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Funding | POLAND | The study was funded by the National Science Centre in Poland under the grant no. 2019/35/N/HS6/04310. | PMC10115883 | |
Data availability | OSF | The data set used in analyses is available at OSF at | PMC10115883 | |
Competing interests | The authors declare no competing interests. | PMC10115883 | ||
References | PMC10115883 | |||
Introduction | acute stroke | ACUTE STROKE | Practicality of implementation and dosing of supplemental gait training in an acute stroke inpatient rehabilitation setting are not well studied but can have positive impact on outcomes. | PMC10552424 |
Objectives | stroke | STROKE | To determine the feasibility of early, intense supplemental gait training in inpatient stroke rehabilitation, compare functional outcomes and the specific mode of delivery. | PMC10552424 |
Design and setting | Assessor blinded, randomized controlled trial in a tertiary Inpatient Rehabilitation Facility. | PMC10552424 | ||
Participants | acute post-stroke, unilateral hemiparesis | Thirty acute post-stroke patients with unilateral hemiparesis (≥ 18 years of age with a lower limb MAS ≤ 3). | PMC10552424 | |
Intervention | Lokomat, ® | Lokomat® or conventional gait training (CGT) in addition to standard mandated therapy time. | PMC10552424 | |
Main outcome measures | PROM | ADVERSE EVENTS | Number of therapy sessions; adverse events; functional independence measure (FIM motor); functional ambulation category (FAC); passive range of motion (PROM); modified Ashworth scale (MAS); 5 times sit-to-stand (5x-STS); 10-m walk test (10MWT); 2-min walk test (2MWT) were assessed before (pre) and after training (post). | PMC10552424 |
Results | The desired supplemental therapy was implemented during normal care delivery hours and the patients generally tolerated the sessions well. Both groups improved markedly on several measures; the CGT group obtained nearly 45% more | PMC10552424 | ||
Conclusions | With careful planning, supplemental therapy was possible with minimal intrusion to schedules and was well tolerated. Participants showed meaningful functional improvement with relatively little supplemental therapy over a relatively short time in study. | PMC10552424 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12984-023-01243-3. | PMC10552424 | ||
Keywords | PMC10552424 | |||
Introduction | impaired trunk control and gait disability, Stroke | STROKE | Stroke is a major cause of impaired trunk control and gait disability. [It is well established by both animal [ | PMC10552424 |
Methods | PMC10552424 | |||
Study design and randomization | BLIND | This assessor blind, randomized feasibility and pilot study was conducted in a tertiary IRF. The study protocol was approved by the local Institutional Review Board (IRB). Figure Study design overview. Abbreviations used were | PMC10552424 | |
Participants | seizures, stroke, neurological injury or disorder, vascular disorders, fractures, cognitive deficits, lower limb peripheral nerve injury, skin lesions, osteoporosis | STROKE, VASCULAR DISORDERS, PULMONARY DISEASE, SKIN LESIONS, OSTEOPOROSIS | Patients with a recent stroke (on average, less than three weeks post-injury), admitted to an IRF were assessed for eligibility by their treating clinical team (physiatrist and/or physical therapist) between April 2017 and July 2019. Inclusion criteria were: (1) Adult (≥ 18 years of age) after first stroke; (2) able to tolerate ≥ 12 minutes of upright position using a tilt table, standing frame, body weight support (BWS) harness or assistance; (3) medical stability and cardiorespiratory status sufficient to tolerate aerobic exercise protocol. Exclusion criteria were: (1) MAS score 4 in ankle, knee or hip joints; (2) other neurological injury or disorder affecting the central nervous system; (3) previous lower limb peripheral nerve injury; (4) lower limb joint contractures that interfere with walking; (5) open skin lesions or anatomic deformities in the lower limbs and/or torso that may interfere with the Lokomat® exoskeleton or support harness application; (6) bone problems (non-consolidated fractures; unstable spine; and severe osteoporosis with history of fractures; (7) severe cognitive deficits; (8) recent cardiac or active pulmonary disease, labile blood pressure; (9) severe vascular disorders of the lower limbs; (10) scheduled elective surgery or other procedures during the study; (11) uncontrolled seizures; (12) pregnancy. All participants gave written informed consent before start of the study. Demographic and clinical characteristics collected included: sex, hemiparetic side, age, stroke type (hemorrhagic/ischemic), stroke onset date, LOS, days from informed consent form (ICF) signature to discharge and number of completed training sessions. The trial took place in an Inpatient Rehabilitation Facility (IRF) to which patients were transferred after acute care on day 4 to 10 post stroke. For this study, LOS refers to time in the IRF only. The therapist perceived exertion during delivery of supplemental training for both groups was documented using the modified RPE (Borg Scale). | PMC10552424 |
Interventions | Lokomat, ® | Lokomat® or conventional gait training (CGT) was provided in addition to the mandated three hours of conventional IRF therapy. Both groups received up to four 45-min individual gait training sessions per week. Treatment was well defined and standardized at the top level to the degree possible given the individualized nature of gait training. In each group, the protocol was focused on achieving the maximum number of steps as possible and active participation during the training time. How the therapist achieved this was based, in part, on walking ability for each participant. An overview of the structure and priority of activities and progression is discussed for both groups in the below paragraphs; additional details are provided in the Additional file | PMC10552424 | |
Lokomat® | Lokomat, BWS | The Lokomat® exoskeleton is comprised of two actuated hip and knee leg orthoses that are attached to the participant’s limbs and torso by cuffs and straps. Spring assisted ankle dorsiflexion is implemented via a strap over the shoe. The orthoses, size and position of leg cuffs were measured and adjusted to the participant ensuring that walking in the device was as natural and comfortable as possible. Individually tailored levels of body weight support and walking velocity were determined for the Lokomat®. For the present study, the level of guidance force during the Lokomat® training was set to 50%, which allowed for small deviations and required more active patient participation compared to fully guided walking training. At subsequent training sessions, a therapist made individual determinations about adjustments to speed (increases) and BWS (decreases) based on the participant’s performance – with the goal of increasing active participation time (i.e. decreasing rest time) and increasing overall number of steps taken. | PMC10552424 | |
Conventional | Lokomat® | The conventional gait training (CGT) consisted of therapist assisted and/or use of assistive device (walker) for supported walking, if participants were able, or pre-walking exercises (trunk balance, sitting/standing balance, leg movements, etc.) if participants were not able to walk. In general, therapy was progressed with the aim to have participants actively participating for 45 minutes and to maximize steps walked.Treatment was provided by three therapists for the CGT group and a different three for the Lokomat® group. The “regular therapy team” was aware that their patients were involved in a trial (as they could see their patients’ schedule of activities) but were blinded to which of the two arms (Lokomat® or CGT). Paramount to this, the rating team was blinded in the same fashion and that team came from a different unit so there was no possibility for unblinding. Several approaches were used to assess fidelity with which the protocol was implemented. Especially since this was a pilot trial, careful attention was paid in the early stages to ensure key objectives were able to be accomplished. For example, the research coordinator worked diligently to try to ensure all supplemental sessions could be implemented during a busy inpatient schedule and with the normal complement of therapist during regular treatment hours. The therapists were trained by the research staff on the key goals of the supplemental sessions and how to go about achieving them. Consistency of the specific training, beyond the objectives and priorities as outlined in the supplemental material provided, was not enforced as one goal of the study was to implement supplemental | PMC10552424 | |
