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Abbreviations:
overweight
CHRONIC DISEASES, OBESE
body mass indexgut microbiotawaist circumferenceClinicalTrials.gov Identifier: NCT05667038. Saudi Food and Drug Authority (SFDA) on 12/8/2021, SCTR No. 21070702.The authors have no conflicts of interest to disclose.This study was funded by Chair for Biomarkers of Chronic Diseases (CBCD) KSU.Data sharing not applicable ...
PMC10118337
References
PMC10118337
Key Points
PMC10690466
Question
chronic stroke
What is the cost-effectiveness of exercise or cognitive and social enrichment activities to improve cognition among older adults with chronic stroke?
PMC10690466
Findings
Cognitive and social enrichment
In this economic evaluation with 120 older adults from a randomized clinical trial, the multicomponent exercise program conducted over a 6-month period was cost-effective for cognitive function, with limited impact on health-related quality of life. Cognitive and social enrichment activities incurred higher costs compa...
PMC10690466
Meaning
chronic stroke
These findings suggest that multicomponent exercise may be a cost-effective approach to improving cognitive function in older adults with chronic stroke.This economic evaluation is a cost-effectiveness and cost-utility analysis of multicomponent exercise or cognitive and social enrichment activities compared with a bal...
PMC10690466
Importance
chronic stroke, stroke, Cognitive impairment
STROKE
Cognitive impairment is prevalent in survivors of stroke, affecting approximately 30% of individuals. Physical exercise and cognitive and social enrichment activities can enhance cognitive function in patients with chronic stroke, but their cost-effectiveness compared with a balance and tone program is uncertain.
PMC10690466
Objective
To conduct a cost-effectiveness and cost-utility analysis of multicomponent exercise or cognitive and social enrichment activities compared with a balance and tone program.
PMC10690466
Design, Setting, and Participants
stroke
STROKE
This economic evaluation used a Canadian health care systems perspective and the Vitality study, a randomized clinical trial aimed at improving cognition after stroke with a 6-month intervention and a subsequent 6-month follow-up (ie, 12 months). The economic evaluation covered the duration of the Vitality trial, betwe...
PMC10690466
Interventions
Participants were randomly assigned to twice-weekly classes for 1 of the 3 groups: multicomponent exercise program, cognitive and social enrichment activities program, or a balance and tone program (control).
PMC10690466
Main Outcomes and Measures
Alzheimer Disease
ALZHEIMER DISEASE
The primary measures for the economic evaluation included cost-effectiveness (incremental costs per mean change in cognitive function, evaluated using the Alzheimer Disease Assessment Scale–Cognitive-Plus), cost-utility (incremental cost per quality-adjusted life-year gained), intervention costs, and health care costs....
PMC10690466
Results
Alzheimer Disease, CAD
ALZHEIMER DISEASE, CAD
Among 120 participants (mean [SD] age, 71 [9] years; 74 [62%] male), 34 were randomized to the multicomponent exercise program, 34 were randomized to the social and cognitive enrichment activities program, and 52 were randomized to the balance and tone control program. At the end of the 6-month intervention, the cost p...
PMC10690466
Conclusions and Relevance
chronic stroke
The findings of this economic evaluation suggest that exercise demonstrated potential for cost-effectiveness to improve cognitive function in older adults with chronic stroke during a 6-month intervention.
PMC10690466
Introduction
poststroke cognitive impairment, death, disability, Stroke
STROKE
Stroke is a significant global public health concern, ranking as the second leading cause of death worldwide and a leading cause of serious disability.While there are currently no pharmacological interventions approved for poststroke cognitive impairment, interventions, such as exercise and cognitive training, have sho...
PMC10690466
Methods
This economic evaluation used data from a randomized clinical trial, approved by the University of British Columbia’s Clinical Research Ethics Board and the Vancouver Coastal Health Research Institute. Prior to participating in the study, all participants provided written and informed consent. The trial was registered ...
PMC10690466
Study Design
chronic stroke
We conducted an economic evaluation alongside the Vitality study, a 3-group RCT that examined the efficacy of exercise and cognitive and social enrichment activities to promote cognitive function in individuals with chronic stroke.
