Telehealth Movement-to-Music With Arm-Based Sprint-Intensity Interval Training to Improve Cardiometabolic Health and Cardiorespiratory Fitness in Children With Cerebral Palsy: Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: Children with mobility disabilities, including those with cerebral palsy, have limited options and limited time to exercise to manage their cardiometabolic health and cardiorespiratory fitness. Regular cardiovascular exercise during childhood is a critical health behavior for preventing health decline in adulthood. Thus, there is an urgent need for accessible, age-appropriate, convenient exercise modalities in this group. Sprint-intensity interval training (SIT), combined with telehealth procedures, may be ideal for children with disabilities. SIT includes repetitive bouts of maximal exercise effort combined with rest periods, which can be effective in eliciting comparable results to moderate-exercise training with very short training durations. OBJECTIVE: This phase 1 pilot feasibility randomized controlled trial aims to investigate the potential effects of a 12-week SIT program on indicators of cardiorespiratory fitness and cardiometabolic health among children with cerebral palsy. An ancillary aim is to evaluate the feasibility of the program through several process feasibility metrics. METHODS: This study uses a 2-armed parallel group design. A total of 50 physically inactive children with cerebral palsy (aged 6-17 years) will be randomly allocated into 1 of 2 groups: a 12-week SIT or a waitlist control group that continues habitual activity for 12 weeks. The SIT prescription includes 3 tele-supervised sessions per week with 30 repeated sequences of 4 seconds of maximal arm exercise, with active recovery, warm-up, and cooldown periods (for an approximately 20-minute total session). SIT includes guided videos with child-themed arm routines and music. The exercise sessions will be remotely supervised through a web-based videoconference application and include safety monitoring equipment. Outcomes are measured at pre- and postintervention (weeks 0 and 13, respectively). Health outcome measures include peak oxygen consumption (VO2 peak), measured by a graded exercise test; high-sensitivity C-reactive protein and blood insulin, hemoglobin A1c, triglycerides, and cholesterol using a finger stick dried blood spot test; blood pressure, using a sphygmomanometer; and body composition (total mass, total lean mass, tissue % lean, and tissue % fat) using dual x-ray absorptiometry. Feasibility will be evaluated by the following metrics: adverse events or problems experienced throughout the intervention related to participant safety; perceived enjoyment; and recruitment, enrollment, and attrition rates. RESULTS: Recruitment procedures started in November 2023. All data are anticipated to be collected by February 2025. Full trial results are anticipated to be analyzed and submitted for publication by March 2025. Secondary analyses of data will be subsequently published. CONCLUSIONS: This trial tests an accessible and low-cost exercise program that leverages principles of high-intensity exercise to provide a convenient program for children with physical disabilities. Knowledge obtained from this study will inform the development of a larger trial for improving the cardiometabolic health, cardiorespiratory fitness, and well-being of children with physical disabilities. TRIAL REGISTRATION: ClinicalTrials.gov NCT05619211; https://clinicaltrials.gov/study/NCT05619211. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/56499.

Validity and Reliability of a Telehealth Physical Fitness and Functional Assessment Battery for Ambulatory Youth With and Without Mobility Disabilities: Observational Measurement Study.