Outcomes | PMC10552424 | |||
Primary outcome measures | ADVERSE EVENTS | Feasibility of implementation, tolerability, number of training sessions completed, serious adverse events (SAEs). | PMC10552424 | |
Secondary outcome measures | PROM | Functional independence measure (FIM) and FIM efficiency, functional ambulatory category (FAC), passive range of motion (PROM), Modified Ashworth Scale (MAS), 10-meter walk test (10MWT), 2-minute walk test (2MWT), 5 Times Sit to Stand (5x-STS) and the Modified Borg Scale were collected to compare outcomes between the training groups and compared to standard of care only group that was obtained from our database. Participants were allowed to use an assistive device for the test if required. Secondary outcome measures were collected at baseline, at least once every week and at discharge from the IRF stay. | PMC10552424 | |
Statistical analysis | The Wilcoxon signed-rank (WSR) test and effect size (Cohen’s d) were used to compare the within group differences in pre- and post-training on the outcome measures. A Bonferroni correction | PMC10552424 | ||
Discussion | Lokomat, stroke | STROKE, STS | It was feasible and well-tolerated to incorporate an additional three hours per week of gait training therapy into all participants’ schedules over a large portion of their inpatient stay. On average, study participants received 11.3 supplemental therapy sessions (12.8 CGT, 9.8 Lokomat®). It has been noted that other aspects of each individual’s plan of care and stage of recovery can be an obstacle to supplemental therapy [Enrolled participants tolerated additional exercise well. The cardiorespiratory inclusion criteria for study participants biased us to expect this. There was a slight reduction in therapists' perceived exertion in the entire cohort over the course of the study. Neither individual treatment group analysis showed statistical significance given the small group size, the relatively small change (0.7 for each group) and the relatively high variability (1.1 Lokomat®, 2.4 CGT) of that change within each group. The Lokomat® group showed a medium effect size (0.62).Receiving The reference group having higher intake average FIM score can be viewed in two ways. First, having higher function may allow them to achieve more during gait training. Alternatively, the lower the intake score, the more One additional benefit of the supplemental therapy was that both groups showed an Outcome variables linked to functional gains showed the majority of the improvements in both groups. FAC, FIM, 5xSTS, 2MWT, and 10MWT showed large effect sizes (>0.8) in both groups – as well as a trend towards, though not statistically significant, differential effect between groups. FAC and FIM showed average improvements of greater than 1.25 and almost 25, respectively. The average FAC at admission was between 1 and 2, indicating participants required continuous support for weight bearing/balance or intermittent support with balance/coordination during walking. The average score at discharge was just below 3, indicating the requirement of physical support for walking was mostly eliminated. As noted previously, the 5×STS times also improved considerably. There was a notable differential in improvement in STS time between the groups. The Lokomat® group improved by just over 50% (45s at admission vs. 22s at discharge) whereas the CGT group improved by just under 30% (29s at admission to 21s at discharge). We wish to highlight that 9 participants could not complete the STS task at admission and 5 of these could at discharge (see note a). Though these data did not contribute to above reported % changes and statistical analyses, their functional gains were just as important, if not more so, than being able to stand Overall, an important point this work helped to establish is that standard of care plus supplemental therapy can lead to many desired improvements and lack of decline, and this can be done in a fairly efficient manner during the inpatient stay without undue burden on therapist (vis-à-vis reduced RPE scores). Additional studies need to be done to further refine the supplemental protocol, including defining optimal intensity and duration, patient demographics as well as delivery mode. The use of robotics can be an important factor in the practical implementation of supplemental therapy as trying to balance therapist time and physical demands with increasing dosage, timing and scheduling during increasingly shorter inpatient stays can be challenging.Based on the above noted possible differences in effects between treatment groups, we formally explored whether there was a statistical effect of modality. A post-hoc overarching statistical analysis of robotic vs. conventional (CGT) therapy did not show a statistically significant differential effect (MANOVA p=0.21, Pillai Trace). We compared only the interval variables (ankle and knee PROM, 2MWT, 10MWT and 5xSTS) using a single factor MANOVA with post-hoc ANOVAs to compare differences in individual variables. Only these 5 variables were compared since a MANOVA analysis The potential differential effect favoring robotic therapy is particularly striking given that, though not by design, the Lokomat® group received less overall number of supplemental sessions than the CGT group. The Lokomat® training group had approximately 30% fewer sessions per IRF stay, but the stepping intensity of the gait specific training was higher with this device compared to the CGT intervention. This assessment of increased stepping is Recent work, including reviews and meta-analyses of a moderate body of previous work also suggests but does not clearly indicate differential benefits of robotic training for patients in the acute and subacute phases of stroke [ | PMC10552424 |
Limitations | Study participants were inpatients and subject to many constraints, not the least of which is how long they were able to remain on the inpatient unit. As such, some factors could not be controlled as closely as would have been ideal. The sample size was small but appropriate to determine feasibility of providing supplemental therapy during the inpatient stay – which was a primary study objective. The study was not powered to fully explore the extent of differences between the two modalities – which would require a much larger cohort and/or more tightly controlled groups, at least for the current study measures. Post-hoc estimates for study size were n=392 (for each arm, assuming a parity enrollment ratio) for the FIM score changes and standard deviations reported ( | PMC10552424 | ||
Conclusions | PROM, spasticity, stroke, Lokomat, acute stroke | STROKE, ACUTE STROKE | Providing acute stroke patients with additional walking-focused locomotor training is feasible in an IRF environment without undue strain on patient or staff when effort is placed in scheduling such intervention to supplement mandated therapy time. Participants in both intervention groups showed meaningful improvements in most functional outcomes (FAC, FIM, 5xSTS, 2MWT, 10MWT) – compared to their own intake measures (i.e. at the start of their inpatient stay) and a differential improvement in FIM compared to the post-hoc no supplemental therapy group (standard of care). Neither group declined in PROM and spasticity measures. The Lokomat® group showed improvement with fewer number of training sessions but subjectively assessed increased stepping per session. This supports the overall time efficiency of this gait training robotic tool for patients in early stroke rehabilitation. Several functional measures showed practical but not statistical differences between therapy mode. Determining optimal dose of supplemental therapy (of either mode) and whether the Lokomat® group’s progress plateaued or would continue for additional sessions may help to optimize the focus of therapy during this critical phase of acute stroke rehabilitation and should be studied in the future. | PMC10552424 |