PMC10690466
Participants
RECRUITMENT
Details on participants recruitment were previously reported in the study protocol and the primary report.
PMC10690466
Measures
stroke, depression, Depression
STROKE
The Vitality study collected descriptive and demographic variables, including age, body mass index, biological sex, educational status, and stroke type. Cognitive function was assessed using the Mini-Mental State Examination,Secondary outcome measures included depression (assessed using the Center for Epidemiological S...
PMC10690466
Intervention
The 3 interventions consisted of 60-minute classes conducted twice a week for 26 weeks. Trained instructors led the classes, maintaining a ratio of 1 instructor for every 4 participants.
PMC10690466
Exercise
There were 34 participants randomized in the exercise group. Participants in the exercise group were involved in activities adapted from the community-based Fitness and Mobility Exercise program.
PMC10690466
Cognitive and Social Enrichment
word list memorization
There were 34 participants in the cognitive and social enrichment group. Participants engaged in cognitive exercises covering memory, learning, attention, and executive functions, alongside social and cognitive enrichment activities. Activities included word list memorization, brain training using a tablet application ...
PMC10690466
Active Control
STRETCHES
The balance and tone group included 52 participants. The program included stretches, deep breathing and relaxation techniques, general posture education, and core control exercises in the sitting position. This group served as a control for confounding variables, such as exercise received from community center visits a...
PMC10690466
Patient Engagement
poststroke
Participants in the Vitality study were not engaged as patient partners in the study design. Interested parties, such as neurologists and physiotherapists, who actively support poststroke care were part of the study team and involved in the study design.
PMC10690466
Costs
Health resource utilization was monitored using self-reported questionnaires at 3, 6, and 12 months.
PMC10690466
QALYs
QALYs were assessed using the area under the curve analysis of health state utility values obtained from the Euro-Quality of Life–3 Domains–5 Levels (EQ-5D-3L) questionnaire.
PMC10690466
Effectiveness
Alzheimer Disease
ALZHEIMER DISEASE
The Alzheimer Disease Assessment Scale–Cognitive-Plus (ADAS-Cog-Plus) was the primary measure of cognitive function.
PMC10690466
Overview of Economic Evaluation
Using a Canadian health care system perspective, we conducted a cost-effectiveness and cost-utility analysis alongside the Vitality RCT.
PMC10690466
Statistical Analysis
All analyses for this economic evaluation used Stata version 17 (StataCorp). Data were analyzed from June 1, 2022, to March 31, 2023.
PMC10690466
Cost-Effectiveness
The primary measure in the cost-effectiveness analysis was the incremental cost-effectiveness ratio (ICER), calculated by comparing the mean cost difference between intervention and control groups to the mean effectiveness difference, based on changes in ADAS-Cog-Plus after the 6-month exercise intervention. Although n...
PMC10690466
Cost-Utility Analysis
The outcome of the cost-utility analysis was the incremental cost-utility ratio (ICUR). The ICUR was calculated by ascertaining the mean difference in cost of providing the interventions compared with the control and dividing that by the mean difference in QALY. The difference in cost divided by the difference is utili...
PMC10690466
Base Case Analysis
The primary analysis estimated the ICERs and ICURs using the complete case data set, which included subsets for cost-effectiveness analysis (participants with complete costs and ADAS-Cog-Plus score data) and cost-utility analysis (participants with complete costs and QALY data). The number and proportion of participant...
PMC10690466
Sensitivity and Subgroup Analyses
SENSITIVITY
Sensitivity analysis was conducted using multiple imputations to assess uncertainty regarding missing data handling. We also conducted 3 subgroup analyses to examine the cost-effectiveness variation among participants based on literature indicating differing costs and cost-effectiveness for different subgroups: partici...
PMC10690466
Results
Among 120 participants in the Vitality study, mean (SD) baseline age was 71 (9) years, and 74 (62%) were male (
PMC10690466
Participant Characteristics at Baseline
cognitive impairment, dementia, motor impairment, comorbid illnesses, Alzheimer Disease Assessment Scale-Cognitive, disability
Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); EQ-5D-3L, Euro-Quality of Life–3 Domains–5 Levels.Range, 0 (worst) to 30 (best); scores between 26 and 30 are considered within reference range.Range, 0 (worst) to 30 (best); scores between 24 and 30 are conside...