BACKGROUND: Youth (age 15-24 years) with and without disability are not adequately represented enough in exercise research due to a lack of time and transportation. These barriers can be overcome by including accessible web-based assessments that eliminate the need for on-site visitations. There is no simple, low-cost, and psychometrically sound compilation of measures for physical fitness and function that can be applied to youth with and without mobility disabilities. OBJECTIVE: The first purpose was to determine the statistical level of agreement of 4 web-modified clinical assessments with how they are typically conducted in person at a laboratory (convergent validity). The second purpose was to determine the level of agreement between a novice and an expert rater (interrater reliability). The third purpose was to explore the feasibility of implementing the assessments via 2 metrics: safety and duration. METHODS: The study enrolled 19 ambulatory youth: 9 (47%) with cerebral palsy with various mobility disabilities from a children's hospital and 10 (53%) without disabilities from a university student population. Participants performed a battery of tests via videoconferencing and in person. The test condition (teleassessment and in person) order was randomized. The battery consisted of the hand grip strength test with a dynamometer, the five times sit-to-stand test (FTST), the timed up-and-go (TUG) test, and the 6-minute walk test (6MWT) either around a standard circular track (in person) or around a smaller home-modified track (teleassessment version, home-modified 6-minute walk test [HM6MWT]). Statistical analyses included descriptive data, intraclass correlation coefficients (ICCs), and Bland-Altman plots. RESULTS: The mean time to complete the in-person assessment was 16.9 (SD 4.8) minutes and the teleassessment was 21.1 (SD 5.9) minutes. No falls, injuries, or adverse events occurred. Excellent convergent validity was shown for telemeasured hand grip strength (right ICC=0.96, left ICC=0.98, P<.001) and the TUG test (ICC=0.92, P=.01). The FTST demonstrated good agreement (ICC=0.95, 95% CI 0.79-0.98; P=.01). The HM6MWT demonstrated poor absolute agreement with the 6MWT. However, further exploratory analysis revealed a strong positive correlation between the tests (r=0.83, P<.001). The interrater reliability was excellent for all tests (all ICCs>0.9, P<.05). CONCLUSIONS: This study suggests that videoconference assessments are convenient and useful measures of fitness and function among youth with and without disabilities. This paper presents operationalized teleassessment procedures that can be replicated by health professionals to produce valid and reliable measurements. This study is a first step toward developing teleassessments that can bypass the need for on-site data collection visitations for this age group. Further research is needed to identify psychometrically sound teleassessment procedures, particularly for measures of cardiorespiratory endurance or walking ability.

Improving Social Isolation and Loneliness Among Adolescents With Physical Disabilities Through Group-Based Virtual Reality Gaming: Feasibility Pre-Post Trial Study.

BACKGROUND: Adolescents with disabilities experience alarmingly higher rates of depression and isolation than peers without disabilities. There is a need to identify interventions that can improve mental health and isolation among this underserved population. Innovations in virtual reality (VR) gaming "standalone" headsets allow greater access to immersive high-quality digital experiences, due to their relatively low cost. OBJECTIVE: This study had three purposes, which were to (1) examine the preliminary effects of a low-cost, home-based VR multiplayer recreation and socialization on depression, socialization, and loneliness; (2) quantify the acceptability of the program as measured by participant adherence, total play time, and exercise time; and (3) identify and describe behavioral mechanisms that affected participant engagement. METHODS: This was a single-group, pre- to postdesign trial. The intervention was conducted at home. Participants were recruited from a children's hospital. The intervention lasted 4 weeks and included 2×1-hour sessions per week of supervised peer-to-peer gaming. Participants used the Meta Quest 2 headset to meet peers and 2 coaches in a private party held digitally. Aim 1 was evaluated with the Children's Depression Inventory 2 Short Form and the University of California, Los Angeles Loneliness Scale 20 items, which are measures of social isolation and loneliness, respectively. Aim 2 was evaluated through the following metrics: participant adherence, the types of games played, friendship building and playtime, and program satisfaction and enjoyment. RESULTS: In total, 12 people enrolled (mean age 16.6, SD 1.8 years; male: n=9 and female: n=3), and 8 people completed the program. Mean attendance for the 8 participants was 77% (49 sessions of 64 total possible sessions; mean 6, SD 2 sessions). A trend was observed for improved Children's Depression Inventory 2 Short Form scores (mean preintervention score 7.25, SD 4.2; mean postintervention score 5.38, SD 4.1; P=.06; effect size=0.45, 95% CI -0.15 to 3.9), but this was not statistically significant; no difference was observed for University of California, Los Angeles Loneliness Scale 20 items scores. Most participants (7/8, 88%) stated that they became friends with a peer in class; 50% (4/8) reported that they played with other people. Participants reported high levels of enjoyment and satisfaction with how the program was implemented. Qualitative analysis resulted in 4 qualitative themes that explained behavioral mechanisms that determined engagement in the program. CONCLUSIONS: The study findings demonstrated that a brief VR group program could be valuable for potentially improving mental health among adolescents with physical disabilities. Participants built friendships with peers and other players on the web, using low-cost consumer equipment that provided easy access and strong scale-up potential. Study findings identified factors that can be addressed to enhance the program within a larger clinical trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT05259462; https://clinicaltrials.gov/study/NCT05259462. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/42651.