Acknowledgements | We are grateful to all the therapist and participants who carried out the efforts to conduct this study. Stella Lee helped with some data organization, an alternate version of statistical analysis and an initial draft of the manuscript. | PMC10552424 | ||
Author contributions | MT performed statistical analyses, wrote the core version of the manuscript and prepared the manuscript for submission; AE conceived the study, oversaw the implementation of the trial and data collection and assisted with editing the manuscript; both reviewed the final manuscript. | PMC10552424 | ||
Funding | None. | PMC10552424 | ||
Availability of data and materials | The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. | PMC10552424 | ||
Declarations | PMC10552424 | |||
Ethics approval and consent to participate | ALBERT | All study participants freely provided informed consent prior to engaging in any study activities; the IRB of Albert Einstein Healthcare Network approved this study (Reference#4949). | PMC10552424 | |
Consent for publication | Not applicable. | PMC10552424 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10552424 | ||
References | PMC10552424 | |||
Background | disability, LBP, Low back pain | Low back pain (LBP) is the leading cause of years lived with disability worldwide. Public safety workers are highly exposed to physically demanding activities and inappropriate postures, increasing the risk of experiencing LBP. Smartphone app-based self-managed interventions may be an alternative for chronic non-specific LBP (CNSLBP) treatment. This study aims to evaluate the effectiveness of a smartphone app-based self-managed exercise program plus health education, compared to a health education program alone, on neuromuscular and perceptual outcomes in police officers and firefighters with CNSLBP. | PMC10693081 | |
Methods | disability, pain | This is a parallel, two-armed, blinded evaluator randomized clinical trial. Police officers and firefighters (from public safety institutions in the Rio Grande do Sul state, Brazil) will be randomly assigned to a m-health self-managed exercise program (twice a week) plus health education or health education alone. Self-management exercise program components are mobility and core resistance exercises, available on the app. Follow-ups will be conducted post-treatment (8 weeks) and 16 weeks after randomization. The co-primary outcomes will be pain intensity and disability post-treatment (8 weeks). Secondary outcomes will be biopsychosocial factors related to CNSLBP. | PMC10693081 | |
Discussion | SECONDARY | We hypothesize that the effects of a smartphone app-based self-managed exercise program on co-primary and secondary outcomes will be superior, compared to the health education only in public safety workers with CNSLBP. | PMC10693081 | |
Trial registration | The study was prospectively registered at ClinicalTrials.gov (NCT05481996. Registered on August 01, 2022). | PMC10693081 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s13063-023-07833-9. | PMC10693081 | ||
Keywords | PMC10693081 | |||
Background | LBP, pain, Low back pain, depression, disability | SECONDARY | Low back pain (LBP) is the leading cause of years lived with disability [Several factors can increase the risk of experiencing LBP, including physical (e.g., regular lifting), psychological (e.g., depression), and poor general health (e.g., sleep problems) [The association between subjective (i.e., pain) and objective measures (i.e., endurance and strength of the trunk muscles) in individuals with CLBP [Therefore, this clinical trial will test the effectiveness of an m-health-based self-managed program based on core strengthening exercises plus health education, compared to an m-health education only, on physical and perceptual outcomes. Considering that several studies demonstrate the effectiveness of health education in the clinical outcomes of patients with CLBP, we choose for an active comparator group intending to reach the principle of equipoise. We hypothesize that the effects of an m-health self-managed program based on core strengthening exercises plus health education will be superior on co-primary and secondary outcomes, compared to education health program. | PMC10693081 |
Methods | PMC10693081 | |||
Protocol elaboration and registration | This study protocol follows the recommendations of the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 Statement [ | PMC10693081 | ||
Study design | This study is a prospectively registered, parallel, two-armed, assessor-blinded, superiority randomized controlled trial. Three assessment points were performed (baseline, 8 weeks post-intervention, and 16 weeks follow-up) with probability sampling with randomization in an allocation ratio 1:1. The planned flow diagram of this trial is presented in Fig. Study design | PMC10693081 | ||
Study setting and eligibility criteria | tumor, Pain, fracture, pain, LBP, NRS | CARDIAC INSUFFICIENCY, TUMOR, CORONARY HEART DISEASE, DISEASES | This trial was conducted until August 2023 at the Inclusion criteria:Aged between 18 and 60 yearsCLBP (defined as pain lasting more than 12 weeks);CLBP of at least three points in a 0 to 10 Pain Numerical Rating Scale (NRS) [Having a smartphone with internet access and an e-mail account;Police officer (federal, federal highway, civil or military) or military firefighter working in the State of Rio Grande do Sul.CLBP was defined as pain or discomfort between the 12th ribs and the lower gluteal folds, with or without symptoms referred to the lower limbs, lasting more than 12 weeks (chronicity), not attributed to a specific diagnosis [Exclusion criteria:Neurological symptoms (nerve root compromise or sensation deficits);Spinal severe diseases (e.g., fracture, tumor, inflammatory, autoimmune, and infectious diseases);Severe cardiovascular and metabolic diseases (e.g., coronary heart disease, cardiac insufficiency, decompensated diabetes);Recent spine surgery (over the last 12 months) or scheduled to undergo surgery in the next 6 months;Pregnancy;History of physical therapy treatment for LBP or physical exercise (strength training for core muscles, Pilates, yoga) current or within the last 3 months;Retired;Having any contraindications to exercise.We pre-screened physical activity participation at baseline using the Physical Activity Readiness Questionnaire (PAR-Q) Portuguese version [ | PMC10693081 |
Data collection and management procedures | PMC10693081 | |||
Pre-intervention assessment | After initial contact with researchers, volunteers were scheduled an interview (through a video call) with one of the assessors where the eligibility criteria for participation in the study was checked. Eligible participants received the online consent form via email (see Additional file The baseline, 8-week, and 16-week online assessments was conducted via video call using a personalized link on the Google Meet platform, and the self-reported data were assessed using the Google Forms platform. All data entries collected by the questionnaire were converted and coded to an Excel spreadsheet (Microsoft Corporation, Redmond, Washington) and double-checked before analysis. The time scheme for study conduction is presented in Fig. Time scheme for study conduction | PMC10693081 | ||