PMC10690466
Health Care Resource Use and Costs
Unit costs for health care cost items are presented in
PMC10690466
Unit Cost Items for Health Care Resource Utilization for Participants in the Vitality Study
Abbreviation: NA, not applicable.Estimated from Vitality study expense records.Estimated from 2021 British Columbia Medical services plan.Calculated from the Vancouver General Hospital fully allocated cost model.
PMC10690466
Results of Cost-Effectiveness and Cost-Utility Analyses for Vitality Study at End of Intervention and Follow-Up
CAD
REGRESSION, CAD
Abbreviations: ICER, incremental cost-effectiveness ratio; ICUR, incremental cost-utility ratio; NA, not applicable; QALY, quality-adjusted life-year.There is no willingness-to-pay threshold for which we can be 95% confident that the 2 therapies differed in value.QALYs are adjusted for baseline utility using a linear r...
PMC10690466
QALYs
cognitive and social enrichment
REGRESSION
The mean (SD) adjusted incremental QALYs at the end of the 6-month intervention was 0.009 (0.008) QALYs for exercise vs balance and tone groups and 0.010 (0.009) QALYs for cognitive and social enrichment vs balance and tone groups. The mean (SD) adjusted incremental QALYs after follow-up was 0.002 (0.008) years for exe...
PMC10690466
Cost-Effectiveness of Exercise Program vs Balance and Tone Program at 6 Months
Alzheimer Disease
ALZHEIMER DISEASE
A. Orange lines indicate 0 on the x and y axes; orange dots, incremental cost effectiveness ratio estimates; light blue line and circles, 5000 bootstrapped estimates. B. Gray line indicates probability of incremental cost effectiveness ratio acceptance for different willingness-to-pay thresholds. ADAS-Cog-Plus indicate...
PMC10690466
Cost Utility of Exercise Program and Cognitive and Social Enrichment Program vs Balance and Tone Program at 6 and 12 Months
Thick orange lines indicate 0 on the x and y axes; orange dots, incremental cost effectiveness ratio estimates; circles, 5000 bootstrapped estimates; QALY, quality-adjusted life-year.
PMC10690466
Sensitivity and Subgroup Analyses
HEMORRHAGIC STROKE
Exercise was cost-effective for improving cognitive function, but not quality of life. Subgroup analyses revealed cost savings for exercise in participants aged 80 years and older, as well as participants who had a hemorrhagic stroke. The sensitivity analysis using imputed data produced results consistent with the base...
PMC10690466
Discussion
chronic stroke, cognitive and social enrichment, cognitive improvements
This economic evaluation using data from the Vitality study found that at the end of the 6-month intervention, the exercise program was more effective in improving cognitive function among older adults with chronic stroke at additional cost compared with the control balance and tone program. As demonstrated by the prim...
PMC10690466
Limitations
This study has limitations. The time horizon of the economic evaluation may not capture the longer-term costs and benefits of the interventions.
PMC10690466
Conclusions
chronic stroke, stroke, Cognitive and social enrichment
STROKE
This economic evaluation provides novel evidence supporting the potential for multicomponent exercise as a cost-effective intervention for improving cognitive function in older adults with chronic stroke and reducing the economic burden of stroke. Cognitive and social enrichment activities show promise for improving co...
PMC10690466
Background
Impairments of trunk movements, stroke, thoracic movements, orthosis, AFOs, gait of stroke, AFO
STROKE
Impairments of trunk movements in gait of stroke are often reported. Ankle foot orthosis (AFO) is commonly used to improve gait of stroke; however, the effect of different types of AFOs on the pelvic and thoracic movements during gait in stroke has not been clarified.
PMC9901085
Methods
stroke, AFO
STROKE
Thirty-four patients with stroke were randomly allocated to undergo 2 weeks of gait training by physiotherapists while wearing a rigid AFO (RAFO) with a fixed ankle or an AFO with an oil damper (AFO-OD) that provides plantarflexion resistance and free dorsiflexion. A motion capture system was used for measurements of s...
