses – incorrect responses) should be considered a meaningful change for older adults who are cognitively healthy, and a change in frequency discrimination performance when tasked with BBT between 1.47 and 2.18 corrected number (correct responses – incorrect responses) should be considered a meaningful change for older adults who are cognitively impaired. Clinical practitioners may use these established MCIDs of dual tasks involving cognition and hand function to interpret changes following SCET for older adults with and without cognitive impairment. | PMC10580601 | |
Trial registration | NCT04689776, 30/12/2020. | PMC10580601 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12877-023-04390-3. | PMC10580601 | ||
Keywords | PMC10580601 | |||
Introduction | It is estimated that 22% of the world’s population will be people aged 60 years and older by 2050 [Based on the guided plasticity facilitation framework, combined cognitive and physical training has been designed to enhance cognitive abilities [Numerous studies on SCET have adopted multicomponent interventions, which have shown promising results in improving cognitive function in older adults with and without CI [Dual task paradigm is a procedure in which an individual is required to simultaneously perform two tasks, and each task involves a distinct goal [Cognition in dual task performance involves executive functions (EFs), a collection of top-down cognitive control processes [To assess meaningful and observed changes following an intervention, the degree of beneficial effect must be determined and is usually indicated by responsiveness and minimal clinically important difference (MCID). Responsiveness is defined as the ability of a measure to detect a change in a construct that is being assessed over a specific period [While there have been studies that examine dual task walking performance after training, no studies have estimated the responsiveness and MCID of dual tasks involving hand function or walking post-intervention in any population. On the other hand, MCID estimates of a measure may vary across populations with differing levels of cognitive function [The aims of this study were to (1) establish the responsiveness and MCID of dual task performance involving cognition and hand function for older adults with and without CI following SCET, and (2) compare the differences in responsiveness and MCID of dual task performance involving cognition and hand function between older adults with and without CI following SCET. | PMC10580601 | ||
Methods | PMC10580601 | |||
Participants | cognitive complaints, asthma, dementia, neurological disorders | HEART FAILURE, MYOCARDIAL INFARCTION, ASTHMA, NEUROLOGICAL DISORDERS | This study is an ongoing clinical trial study, and the study protocol for this intervention has been approved by the local institutional review board (#201912EM016). Participants’ inclusion criteria were (1) age of 60 years or over, (2) able to follow instructions (Mini-Mental State Evaluation ≥ 20), (3) without difficulties in basic activities of daily living, (4) self- or informant-report cognitive complaints, and (5) without a diagnosis of dementia by physicians. Participants who were diagnosed with neurological disorders or having an unstable medical condition (e.g., recent myocardial infarction, heart failure, recent heart surgery, or severe asthma) were excluded from this study. | PMC10580601 |
Procedure | BLIND | All participants were invited from adult day care centers or community facilities and were screened to ensure their eligibility for this study. After participants provided written informed consent, they participated in SCET and completed measures before and after SCET. Research assistants were responsible for implementing all measures in this study. To minimize potential confounding effects, the measures conducted before and after SCET were scheduled on different days and did not occur on the same day as the SCET. This approach ensured that the assessments were conducted independently and allowed for a precise evaluation of the effects of the SCET intervention.Instructors who conducted the intervention were qualified occupational therapists. To minimize the staff training weakness because of multi-site sampling, all instructors received standardized training on the concepts of SCET. Instructors were not involved in the assessments and were blind to the cognitive status of all participants. Their lack of involvement in the assessments ensured objectivity and minimized potential biases that could arise from their knowledge of the participants’ cognitive level.At the data analysis stage, all participants were divided into two cognitive groups based on their performance on MoCA before SCET, CH (MoCA ≥ 26), and CI (MoCA < 26) [
Flow diagram of screening, intervention, measurement, and final sample included in data analysis | PMC10580601 | |
Intervention | instruction-practice, visual or verbal instructions, cognitive and exercise tasks, visual or auditory cues/instructions | ADVERSE EFFECTS, SHOP | The SCET was developed as an arm of a larger project focused on combined training for older adults. The overarching goal of SCET was to improve cognitive function. Participants were instructed to concurrently perform cognitive and exercise tasks, with greater emphasis on cognitive components. It was led by qualified occupational therapists who served as in-person instructors. Throughout the SCET intervention, participants had the opportunity to receive feedback from the in-person instructor. The program consisted of 90–120 min, once a week, for 12 weeks in a group-based setting.Each session was divided into two parts: instruction-practice and training sessions. The instruction-practice session began with a warm-up (10 min), followed by exercise activities (15–20 min). Subsequently, cognitive components were introduced and integrated (20–25 min). The primary aim of this session was to familiarize participants with the simultaneous performance of cognitive and exercise tasks. Following a 10-minute break, the training session commenced. Initially, dual task training was performed for 20–25 min, followed by a short 5-min break, and then another 20–25 min of dual task training. The session concluded with a 5-minute cool-down stretching routine. The primary aim of this session was to make participants implement dual tasks they had learned during the instruction-practice session and actively engaged in dual task training. The time structure of the SCET intervention is illustrated in Fig.