Outcome measures | Anxiety, Pain, Isometric muscular endurance, pain, Depression, disability | SECONDARY, CONTRACTION, DECUBITUS | The co-primary outcomes will be pain intensity and disability at 8 weeks (post-treatment). Pain intensity was measured using the 11-point Pain NRS, a numerical scale where 0 indicates no pain and 10 indicates maximum pain intensity, presenting good levels of test–retest reliability intraclass correlation coefficient (ICC = 0.94) [The secondary outcomes will be as follows:Pain intensity at 16 weeks follow-up;Disability at 16 weeks follow-up;Health-related quality of life at all time points: measured with the WHOQOL-Pain [Self-efficacy at all time points: measured with the Chronic Pain Self-Efficacy Scale [Depression, Anxiety, and Stress at all time points: measured by the Depression Anxiety Stress Scale [Sleep quality at all time points: measured by the Pittsburgh Sleep Quality Index [Work ability at all time points: measured by a single-item question, “Are you working at a physically less demanding job now because of your back and/or leg pain?” [Isometric muscular endurance of the trunk extensor at 8 weeks (post-treatment): measured by the modified Biering-Sorensen test [Isometric muscular endurance of the trunk flexors at 8 weeks (post-treatment): measured by a test that consists of remaining in isometry as long as possible in a sitting position with 45° hip flexion [Maximum isometric strength of the trunk extensor and flexor muscles at 8 weeks (post-treatment): maximum voluntary isometric contraction (MVIC) was measured by a calibrated load cell (Miotec®, Porto Alegre, Brasil) of 200 kgf. For the MVIC test of the trunk flexors muscles, the participants were positioned in a sitting position on top of the stretcher, with knees extended, legs fixed to the stretcher with two traction straps, hips flexed and resting on the backrest of the stretcher adjusted at 30° the surface of the stretcher, and arms crossed in front of the torso. For the MVIC test of the trunk extensor muscles, the participants were positioned in ventral decubitus, with knees extended and legs fixed to the stretcher with traction straps and elbows flexed with hands superimposed on the head. For both tests, the load cell was attached to an adapted stretcher, aligned perpendicularly to the torso, passing through the stretcher’s aperture. Chains connected the load cell to a traction belt positioned at rib height (xiphoid process). Participants performed three 5-s attempts for each position, with a 2-min interval between each attempt. During the tests, participants were verbally encouraged to apply maximum force as quickly as possible. The cell load values (kgf) were transformed into Newton (N) and multiplied by the distance (m) between the hip joint (greater trochanter of the femur) and the point of attachment of the traction belt to calculate peak torque in N.m;Muscular activation of spine flexor and extensor muscles at 8 weeks (post-treatment): simultaneously with the MVIC collection, the neuromuscular activation of the trunk flexor (rectus abdominis) and extensors (erector spinae—longissimus) muscles was measured using the surface electromyography technique (sEMG). A Miotool device (Miotec®, Porto Alegre, Brazil) was used with 1 cm Ag/AgCl electrodes (Meditrace®, Mansfield, Canada) and an interelectrode distance of 30 mm. The sEMG signal was collected from the right side of the participant’s body. During the assessments, the recommendations of skin preparation, asepsis, and fixation of the SENIAM electrodes were observed [Occupational performance at 8 weeks (post-treatment): measured by a task that simulates a victim rescue. The participant will drag a dummy (weight = 60 kg) away from the start line, around a cone placed at the 13 m mark, and return to the start line. The longer the time indicates worse occupational performance.Eligible participants were randomly allocated to the intervention or control group with a 1:1 simple allocation using a computer-generated randomization sequence created by a blinded investigator via a random function in Excel software for Windows. After randomization, an independent researcher emailed each participant the login and password to access the specific app version to which they were allocated (intervention or control). Afterward, an assistant researcher inserted them into numbered, sealed, and opaque envelopes. | PMC10693081 |
Blinding | Due to the intervention’s characteristics, blinding of participants and intervention providers was not possible. The outcome assessors were blinded to the treatment groups. Participants are asked to omit their assigned group and not discuss their interventions during the outcome assessments. In unblinding cases, the principal investigator was notified with the participant ID, date, and reasons for unblinding. | PMC10693081 | ||
Interventions | Intervention descriptions followed the TIDieR (Template for the Intervention Description and Replication) checklist recommendations for telehealth interventions used in clinical trials [ | PMC10693081 | ||
Intervention group: m-health-based pain education and exercise | chronic pain, pain | CHRONIC PAIN | Patients allocated to the experimental group received a login and password for individual access to the smartphone app (The exercise component (app “training” function) included 8 weeks of training, with two sessions per week (non-consecutive days) of core strengthening exercises. The exercise program was developed by exercise professionals with at least 5 years of clinical experience, specialists in chronic pain treatment, and who used exercise-based treatment. The training periodization followed the progression of pre-established protocols for CLBP treatment reported in the literature (see training periodization in Additional file The app provided animated Graphics Interchange Format (GIFs), descriptions, and audio of how to perform each exercise. The number of repetitions or time under tension for each exercise were prescribed with a range of target zones (e.g., 10–12 repetitions, 20–30 s). For those who cannot reach these zones, they were asked to indicate (on the app) that they could not perform the complete exercise. Exercise sessions were carried out remotely and self-managed by the participant (i.e., the participants were responsible for carrying out the exercises). The content of the training sessions was made available (visible in the app version) each week of intervention training.The message component from the app provided 8 messages (one per week), with the contents taken from the online booklet. Messages included information about the benefits of exercise, motivation, and positive messages about coping with pain.The online booklet contained general information about self-management of chronic pain, including pain education, advice on healthy lifestyle and sleeping habits, and promotion of exercises. The “Contact” function from the app provided participants a direct communication with the researcher to answer questions about the app, its features, and information about possible app errors. In addition, to improve training adherence, the app provided a count and progression bar (%) of the number of completed training days. Adherence was defined as the absolute and relative frequency of the number of sessions performed. | PMC10693081 |
Control group: m-health-booklet and pain education | pain | Patients allocated to the control group received a login and password for individual access to the smartphone app designed for the study. The app content for this group included two components: (1) an online booklet and (2) weekly messages. The online booklet contained general information about self-management of CLBP, including pain education, advice on healthy lifestyle and sleeping habits, and promotion of physical activities based on the “Back Book” (see Additional file The message component provided 8 messages (one per week), with their contents taken from the online booklet. Messages included information about the benefits of exercise, motivation, and positive messages about coping with pain. Before intervention begins, participants received a yoga mat, an elastic band, and a link to a video tutorial on how to use the app. To increase adherence to the intervention, after the study is concluded, the training function available in the app will be offered to the control group participants if the intervention group proved to be more effective than the control group. | PMC10693081 | |