PMC9901085
Results
AFOs
INTERACTIONS
Twenty-nine patients completed the study (AFO-OD group: 14, RAFO group: 15). Interactions were found in pelvic rotation angle, change of shank-to-vertical angle (SVA) in the stance, and paretic to non-paretic step length, which increased in AFO-OD group with AFOs (
PMC9901085
Supplementary Information
The online version contains supplementary material available at 10.1186/s12938-023-01068-0.
PMC9901085
Keywords
PMC9901085
Background
Stroke, stoke, stroke, disability, orthosis, AFOs, hemiplegic, impairments of the trunk function, AFO
STROKE, STROKE
Stroke is the primary cause of mortality and disability for adults [Many studies found that variability of trunk movement increased significantly in the gait of stoke. The paretic pelvis was upward in the stance phase and downward in the swing phase, contrary to the healthy group [Moreover, the impairments of the trunk...
PMC9901085
Relevance
AFOs
The correlation coefficient between parameters that showed interactions within each group wearing AFOs in this study was calculated and is shown in Fig. Correlation coefficient between parameters: SVA was positively correlated with pelvic tilt at contralateral foot off (
PMC9901085
Discussion
spasticity, thoracic movements, stroke, AFOs, knee flexion phenomenon, knee hyperextension, knee pain, AFO
STROKE
In the current study, we evaluated the effect of two AFOs, namely, AFO-OD and RAFO on the pelvic and thoracic movements in the gait of stroke patients after two weeks of training. Our results proved the hypothesis that there were direct effects on the thorax and pelvis movement using different AFOs in patients with str...
PMC9901085
Conclusion
stroke, AFOs, AFO
STROKE
This randomized controlled trial assessed the effect of different types of AFOs on gait with stroke by comparing the effects of a rigid AFO, which relatively stopped both dorsiflexion and plantarflexion, and the AFO-OD which generated plantarflexion and enabled free dorsiflexion. The findings in 29 patients with stroke...
PMC9901085
Methods
PMC9901085
Participants
musculoskeletal or cognitive problems, subacute stroke, spasticity, AFO
A total of 34 patients with subacute stroke (more than 14 and less than 180 days after onset) who were hospitalized for rehabilitation treatment in a rehabilitation facility in China from June 2020 to August 2021 participated in this study. The following inclusion criteria and exclusion criteria were applied. The inclu...
PMC9901085
AFOs and equipment
ankle joints, damper joints, AFOs, metatarsophalangeal joints, AFO
The two types of AFOs shown in Fig. AFOs used in this study. A schematic design of the AFO with oil damper unit. The oil damper unit consists of a hydraulic cylinder(1), a ring portion metal plate (2), and a metal plate (3). An adjustment screw (4) controls the flow rate of the oil by varying the orifice diameter; the ...
PMC9901085
Study protocol
AFOs, hemiplegic, AFO
First, shod gait without AFO was measured at each participant’s self-selected walking speed in an 8-m walkway. Each participant was required to land their hemiplegic lateral foot exactly intact on one of the force platforms during one test and repeat three times. We divided the gait cycle according to the ground reacti...
PMC9901085
Data processing
pelvic, AFOs
Marker trajectories and force plate data were low-pass filtered by a second-order Butterworth filter with cutoffs of 6 and 18 Hz, respectively. The gait cycle was defined as the loading response, single stance, preswing, and swing phase of the paretic limb. These phases were distinguished by the vertical component of t...
PMC9901085
Statistical analysis
AFOs, AFO
All gait parameters were calculated as the average of three gait cycles for each condition, with/without an AFO before training and after training. All data were checked for normality distribution by the Shapiro–Wilk test.First, we compared the consistency of the baseline data, including the first shod gait data withou...
PMC9901085
Acknowledgements
The authors would like to acknowledge the support from China Rehabilitation Science Institute and China Rehabilitation Research Centre for this research. They also thank all patients who participated in this study and the physiotherapists who assisted with gait training and obtaining measurements.