Increasing Physical Activity in Persons With Spinal Cord Injury With an eHealth-Based Adaptive Exercise Intervention: Protocol for a Sequential Multiple Assignment Randomized Trial.

BACKGROUND: Participating in an adequate amount of physical activity to acquire health benefits is challenging for people with spinal cord injury (SCI) due to personal and logistic barriers. Barriers in the built and social environments may include lack of transportation, lack of accessible facilities or programs, and lack of training among fitness personnel. Low self-efficacy, lack of self-regulation skills, and improper outcome expectations are examples of personal barriers. Current approaches to investigating physical activity programs in people with SCI have been limited to traditional "one-size-fits-all" design, which has yielded low adherence rates, high dropout rates, and participants not maintaining physical activity levels at follow-up. OBJECTIVE: The primary aim of this study is to test the feasibility of a tele-exercise program that applies an adaptive intervention design for 30 adults with SCI, targeting increases in adherence to the exercise program and physical activity participation. METHODS: The Sequential Multiple Assignment Randomized Trial for Home-based Exercise and Lifestyle Tele-Health (SMART-HEALTH) is a 12-week, home-based, movement-to-music (M2M) program. The goal of a SMART-designed study is to develop an adaptive intervention that modifies support provisions based on response levels. In SMART-HEALTH, 2 groups of participants will undergo 3-week and 6-week asynchronous M2M interventions in the first phase. Participants who did not achieve the desired adherence rate (≥95% of video watch minutes) will be rerandomized into M2M Live (switch) or individualized behavioral coaching (augmented with the asynchronous M2M program). The study will primarily assess rates of recruitment or enrollment, adherence and retention, timing to identify nonresponders, and scientific outcomes (eg, physical activity and exercise self-efficacy). The study will qualitatively evaluate the acceptability of the study using semistructured interviews among participants who complete the 12-week intervention. RESULTS: Recruitment procedures started in June 2022. All data are expected to be collected by September 2023. Full trial results are expected to be published by March 2024. Secondary analyses of data will be subsequently published. Results will include exercise adherence rates; changes in self-reported physical activity levels and blood pressure; and changes in secondary conditions including pain, sleep, and fatigue. Thematic analysis of semistructured interviews will include results on participant enjoyment and acceptability of SMART-HEALTH and inform modifications for future delivery of the program. CONCLUSIONS: This study will strengthen our understanding of the potential benefits of the tele-exercise intervention for people with SCI and build upon adaptive intervention design and its delivery strategies that aim to increase adoption and sustainable exercise behavior. This pilot trial will inform future SMART-designed studies and provide new and innovative strategies for investigating intervention effects on physical activity behavior in the SCI population. TRIAL REGISTRATION: ClinicalTrials.gov NCT04726891; https://classic.clinicaltrials.gov/ct2/show/NCT04726891. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47665.

U.S. Physical Activity Para Report Card for Children and Adolescents With Disabilities.

The U.S. Report Card on Physical Activity for Children and Youth has tracked 10 physical activity (PA) indicators common to the Active Healthy Kids Global Matrix since 2014. This article expands on the U.S. report cards by presenting PA indicator assessments among children and adolescents with disabilities. Grades for indicators were assigned based on a search of peer-reviewed articles presenting nationally representative data. The Global Matrix 3.0 benchmarks and grading framework guided the process. Grades for overall PA, sedentary behaviors, organized sports, and school were F, D+, D+, and D, respectively. Insufficient evidence existed to assign grades to the remaining six indicators. There is a need in the United States for targeted PA promotion strategies that are specific to children and adolescents with disabilities. Without a commitment to this effort across sectors and settings, the low grades identified in this para report card are expected to remain.