Strategies for trial retention | Participants allocated to both groups received, in week 4, WhatsApp messages to reinforce the use of the app. There are prohibited concomitant interventions including any systematic or supervised physical exercise to strengthen core (e. g., Pilates, Yoga). Any exercise should be reported by the participants and documented for future discussions. | PMC10693081 | ||
Statistical methods | PMC10693081 | |||
Sample size calculation | Sample size estimation was performed a priori through G-Power’s statistical software (version 3) [ | PMC10693081 | ||
Data analysis | The baseline characteristics of the participants were calculated using descriptive statistics. The between-group differences and 95% confidence interval (95%IC) for the post-treatment outcomes at 8 weeks and 16 weeks follow-up were calculated using linear mixed models using interaction terms of treatment group versus time. An intention-to-treat approach will be used in all statistical analyses. Per-protocol analyzes will also be performed, including only participants from the experimental group arm who adhere to the intervention (i.e., having performed at least 12 of the 16 training sessions). For the intention-to-treat analyses, the incomplete data (i.e., missing values) were estimated using multiple data imputation techniques through statistical software. All statistical analyzes will be performed using the SPSS statistical software (Statistical Package Social Science), version 20.0 for Windows (IBM corporation, Somers, New York, USA). | PMC10693081 | ||
Monitoring | PMC10693081 | |||
Data monitoring and auditing | The study does not have a data monitoring committee either planned auditing trial conduct due to limited resources. We believe this committee would not be mandatory due to the characteristics of interventions and outcomes despite its high value for the overall trial quality. Interim analyses will not be conducted in this trial. | PMC10693081 | ||
Harms, ancillary, and post-trial care | ADVERSE EVENTS | The adverse events were collected by weekly recording the number of adverse events throughout the intervention period. A closed-ended question with two options (yes or no) sent by the app at the end of each week: “During the last week of the study, did you present any different symptoms or worsening of the initial condition?”. Also, in case of a positive answer, a second closed question was asked: “Do you think this symptom or worsening of the initial condition was generated by the treatment provided in this study?”.At least two researchers discuss all adverse events: the main researcher (EFM), the study manager (CLA), and medical consultants and experts if necessary. If the treatment is causing the participant to deteriorate, a video call is offered with one of the study physiotherapists to evaluate the issue or suggest discontinuation of the treatment for the participant.In the case of the proven effectiveness of the exercises provided by the app in managing CLBP, access to the effective app version for participants in the control group after the end of the study period was provided. | PMC10693081 | |
Dissemination policy | EVENT | After completing the study, we aim to disseminate the results to as many stakeholders as possible. First, participants will receive their reports with their measurements and interpretations in language adapted to the lay public’s understanding. The main findings, whether positive, negative, or inconclusive, will be disclosed directly or at an event aimed at managers of public security organizations through the exhibition/presentation of a structured summary (infographic) and submitted to a peer-reviewed international journal for possible publication. All information regarding the full protocol, participant-level dataset, and statistical code will be available from the corresponding author upon reasonable request. | PMC10693081 | |
Discussion | pain | This randomized control trial will investigate a new model of care to treat a highly prevalent and disabling problem in public safety workers, such as police and firefighters. We hypothesize that the m-health-based telerehabilitation program will benefit public safety workers with CLBP by reducing pain intensity and improving function and psychological, behavioral, and neuromuscular outcomes compared to a mobile minimal intervention approach (booklet).The app is based on relatively simple interventions (i.e., remote-based exercise and pain education). This app was designed to be simple and have easy implementation in the worker health settings of public safety institutions. Some public safety institutions do not have, or only provide, in-person hospital care in a single location. Thus, the app developed will be able to expand care and potentially change the lives of millions of police officers and firefighters with CLBP that have limited access to face-to-face care.In case of our hypothesis being confirmed, we can contribute to the discussion of a new treatment modality (i.e., m-health-based telerehabilitation program) for this population. The results may have practical applications to public security organizations that implement this therapeutic modality in CLBP treatment and may imply the reduction of absenteeism and presenteeism of these professionals, with a positive impact on the service provided to society. | PMC10693081 | |
Trial status | MAY, RECRUITMENT | The recruitment period for this study occurred from October 2022 to May 2023. This is the first version of the manuscript and is accompanied by a description of existing amendments (see Additional file | PMC10693081 | |
Acknowledgements | Not applicable. | PMC10693081 | ||
Authors’ contributions | DM, TTP | TTP | CLA, EFM, and FBDV designed the study and wrote down the specific aspects of patient-reported outcomes. CLA, EFM, ELC, and FBDV conceptualized the study design. CLA, EFM, ELC, FBDV, and TTP reviewed and edited the draft writing. DM, FS, and TTP developed and supported the application that will be used in this trial. CLA, EFM, FBDV, and VK developed the exercise component of the intervention. EFM and CLA will supervise the overall project, and TTP will manage the application-related part of the trial. All authors contributed to improving the study protocol and read and approved the final manuscript. | PMC10693081 |
Funding | The authors of this trial declare that they do not have specific assistance for this research from any funding agency in public, commercial, or non-profit sectors. The principal investigator and the study’s assistant investigators will provide the materials used in this clinical trial. Educational support, such as the availability of equipment and consumables, will be provided by the Physical Education School of the Federal University of Pelotas.Involved personnel has been founded by CNPq (Conselho Nacional de Desenvolvimento Científico e Tecnológico), Brazil, grant number 315430/2021–4 (CLA), and financed in part by the CAPES (Coordenacão de Aperfeiçoamento de Pessoal de Nível Superior, finance code 001(ELC and DMJ). | PMC10693081 | ||
Availability of data and materials | EVENTS | All data will be used only for analysis of the present study and will be protected from unnecessary exposure. According to the Research Ethics Committee of Physical Education School, the authors and patients will sign the consent form. The paper information will be kept in binders and handled only by the researchers responsible for the study in locations accessible only to researchers responsible for data analysis. The online information will be in a database maintained on a server, to which only the researcher responsible for the project will have access. All information will be published confidentially without the name of the participants exposed. All data will be available for review and confirmation of data analysis when requested by a review process for publication of the article in indexed scientific journals or presentations at scientific events. The data will be available from the corresponding author upon reasonable request. | PMC10693081 | |
Declarations | PMC10693081 | |||
Ethics approval and consent to participate | This study was approved by the Research Ethics Committee from | PMC10693081 | ||