PMC9901085
Author contributions
HL
RECRUITMENT
HL, JZ, L-F C, and SY conceptualized and designed the study. JZ and L-F C provided clinical support and clinical resources for experiments. HZ, HG, and L-F C performed patient recruitment physical therapy and data collection. HL, X-Q C, and Z-Y G performed data analysis and interpretation. HL drafted the manuscript. X-...
PMC9901085
Funding
This research is funded by National Key R&D Program of China (Grant 2020YFC2007604, 2022YFC3600305) and Fundamental Research Funds for Central Public Welfare Research Institutes (Grant 2020CZ-6,2021CZ-11, 2022CZ-2).
PMC9901085
Availability of data and materials
The raw data were generated at China Rehabilitation Research Center. Derived data supporting the findings of this study are available from the author H.L. on request.
PMC9901085
Declarations
PMC9901085
Ethics approval and consent to participate
All procedures were approved by the local ethics committee of the International University of Health & Welfare (No.19 Io-144–2) and China Rehabilitation Research Center(2019–116-2). Trial registration:UMIN000038694, Registered 21 November 2019,
PMC9901085
Consent for publication
Not applicable.
PMC9901085
Competing interests
The authors declare that they have no competing interests.
PMC9901085
References
PMC9901085
Abstract
PMC10256891
Introduction
Learned smoking cues from a smoker’s environment are a major cause of lapse and relapse. Quit Sense, a theory-guided Just-In-Time Adaptive Intervention smartphone app, aims to help smokers learn about their situational smoking cues and provide in-the-moment support to help manage these when quitting.
PMC10256891
Methods
A two-arm feasibility randomized controlled trial (
PMC10256891
Results
Self-reported smoking outcome completion rates at 6 months were 77% (95% CI 71%, 82%), viable saliva sample return rate was 39% (95% CI 24%, 54%), and health economic data 70% (95% CI 64%, 77%). Among Quit Sense participants, 75% (95% CI 67%, 83%) installed the app and set a quit date and, of those, 51% engaged for mor...
PMC10256891
Conclusions
Evaluation feasibility was demonstrated alongside evidence supporting the effectiveness potential of Quit Sense.
PMC10256891
Implications
RECRUITMENT
Running a primarily automated trial to initially evaluate Quit Sense was feasible, resulting in modest recruitment costs and researcher time, and high trial engagement. When invited, as part of trial participation, to install a smoking cessation app, most participants are likely to do so, and, for those using Quit Sens...
PMC10256891
Introduction
The total number of smokers worldwide is increasing,Any smoking early in a quit attempt (a “lapse”) is highly predictive of longer-term return to smoking (“relapse”),There is a lack of effective support to help smokers manage cue-induced cravings. Steady-state medications such as bupropion, Varenicline, and nicotine pa...
PMC10256891
Methods
PMC10256891
Design
A two-arm parallel randomized controlled feasibility trial, allocating smokers recruited online (1:1 ratio) to a “usual care” arm (referral to NHS SmokeFree website) or an intervention arm who received “usual care” plus an invitation to install the Quit Sense app. A nested qualitative process evaluation and a Study-Wit...
PMC10256891
Participants
Inclusion criteria were: A current smoker; aged 16 years and above; smoked at least 7 cigarettes per week; willing to make a quit attempt within 14 days of enrollment; own an Android smartphone (version 5.0 or above); a resident in England; able to provide informed consent; not having previously participated in the tri...
PMC10256891
Sample Size.
Sample size was based on achieving adequate precision for key “full trial” parameters. In line with guidance on feasibility trials with binary outcome measures,
PMC10256891
Procedure
RECRUITMENT, RECRUITMENT
Recruitment took place through paid-for online adverts with Facebook (including Instagram) and Google Search, limited to England-based IP addresses and targeted at Android devices. Online adverts were managed and optimized by a partner company called Nativve. Advert campaigns were run in two phases; from November 27, t...
PMC10256891
Randomization.
Randomization was stratified by smoking rate (<16 vs. ≥ 16 cigarettes/day; based on mean smoking rates from similar trials)
PMC10256891
Interventions
PMC10256891
Usual Care.