Time structure of the SCET interventionEach SCET session encompassed cognitive and physical components.The cognitive components consisted of attention, processing speed, memory, calculation, and language. Each session incorporated one or more of these cognitive components. Attention activities involved tasks such as responding to visual or auditory cues/instructions as well as identifying or differentiating colors, shapes, amounts, or sizes of pictures. Processing speed activities required participants to answer questions or follow visual or verbal instructions within a limited time period. Memory activities involved repeating a series of digits or words after seeing or hearing them, performing a series of visual or verbal instructions after seeing or hearing them, and remembering visual images, shapes, or colors. Calculation tasks included answering arithmetic questions presented on the screen or determining the total amount of items taken from the simulated shop or a shopping list. Language tasks encompassed naming fruits, animals, places, or objects in specific environments, as well as constructing logical stories based on a series of given pictures.The physical components of the program consisted of stretching, aerobic exercise, muscle-strengthening exercise, and balance exercise. Participants were encouraged to exercise at moderate intensity, targeting 50–70% of their maximum heart rate. The warm-up and cool-down included upper and lower limb stretching. Aerobic activities involved walking, marching on the spot, and tapping the floor with toes or heels. Balance activities included standing with a narrow base, cross-stepping, and kicking a ball. Muscle-strengthening exercises involved carrying objects and performing upper limb workouts with weighted bottles (filled with water) (e.g., bicep curls, overhead triceps press), as well as lower limb workouts with or without elastic bands (e.g., squats, lunges).During the SCET, attention, processing speed, memory, calculation, and language tasks were performed simultaneously with aerobic, muscle-strengthening, and balance exercises. Stretching exercises were integrated into the warm-up and cool-down portions of the session and were not paired with specific cognitive components. The pairings of cognitive and exercise tasks varied throughout the intervention, with cognitive and physical demands progressively increasing over trials. For instance, the number of words to be recalled or the resistance of the elastic bands used in exercises increased throughout the program. The adaptation of cognitive task difficulty was based on participants’ performance in the previous session. In cases where the cognitive component’s difficulty level was augmented, the difficulty level of the corresponding physical component remained constant. This approach was adopted to prevent potential adverse effects on participants’ performance, ensuring they were not overwhelmed by the task requirements. However, given the group-based training, the adjusted difficulty level of cognitive tasks may not have been perfectly tailored to each participant’s individual capabilities. | PMC10580601 |
Measures | The MoCA was used to assess global cognition and was chosen as the external criterion for anchor-based MCID estimates. Two dual tasks were used to assess dual task performance. | PMC10580601 | ||
MoCA | The MoCA is a sensitive and validated tool [ | PMC10580601 | ||
Dual tasks | visual or auditory cues | The two dual tasks that we designed in this study were: (1) Serial Seven Test (SST) and Box and Block Test (BBT; SST and BBT performed concurrently for 60 s) and (2) frequency discrimination (FD) and BBT (FD and BBT performed currently for 60 s).The SST is intended to evaluate working memory [SST: a participant is asked to repeatedly count backward by seven which begins with 300 (i.e., subtract 7 from 300), and to report their answer to each subtraction. Correct and incorrect responses to SST are recorded, and the corrected number which is the difference between correct and incorrect responses is calculated.BBT: a participant is seated at a table and presented with a rectangular box divided into two square compartments and there are 150 colored wooden blocks in one compartment. A participant is instructed to move a block, one at a time, from one compartment to the other as many as they can in 60 s [FD: a participant is required to discriminate between either high (1000 Hz) or low (500 Hz) pitch presented by speakers and to report their answer. There was a total of 18 trials conducted in 60 s. Specifically, there were nine trials involving high-pitch sounds and nine trials involving low-pitch sounds. The presentation of both high- and low-pitch sounds was randomized, and the intervals between the sounds ranged randomly from 1 to 4 s. Correct and incorrect responses to FD are recorded, and the corrected number which is the difference between correct and incorrect responses is calculated.We focused on dual task performance and each dual task included cognitive and physical performance. We reported both cognitive and physical performance for each dual task. SST performance when tasked with BBT indicated the cognitive performance, the corrected number of SST, in the dual task of SST and BBT. BBT performance when tasked with SST indicated the physical performance, the number of blocks, in the dual task of SST and BBT. FD performance when tasked with BBT indicated the cognitive performance, the corrected number of FD, in the dual task of FD and BBT. BBT performance when tasked with FD indicated the physical performance, the number of blocks, in the dual task of FD and BBT.Before engaging in dual tasks, participants had the opportunity to practice SST, FD, and BBT under single task conditions. Research assistants provided instructions on how to perform the dual tasks, and participants were given two practice sessions to ensure a comprehensive understanding of how to successfully perform the dual tasks before undergoing evaluation.Near and far transfer refers to the extent to which the benefits of training on a specific task can be applied to other tasks. Near transfer occurs when skills gained from a training task can be readily applied to tasks with similar processes or demands. It typically occurs when the training and the transfer tasks are closely related. On the other hand, far transfer involves the generalization of learning to tasks with dissimilar processes and demands. In this case, the acquired skills are applied to domains that may not share obvious similarities with the trained task [The cognitive components of SCET included attention and calculation tasks. The attention activities involved various tasks, such as responding to visual or auditory cues and instructions. FD required participants to determine high- or low-pitch sounds, which showed some similarity to responding to auditory cues, making it a relatively near transfer task. Similarly, the calculation activities involved answering arithmetic questions and determining the total amounts. SST required participants to perform serial subtraction by 7, mental arithmetic, making it another relatively near transfer task. Regarding the physical components, participants engaged in muscle-strengthening exercises by grasping bottles filled with water as weights or using elastic bands. While grasping was incorporated into both BBT and SCET, the patterns of grasping blocks and bottles/elastic bands were not quite similar. As a result, BBT was considered a relatively far transfer task. | PMC10580601 | |
Data analysis | Descriptive statistics were used to summarize the demographic characteristics of all participants. We used the standardized response mean (SRM) and effect size (ES) to evaluate the responsiveness of the two groups on two dual task performance. The formula for these statistics are as follows, where D = raw score change on measure between pre- and post-intervention; SD = standard deviation at pre-intervention; SDWe used distribution-based and anchor-based approaches to estimate the MCID of dual task measures. Distribution-based MCID is calculated as one-half of the SD of all participants at pre-intervention [ | PMC10580601 |
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