Consent for publication | Not applicable. | PMC10693081 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10693081 | ||
References | PMC10693081 | |||
Background/aim | Authors widely use pulse oximetry in clinical monitoring of heart rate (HR) and peripheral oxygen saturation (SpO | PMC10388062 | ||
Materials and methods | burns | We designed a prospective comparative study in a training and research hospital. After local ethical committee approval, pediatric male cases eligible for penile and extremity pulse measurements were evaluated during general anesthesia for medical dressing and/or grafting due to severe burns. One probe was attached to the fingers of the unburned extremity, and the other was to the penile shaft. Furthermore, we recorded SpO | PMC10388062 | |
Results | Data of 51 patients (median age, 2.9 years (interquartile range, 2.0–5.0 years)) in whom the duration of dressing was at least 15 min were analyzed. There was no significant difference either in comparisons of hemodynamic measurements (HR and SpO | PMC10388062 | ||
Conclusion | This clinical trial demonstrated that pulse oximetry measurement under nonhypoxic conditions we could perform confidently using penile probes in pediatric male patients whose extremities are unavailable for measurement. | PMC10388062 | ||
1. Introduction | ’ arterial blood, trauma | PENIS | Arterial blood oxygen saturation (SaO2) has clinical and physiological importance. It is a parameter we must closely monitor in many patients as a direct indicator of oxygen supply to the organs and tissues. SaO2 level can be determined noninvasively by pulse oximetry; this measurement, defined as peripheral oxygen saturation SpOConsequently, intensive care unit admissions might decrease. It may reduce patients’ arterial blood sampling by allowing noninvasive monitoring [Pulse oximeter sensors are usually attached to the fingers; however, there is a need for an alternative site for the sensors to be connected. If peripheral perfusion is inadequate or the usual extremities for pulse oximetry measurement are unavailable, especially in trauma involving extremity injuries, finding a good body side to place pulse oximetry might be difficult. There could be a problem with a body area where a safe pulse oximetry probe can be placed.The present study aimed to investigate the availability of a pulse oximeter probe attached to the penile shaft as an alternative site in male patients. In the literature, a study on burned children evaluating an alternative pulse oximetry side like a penis is not present. However, in practice, anesthesia staff can deal with a patient with four extremity injuries. This study will help anesthetists remodel their practice for these patients. Assuming that extremities became unavailable for pulse oximetry measurement, burned patients were evaluated for their availability at a different measurement site, especially by a penile shaft. | PMC10388062 |
2. Materials and methods | burn injury, cardiovascular diseases, burn injuries, burns, ’ extremities | ONCOLOGY, PENIS, DISEASE, CARDIOVASCULAR DISEASES | Clinical Research Ethics Committee of Ankara Child Health and Disease, Hematology, Oncology Training, and Research Hospital, Ankara, Turkey (Chairperson Prof. Fatma Demirel) on 01 June 2015 (Approval number: 2015–025) approved the present study. The study was conducted in Ankara Child Health and Disease, Hematology, Oncology Training, and Research Hospital, Ankara, Turkey. Informed consent of the patients or the legal guardians was also obtained. The study was conducted between September 2015 and March 2017.Pediatric male cases undergoing general anesthesia for medical dressing and/or grafting due to severe burns were involved in the study. We included patients on the condition that the fingers of at least one extremity were not involved in burn injury or a surgical procedure. Exclusion criteria were only performed for burned children with cardiovascular diseases as pulse oximetry measurements were compared within the patients’ extremities and penis. Possible differences in pulse measurements between these locations are taken into account. However, we had no cardiovascular patients with burn injuries.Monitoring via pulse oximetry measurement was initiated as soon as the patients were placed on the operating table. Monitoring was performed using two pulse oximetry devices with the same brand and model (Nellcor N-560 Pulse Oximeter Monitor, Mansfield, USA). Moreover, two disposable oximeter probes (OxiMax Technology Max-N-Infant/Adult SpO | PMC10388062 |
2.1. Statistical analysis | Data analysis was performed using MedCalc version 11.1.1.0 (MedCalc Software, Mariakerke, Belgium). Where appropriate, data were expressed as mean± SD or median (interquartile range [IQR]). The mean differences in hemodynamic measurements (i.e. HR and SpO | PMC10388062 | ||
3. Results | burns | The study included 56 male pediatric patients with severe burns. There were no race or ethnicity differences. As the medical dressing lasted for 5 min in 2 cases and 10 min in 3 cases, these cases were excluded, and thereby data of 51 patients in whom the duration of dressing was at least 15 min were analyzed. These 51 patients had a median age of 2.9 years (IQR, 2.0–5.0 years) and a median body weight of 15 kg (IQR, 12.0–21.0 kg). Of these 51 patients, 38 had a dressing duration of 20 min. At the 0th minute lowest value of SpOIn 51 patients, there was no significant difference either in comparisons of hemodynamic measurements (HR and SpONo significant differences were determined between the percentage changes of HR measurements obtained by finger probe and penile probe at the baseline›s 5th, 10th, and 15th minutes. Likewise, there were no significant differences between the percentage changes of SpOThe results of the Bland-Altman plot analysis performed to assess the agreement between the penile and finger probes for the measurements of HR and SpO | PMC10388062 | |
4. Discussion | trauma | PENIS, EVENT | In this study, we aimed to evaluate an alternative side of monitoring to follow up oxygen saturation in certain conditions. Having pulse oximetry results on the extremities might be a problem for burned children. Although the possibility of this situation is slight, it is not negligible. There for, we evaluate the penile shaft as a possible alternative side of monitoring. As hypothesized, the penis could be an alternative side of pulse monitoring if circumstances for limbs are unavailable.In many clinical practices, pulse oximetry measurement is used for monitoring HR and SpOIn studies with earlobes, it has been determined that pulse oximetry values are more accurate than finger and toe measurements [Robertson and Kaplan reported the penile shaft as a good site for a pulse oximeter probe [In the present study, we investigated the availability of a pulse oximeter probe attached to the penile shaft in the event extremities were unavailable. Evaluation of the agreement between the measurements performed by each probe using Bland-Altman plot analysis revealed the mean bias value in 51 patients. Accordingly, based on the acceptable degree of bias and limits of agreement, we could conclude that the oximeter probe can be attached to the penile shaft when necessary. In a multicenter, observational study conducted on children, arterial blood SaO2 values were compared with pulse oximetry SpOIn the present study, the absence of comparison with arterial blood sample levels could be regarded as a limitation; nevertheless, in light of the data mentioned above, the comparisons could be considered to have acceptable accuracy since all SpOIn conclusion, we suggest that pulse oximetry measurements during a medical emergency, intensive care services management, and peroperative period could be performed using penile probes in pediatric male patients whose extremities are unavailable for measurement in cases like trauma. | PMC10388062 |
Acknowledgment | ONCOLOGY, DISEASE | This research did not receive any specific grant or funding from funding agencies in the public, commercial, or not-for-profit sectors.