After randomization, both arms received an automated text message with a link to the NHS SmokeFree website (
PMC10256891
Quit Sense App.
smoking behavior, mood,Stage 2
Quit Sense arm participants also received an automated text message providing a link to the Quit Sense app on the Google Play store, along with a unique activation code. If the app had not been installed after 3 days, participants were sent a reminder text message to encourage installation. Five days later, if still no...
PMC10256891
Measures
At 6 weeks, participants were sent a text message with a questionnaire link, 1 day after receiving a prenotification text message alerting them to the questionnaire link message and a texted £5 Amazon voucher for completing it. A reminder text message was sent if the survey was not completed 4 days later, after which p...
PMC10256891
Feasibility Outcomes.
Feasibility outcomes used to estimate key parameters to inform a future trial included:Completeness of the anticipated primary outcome for a future definitive trial (see smoking outcomes).Abstinence rate of usual care arm (anticipated primary outcome).Advertising cost per recruit.Rates of app installation, use, and acc...
PMC10256891
Smoking and Related Outcomes.
As a feasibility trial, there was no primary outcome, but the anticipated primary abstinence outcome for any future definitive trial was based on the Russell standardHypothesized mechanisms of action collected at 6 weeks included lapse incidence in the first 2 weeks of a quit attempt or since enrollment if no attempt w...
PMC10256891
Analysis
REGRESSION, SENSITIVITY
Feasibility outcomes are described as proportions or summary statistics with 95% CIs. To estimate the intervention effect on abstinence, lapse incidence, and use of lapse prevention strategies, we used multiple logistic regression, providing ORs with 95% CIs, while adjusting for stratification variables and any prognos...
PMC10256891
Results
Smoking Dependence
There were 1275 study website landings from the online adverts, of which 323 (25%) people completed the eligibility assessment. Of those assessed for eligibility, 93% (299) were eligible and of those eligible, 70% (209) consented and were randomized (117 in phase one and 92 in phase two). One additional individual was ...
PMC10256891
Discussion
RECRUITMENT
This was the first randomized controlled trial of a JITAI smartphone app for smoking cessation that uses passive measurement to trigger behavioral support. The automated online trial design employed was feasible and successful in reaching the target sample size within the relatively short recruitment timeframe. The cos...
PMC10256891
Strengths and Limitations
coronavirus disease 2019
CORONAVIRUS DISEASE 2019, RECRUITMENT
One innovation employed was those trial procedures, other than manual follow-up and saliva sample posting, were fully automated once setup, meaning study running costs were relatively low. Approximately half of the participants did not require any human involvement at any stage of their trial involvement and for those ...
PMC10256891
Conclusions
The primarily automated trial design and processes for evaluating Quit Sense were feasible and enabled successful trial delivery within anticipated timeframes, cost, and participation rates. Evidence was consistent with Quit Sense leading to a higher rate of biochemically verified abstinence relative to usual care and ...
PMC10256891
Supplementary Material
A Contributorship Form detailing each author’s specific involvement with this content, as well as any supplementary data, are available online at Click here for additional data file.Click here for additional data file.
PMC10256891
Acknolwedgments
WEST, RECRUITMENT
The authors are very grateful to the following for their contribution, time and efforts in ensuring the success of this project: The participants, the patient and public involvement and engagement panel, Antony Colles and Claire West for database, website and data collection setup, Nativve, who managed the online recru...
PMC10256891
Funding
This study is funded by the NIHR Public Health Research Programme (17/92/31). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. Tim Coleman is an NIHR Senior Investigator.
PMC10256891
Declaration of Interests
PMC10256891
Data Availability
The data underlying this article will be shared on reasonable request to the corresponding author.
PMC10256891
References
PMC10256891
Background
Perturbation-based balance training (PBT) is an emerging intervention shown to improve balance recovery responses and reduce falls in everyday life in older adults. However, perturbation interventions were heterogeneous in nature and need improvement. This study aims to investigate the effects of a PBT protocol that wa...
PMC10191085
Methods
Community-dwelling older adults (age ≥ 65 years) who visited the hospital outpatient clinic due to a fall incident were included. Participants received PBT in addition to usual care (referral to a physiotherapist) versus usual care alone. PBT consisted of three 30-minute sessions in three weeks. Unilateral treadmill be...
PMC10191085