Telehealth Movement-to-Music to Increase Physical Activity Participation Among Adolescents With Cerebral Palsy: Pilot Randomized Controlled Trial.

BACKGROUND: Adolescents with cerebral palsy (CP) who have mobility limitations have almost no access to inexpensive and enjoyable home-based programs that can be disseminated on a large scale to help them independently manage their health through participation in leisure-time physical activity (LTPA). OBJECTIVE: The primary aim of this study was to determine the preliminary efficacy of the early adoption phase of an adult Movement-to-Music (M2M) program with behavioral telecoaching for increasing LTPA and activity participation compared with a waitlist control group in adolescents with CP. The secondary aim was to explore the effects of the program on perceived levels of pain and fatigue. The tertiary aim was to qualitatively evaluate the factors that influenced adherence and develop a theory that would inform the development of a more targeted M2M telehealth program for this group. METHODS: This randomized controlled trial piloted a 4-week M2M program with weekly behavioral telecoaching among 58 adolescents with CP who walked or used wheelchairs. The participants were randomized into one of 2 groups: M2M or control, which maintained their daily activities. M2M included videos that participants were asked to complete 3 times each week at home (asynchronous training). Adherence to video minutes was objectively measured using cloud-based analytics. Changes in activity and LTPA participation were measured before and after the intervention using the Children's Assessment of Participation and Enjoyment total domain scores and active physical recreation domain scores, respectively. Perceived pain and fatigue were measured using the National Institutes of Health Neuro-QoL short forms. The changes in scores were compared between the groups using analysis of covariance. A grounded theory approach was used to analyze one-on-one interviews, coaching notes, and feedback surveys. RESULTS: A total of 58 people were enrolled, of which 49 (84%) completed the primary outcome follow-up assessment. The mean adherence to the prescribed exercise video minutes across all 4 weeks was 68%, starting from 90% in week 1 and gradually declining to 43% in week 4. Mean adherence to coaching calls was 91%. Analysis of covariance revealed a statistically significant difference between the pre- to postchange scores for Children's Assessment of Participation and Enjoyment Active Physical Recreation-Intensity domain scores in favor of the intervention group (F1,47=8.76; P=.005; effect size=0.17, also known as volume of LTPA). The qualitative findings highlighted 5 critical factors that influenced participants' adherence to the program: caregiver support, video elements, suitable exercises, music, and behavioral coaching. CONCLUSIONS: This project determined that adolescents with CP responded well to an M2M telehealth program that could enhance their LTPA levels. This paper describes a theory in which adherence to a telehealth LTPA program can be optimized through functional and age-specific modifications for adolescents with CP. TRIAL REGISTRATION: ClinicalTrials.gov NCT04264390; https://clinicaltrials.gov/ct2/show/NCT04264390.

Group Telegaming Through Immersive Virtual Reality to Improve Mental Health Among Adolescents With Physical Disabilities: Pre- and Posttrial Protocol.

BACKGROUND: Adolescents with physical disabilities have higher rates of mental health conditions and issues than adolescents without disabilities, and this disparity was exacerbated by the onset of the COVID-19 pandemic. They also have limited access to on-site programs and nearby peers. OBJECTIVE: This pilot aims to investigate the potential effects of a low-dose multiplayer virtual reality telegaming program on depression, socialization, and loneliness among a cohort of children with physical disabilities. A secondary aim is to describe feasibility metrics, namely, recruitment and adherence rates and perceived program enjoyment and satisfaction. The tertiary aim is to describe behavioral mechanisms that affect participant adherence and social participation in the classes. METHODS: This study is a single-group pre- and posttest-designed trial. A single cohort of 12 children with physical disabilities will pilot a 1-month program that includes 2 supervised 1-hour sessions per week of group-based exergaming. Participants will complete questionnaires before and after the program. The primary aim measures will include the Children's Depression Inventory 2 Short Form, a measure of feelings of depression, and the UCLA Loneliness Scale, a measure of both loneliness and social isolation. Secondary aim measures will include three posttest Likert scale questionnaires: perceived program enjoyment, program satisfaction, and satisfaction with multiplayer experiences. At postintervention or dropout, participants will undergo semistructured interviews to identify behavioral mechanisms that underlie participation. Data will be reported descriptively and be supported by t tests as appropriate. RESULTS: Recruitment procedures started in July 2022. All data are expected to be collected by January 2023. Full trial results are expected to be published by March 2023. Secondary analyses of data will be subsequently published. CONCLUSIONS: This trial tests a peer-to-peer virtual reality telegaming program that includes a completely remote enrollment, assessment, and intervention protocol. This program is accessible and short in duration and frequency, allowing it to be integrated into other interventions. Knowledge obtained from this study will inform the development of a larger trial for improving the mental health and well-being of adolescents with physical disabilities. TRIAL REGISTRATION: ClinicalTrials.gov NCT05259462; https://clinicaltrials.gov/ct2/show/NCT05259462. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/42651.