The authors declare that they have no conflict of interest.
Clinical Research Ethics Committee of Ankara Child Health and Disease, Hematology, Oncology Training, and Research Hospital, Ankara, Türkiye (Chairperson Prof. Fatma Demirel) on 01 June 2015 (Approval number: 2015-025) approved the present study. | PMC10388062 | |
References | HEART | Bland-Altman plot showing the magnitude of the difference between heart rate (HR) obtained by penile and finger probes (n = 51). Heart rates unit is beat /minute. Solid lines indicate mean bias and dashed lines indicate the lower and upper limits of agreement. A: 0th (baseline) minute, B: 5th minute, C: 10th minute, and D: 15th minute.Bland-Altman plot showing the magnitude of the difference between oxygen saturation (SpOPulse oximetry measurements using finger and penile probes in the course of dressing.Data are presented as mean ± standard deviation.Paired samples t-test; comparisons of hemodynamic measurements obtained by finger probe and by penile probe for each measurement time.Repeated measurements of ANOVA by Wilks’ lambda test; comparisons of hemodynamic measurements among measurement times for finger or penile probe.Percentage differences in pulse oximetry measurements at the 5th, 10th, and 15th minutes with respect to baseline.Data are presented as interquartile range.Wilcoxon signed-rank test; comparisons of percentage changes of hemodynamic measurements obtained by finger probe and by penile probe at the 5th, 10th, and 15th minutes with respect to baseline.Results of Bland-Altman analysis (n = 51).Bias, differences between penile and finger probe measurements; SD, standard deviation; LL, lower limit; UL, upper limit. | PMC10388062 | |
1. Introduction | weight gain, txt4two | txt4two is a multi-modality intervention promoting healthy pregnancy nutrition, physical activity (PA), and gestational weight gain (GWG), which had been previously evaluated in a pilot randomized controlled trial (RCT). This study aimed to evaluate a pragmatic implementation of an adapted version of txt4two in a public tertiary hospital. Using a consecutive cohort design, txt4two was delivered to women with a pre-pregnancy BMI > 25 kg/mSuboptimal antenatal health behaviors, including diet quality and physical activity, and excess gestational weight gain (GWG) are associated with negative pregnancy-related and long-term health outcomes for both the mother and offspring. These include the increased risk of caesarean sections [In Queensland, Australia, between 30% to 100% of women (depending on their body mass index (BMI) category) gain more weight than recommended during pregnancy [A recent systematic review and meta-analysis noted that weighing, as a stand-alone intervention, does not reduce excess GWG [Since the opening of the new Mater Mothers’ Hospital (MMH) in Queensland, Australia, in 2008, a number of service delivery initiatives have been developed, implemented, and evaluated to meet the identified nutrition needs of women attending the service [The next service priority for the MMH was the development of personally tailored strategies to support women to improve diet quality and decrease excess GWG. This priority is to be realized through exploring the potential of broad reach/low intensity methods of delivery, such as digital health approaches. When these approaches are embedded in maternity service, they can offer the opportunity for tailored messages that provide information and resources to facilitate knowledge acquisition and behavior change. This approach may help to clarify the complexity women experience from the ‘noise’ of social media and traditional media by offering evidence-based messages from trusted health services in more accessible modalities [The program to be adopted and adapted is the txt4two program [The aim of this current study was to evaluate the pragmatic implementation of an adapted and site-specific version of the txt4two program into the MMH antenatal nutrition and dietetic service. The outcomes provide further understanding of implementing an intervention in a system with a different service infrastructure to the original research context [ | PMC9921852 | |
2. Materials and Methods | PMC9921852 | |||
2.1. Study Design | This study followed a consecutive cohort design. It was a prospective, pragmatic implementation and evaluation informed by the RE-AIM framework [ | PMC9921852 | ||
2.2. Participants and Recruitment | RECRUITMENT | This study was delivered through the Brisbane MMH antenatal clinic across 2019–2020. Eligible women were women who entered pregnancy with a BMI ≥ 25 kg/mEligible women were identified through numerous channels, i.e., the MMH online registration form completed by some women attending the publicly-funded antenatal services, recruitment advertisements in the MMH antenatal clinic and/or social media accounts (Instagram and Facebook), invitation by antenatal health professionals (dietitian, obstetrician, and midwife), a link provided on the Mater Research Institute’s clinical trials site, and direct SMS invitation to participate during the hospital registration process. An initial prospective control (PC) group who received usual care (advertised as the ‘Healthy Living in Pregnancy’ survey for interest, HLIP) was planned to be recruited (n = 150). Following this, it was planned that women (n = 150) would be recruited into the txt4two intervention. Following consent, details were then provided to administrative services to book women into the MMH dietitian’s antenatal clinic. Women who chose not to participate in the txt4two program received antenatal care, including dietetics referrals and reviews, as clinically appropriate. | PMC9921852 | |
2.3. Sample Size | weight gain | Based on detecting the ~2 kg between group difference (+4.3) in weight gain from the pilot RCT [ | PMC9921852 | |
2.4. Intervention—The txt4two Program | The txt4two intervention was delivered from baseline (i.e., between 10 + 0 and 17 + 6 weeks) to 36-weeks’ gestation and consisted of a tailored suite of theoretically grounded, evidence-based intervention strategies focusing on promoting healthy nutrition, physical activity, and GWG. Intervention modalities included: bi-directional text messages (SMS) promoting positive health behaviors, goal setting and self-monitoring, video messages, and an information website.The txt4two intervention content was developed according to evidence-based guidelines. The Institute of Medicine GWG guidelines [The process of adapting and embedding the program into the MMH service commenced with system-level work to identify key representatives and systems to involve in stakeholder engagement and ensure ownership and suitability for the local site. The adaptation of the txt4two model was systematically planned with a proactive process of modification to fit the intervention into the MMH context and enhance its feasibility and acceptability [Following the introductory session (which included goal setting around nutrition and physical activity habits that could be changed every six weeks), intervention participants received four to five individually tailored interactive SMS per week. The SMS delivered information specific to the individual’s gestational week, encouragement of positive health behaviors, monitoring of individual goals, and encouragement of self-monitoring of GWG. Original texts developed and mapped according to the behaviour change techniques by the authors J.W. and B.F., and they were adapted by S.W. through wide stakeholder consultation. Women chose the frequency of texts that aimed to: prompt review of their weight (weekly or fortnightly) and check their behavioral goals (weekly or fortnightly). SMS receipt was confirmed by telephone early in the intervention. As with the previous study, the SMS were bi-directional, allowing women to provide feedback on their goal progress and/or weight, triggering different pre-programmed responses of positive reinforcement or encouragement.A study-specific website outlined intervention content information ( | PMC9921852 | ||
2.5. Compensation | Women recruited to the control arm of the study were invited to enter the draw to win one of three Mater Mothers’ product gift packs (AUD 31.98 RRP) at the completion of the baseline and follow-up surveys. Women from the intervention arm were offered the chance to go into the draw to receive one of three AUD 50 department store gift cards on completion of each survey. | PMC9921852 | ||