Qualitative Evaluation of a Comprehensive Online Wellness Program (MENTOR) Among People With Spinal Cord Injury.

People with spinal cord injury (SCI) experience a plethora of health conditions that hinder their health and wellness. This qualitative retrospective evaluation describes the perceptions of 14 peoples with SCI, several months after they completed an eight-week telewellness community program (MENTOR-Mindfulness, Exercise and Nutrition To Optimize Resilience). The program offered daily online classes that covered three core wellness domains (mindfulness, exercise, nutrition) and one health coaching session to introduce participants to eight other wellness domains (sleep, self-care, core values, arts & leisure, outdoor time in nature; spiritual practice, relationships, contribution to others). Qualitative analysis resulted in 4 themes related to program benefits, likes, and improvement recommendations. First, participants valued the program for the social support provided by a sense of community and relationship building with peers. Second, self-regulation was facilitated by the comprehensiveness of the program components, easy online access, and shared lifestyle goals for self-improvement among peers. Third, participants reported improved psychological wellbeing and adopted healthy behaviors that were maintained long after the program. Last, future programs should include flexible class times, post-program support, specific exercise adaptations for people with limited arm function, and supplementary in-person meetings. These preliminary findings demonstrate that MENTOR may benefit the wellbeing of people with SCI and warrant further study.

How do people with physical/mobility disabilities benefit from a telehealth exercise program? A qualitative analysis.

People with neurological and physical disabilities (PWD) experience a myriad of secondary and chronic health conditions, thus, reducing their participation and quality of life. A telehealth exercise program could provide a convenient opportunity for improving health in this population. To describe participants' perceived benefits of a telehealth physical activity program among PWD, we conducted semi-structured interviews with 30 study participants after completing the 24-week program SUPER-HEALTH (Scale-Up Project Evaluating Responsiveness to Home Exercise and Lifestyle TeleHealth). Interview data were recorded, transcribed verbatim, and analyzed using inductive thematic analysis. The mean age of the sample was 51 ± 13 years, the primary disability was Multiple Sclerosis, and there were nine men (30%) and 21 (70%) women. Inductive thematic analysis resulted in four themes that include the following: (1) improved health and function, (2) increased activity participation, (3) improved psychosocial health, and (4) optimized performance and benefits. These preliminary findings provided support for the use of a home exercise program and recommendations to improve it to enhance benefits among PWD.

The Effects of Virtual Reality Tele-exergaming on Cardiometabolic Indicators of Health Among Youth With Cerebral Palsy: Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: Youth with cerebral palsy do not have enjoyable, accessible, and scalable exercise options that can empower them to independently maintain their cardiometabolic health. OBJECTIVE: The primary aim is to examine the preliminary efficacy of a 12-week home-based virtual reality tele-exergaming intervention on several indicators of cardiometabolic health in youth with cerebral palsy compared to the wait list control. A secondary aim is to describe feasibility metrics, namely, recruitment, retention, and adherence rates; perceived enjoyment; intervention safety; and management issues. The tertiary aim is to generate a theory that reveals critical behavioral mechanisms of adherence to tele-exergaming. METHODS: In this parallel group design randomized controlled trial, 34 inactive youths with cerebral palsy are randomly allocated to one of two groups: a group that immediately receives 12 weeks of virtual reality exergaming with tele-physical education or a wait list control group that undergoes their habitual activity for 12 weeks. Participants are recruited from a Children's Hospital and community network. At baseline (week 0), week 6, and week 12, high sensitivity C-reactive protein and blood insulin, hemoglobin A1c, triglycerides, cholesterol, and pressure are measured by the youth and a caregiver at home using a blood spot test kit and blood pressure cuff. They will also self-measure their lung function and body weight using a peak flow meter and bathroom scale, respectively. Collections are supervised by research staff via videoconference. Changes in outcomes are compared between and within groups using exploratory statistical analyses and descriptive statistics. At postintervention or dropout, participants will undergo semistructured interviews to identify behavioral mechanisms that underly participation. RESULTS: Recruitment procedures started in June 2022. All data are expected to be collected by October 2023. Full trial results are expected to be published by February 2024. Secondary analyses of data will be subsequently published. CONCLUSIONS: This trial tests an innovative serious exergaming virtual reality program that includes a completely remote enrollment, assessment, and intervention tele-protocol. The knowledge obtained will inform the development of a larger effectiveness trial for improving the health and well-being of youth with cerebral palsy. TRIAL REGISTRATION: ClinicalTrials.gov NCT05336227; https://clinicaltrials.gov/ct2/show/NCT05336227. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/40708.

Telehealth high-intensity interval exercise and cardiometabolic health in spinal cord injury.

BACKGROUND: The number of exercise trials examining cardiometabolic outcomes in spinal cord injury (SCI) is low, and prescribed exercise is often inconvenient for individuals with SCI to perform within their community. Individuals with SCI experience a myriad of barriers to exercise participation, which can include a lack of time, accessible or usable equipment and facilities, and transportation. Thus, it is imperative to identify effective modes of exercise that provide the greatest overall health benefits but do not require a significant time commitment. Low-volume high intensity interval training (HIIT) has demonstrated the same improvements in cardiometabolic health as moderate intensity exercise training (MIT), despite only requiring 20% of the total time commitment in adults without disabilities and more recently in individuals with SCI. OBJECTIVES: The primary purpose of this study is to integrate a 16 week home-based telehealth HIIT arm crank exercise training program in individuals with SCI and assess changes in cardiometabolic health. METHODS: Men and women between the ages of 19 and 60 with a confirmed diagnosis of SCI between C7 and T12 will be recruited for this study. Participants will be randomized to 16 weeks of telehealth HIIT exercise two days per week or a no-exercise control group. Aerobic capacity, muscular strength, blood lipids, glucose tolerance, resting energy expenditure, blood pressure, and body composition will be assessed at baseline and 16 weeks post-training. DISCUSSION: Inactivity associated with SCI leads to chronic cardiometabolic health conditions. The majority of exercise interventions to date show that exercise is capable of increasing physical function, aerobic capacity, and muscle mass, and strength. Additionally, we have recently shown the ability of HIIT to improve blood lipid and glucose concentrations. Advances in telehealth exercise approaches have improved the capability to prescribe home-based exercise programs. Therefore, we hypothesize that the utilization of a home-based telehealth HIIT program will improve cardiometabolic health markers, yield high adherence (> 75%), and will be more enjoyable in individuals with SCI. TRIAL REGISTRATION: Telehealth High-Intensity Interval Exercise and Cardiometabolic Health in Spinal Cord Injury NCT04940598.

Supporting successful recruitment in a randomized control trial comparing clinic and home-based exercise among adults with multiple sclerosis.