2.6. Outcome Measures and Data Analysis | RECRUITMENT | To meet the project aims, a comprehensive evaluation, based on the RE-AIM model, was planned [Implementation/Adoption: Barriers and facilitators to embedding the program into existing services for delivery were interrogated, with examination of study records for timelines and MMH system interactions. Further, senior author (JW) led a discussion with the project team about the facilitators and barriers to the adoption of a digital program within the MMH systems. These discussion data were analyzed thematically. Reach: The proportion of women willing to take part in the txt4two program and their representativeness, compared to the broader MMH population. A comparison of the study population’s demographics and anthropometrics (age, education level, and ppBMI) was compared with the wider MMH public-hospital population during the study period. Participation rates were also calculated from MMH activity data during the study period. Effectiveness: In changing appropriate maternal GWG, fruit and vegetable intake and diet quality, and changing physical activity levels, as measured for women enrolled in the txt4two intervention, compared with: (a) the prospective control group who did not to receive txt4two (as the program was not implemented in the clinic when the women were recruited), but completed two surveys, and (b) between modalities of the introductory session of the txt4two program (i.e., F2F, Group F2F, or telehealth). All women were sent a URL via text message to a survey hosted by Survey Monkey at baseline and 36 weeks’ gestation. The survey requested socio-demographic, (age, education, income, aboriginal and/or Torres Strait Islander status), pregnancy, and anthropometric characteristics and dietary quality and physical activity via valid questionnaires. Women were asked their height, pre-pregnancy weight, current weight, and weeks of pregnancy in the baseline survey and current weight and weeks of pregnancy at the follow-up survey. Women in the txt4two group also answered questions about their program experience in the follow-up survey. Dietary quality was assessed with the fat and fiber behaviour questionnaire (FFBQ) [Physical activity was assessed using pregnancy physical activity questionnaire (PPAQ) [Women’s engagement with the program, including preference for initial modality and uptake of, retention in, and engagement with the program. Preference for initial goal-setting modality (dietetic F2F, dietetic led workshop/HSP, dietetic telehealth); recruitment (women engaged in program/women offered enrolment) was recorded by the program manager via survey and project database. | PMC9921852 | |
2.7. Analysis | Quantitative data were analyzed with IBM SPSS Statistics v28 (Armonk, NY, USA: IBM Corp). Means and standard deviations (normal distributions), medians and interquartile ranges (IQR) (skewed distributions), or frequencies were calculated. The 2009 IOM GWG guidelines [ | PMC9921852 | ||
3. Results | PMC9921852 | |||
3.1. Implementation/Adoption | RECRUITMENT | The program implementation commenced in February 2018 and took two years, as it was impacted by the complexities of navigating the hospital systems and by the COVID-19 pandemic. The adaption and adoption process required many iterations of recruitment processes and program delivery due to extensive consultation and navigation of interdependent, but unaligned, hospital systems. This included an extensive ‘review and approval’ process. This involved the expected reviews by Ethics and Governance committees, as well as information and communications technology governance (for agreement regarding website hosting, text message delivery and recruitment), management and clinicians of obstetrics, midwifery, dietetics, physiotherapy, and pregnant women (regarding content approval and updates required and program delivery), mater education (for program content), hospital marketing (for brand alignment, production of locally branded content, promotion of the research, and the txt4two program, recruitment), and research marketing (for brand alignment, branded content, promotion of the research and the txt4two program, recruitment), legal services (due to the research collaboration between interstate collaborators), and administration service (for booking and for recruitment processes). Often, negotiations with one department resulted in additional approval from other departments (management, marketing), with multiple ethics amendments required.The project team identified enablers for the program adoption. The health service (management, clinicians, and women) embraced digital disruption, and this was viewed as an enabler because digital education resources for women and families had already been developed. The project being led by an embedded research dietitian, who worked across the clinical domain, was seen to facilitate the evidence-based adoption and allow for early, wide (and persistent) stakeholder engagement with an understanding of hospital systems. The robust implementation and co-creation plan provided a road map for implementation that was seen as a facilitator, along with the decision to be flexible and pragmatic, allowing for adaptability, when required, to fit with stakeholders and infrastructure. Barriers to adoption were also identified. Significant negotiations that elongated timeframes included legal agreements and intellectual property ownership and transaction across institutions and between individuals. Tailoring the content for the requirements of individual health professionals and marketing and ethics required more negotiation than expected. Navigating technology infrastructure was more complicated than anticipated. For example, gaining approval to use the system to go live took nine months, due to information technology delays and the integration being deemed a low priority. Through discussions, it was initially believed that this online process aligned with the hospital’s online intake form; however, this was later identified as being a separate process, unable to incorporate study registration, due to its own implementation trial. | PMC9921852 | |
3.2. Reach | RECRUITMENT, RECRUITMENT | Recruitment for the prospective control group ran for nine months (29 July 2019–27 April 2020) and for six months for txt4two (8 April 2020–19 October 2020), rather than the planned three months for each. Additional recruitment strategies were added during the study, in response to slow enrolment rates. Women were initially recruited via posts on the hospital’s social media accounts (Facebook, Instagram), flyers within the antenatal clinic, and via the hospital’s online registration form. An invitation text message to all eligible women registering with the hospital was introduced in June 2020. The number of women who registered their interest and the eligible proportions who completed each survey (and the program) are shown in During the study period, of the 7172 public-hospital women receiving antenatal care at the study hospital, 2100 women had a ppBMI > 25 kg/mThe initial plan was to recruit three groups of 50 women, in order to test the different modalities of the txt4two introductory session, but this was not possible, due to the COVID-19 global pandemic. The majority of intervention group participants received their preferred modality for the introductory session, choosing telehealth delivery. However, the pivot to all care being delivered via telehealth, due to COVID-19, precluded any F2F delivery. (The majority of women in the txt4two group nominated telehealth as their preferred modality for the introductory session (73.3%; n = 22), with 16.7% (n = 5) of women nominating F2F delivery as their first preference, and 10.07% (n = 3) of women selected the Group F2F as their third preference). | PMC9921852 | |
3.3. Effectiveness | PMC9921852 | |||
3.3.1. Engagement and Acceptability | Program engagement experiences are outlined in | PMC9921852 | ||
3.3.2. Gestational Weight Gain | As shown in | PMC9921852 |
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