BACKGROUND: The Tele- Exercise and Multiple Sclerosis (TEAMS) study, funded by the Patient Centered Outcome Research Institute (PCORI), is a pragmatic, cluster randomized controlled trial aimed at comparing the effectiveness of a 12-week complementary and alternative medicine (CAM) program for people with multiple sclerosis (MS) delivered by a therapist at a clinic and the same program initiated by the participant at home using a tablet and pre-recorded videos. The 20-session CAM program consists of yoga, Pilates and dual tasking exercises. The study aimed to enroll 820 participants with MS living in Alabama, Mississippi and Tennessee. MAIN BODY: The information provided in this paper describes the strategies that led to the largest randomized controlled exercise trial ever conducted for people with multiple sclerosis. Specifically, the paper presents the result of incorporating stakeholder engagement, a novel participant recruitment method, to produce a successful recruitment outcome for a comparative effectiveness randomized controlled trial. This study used three tiers of engagement: panel members (9 members), clinical partners (88 occupational and physical therapists), and community organizations (6 non-profits). CONCLUSION: Engagement of the stakeholder panel, clinical partners and community organizations led to interest of over 1700 people with MS across three states in the Deep South (final enrollment was n = 837). The diversity of our stakeholder groups and their extensive reach into various communities were a critical aspect for achieving our target sample size. The recruitment numbers reflect the importance of involving multiple stakeholder groups at project inception, developing relationships over time, utilizing member strengths, and monitoring their engagement on a regular basis to ensure a meaningful experience for all involved. TRIAL REGISTRATION: NCT03117881. Registered 18 April 2017, https://clinicaltrials.gov/ct2/show/NCT03117881?term=tele+rehabilitation&cond=Multiple+Sclerosis&cntry=US&state=US%3AAL&draw=2&rank=1 .

The Tele Exercise and Multiple Sclerosis (TEAMS) study has been able to successfully screen over 1700 people with multiple sclerosis (MS) across three southern states (Alabama, Mississippi, Tenessee) largely due to the advice and input that the research team received from a stakeholder panel, clinic partners and community organizations. These groups met before the study was submitted for funding to the Patient-Centered Outcome Research Institute (PCORI), and was awarded in 2017. These engagement stages and framework established early in the study process were instrumental in generating strong enthusiasm for the study among various MS constituency groups. The feedback from our stakeholders, clinic partners, and community organizations led to the creation of a variety of recruitment methods (print material, email, social media, attendance at events, and health fairs) to connect with potential participants in a setting convenient within each location. In approximately 26 months, the study enrolled 837 participants with MS and baseline tested 759 individuals who participated in a rehabilitative exercise program at either a clinic site or in their home using a tablet that they were given (and kept) which included a set of preloaded videos. All milestones established by PCORI and research staff were met, leading to the largest exercise trail ever conducted with people with MS.

Retrospective evaluation of a pilot eHealth/mHealth telewellness program for people with disabilities: Mindfulness, Exercise, and Nutrition To Optimize Resilience (MENTOR).

Background: People with disabilities have few options to participate in wellness programs that are tailored to their health, functional level, specific interests/needs, and available in the comfort of their home. To address this need, we evaluated a mobile health wellness program for people with physical disabilities. Methods: Retrospective pilot evaluation of MENTOR (Mindfulness, Exercise, and Nutrition To Optimize Resilience), an 8-week, 40-hour online telewellness program adapted from the peer reviewed literature on wellness. The three core wellness domains-mindfulness, exercise, and nutrition-were delivered via Zoom to groups of participants with a disability. Each group met weekly with an assigned health coach who responded to Q&A about the program and presented new material on several additional wellness domains that could impact their health (e.g., relationships, contribution to society/community, spending outdoor time in nature). Pre/post measures included the Godin Leisure-Time Exercise Questionnaire (GLTEQ) and the UAB/Lakeshore Wellness Assessment (LWA). Participants were also interviewed and provided feedback after the program, which was thematically analyzed. Results: A total of 154 people from 15 states enrolled in the MENTOR program and 135 completed it (87.7% completers). Data were analyzed from a subset of participants (n=53) who were asked to complete a pre/post assessment and had complete data. Participants who were physically inactive at baseline improved their GLTEQ total activity (P=0.002; effect size =0.56) and moderate-to-vigorous activity scores (P=0.005; effect size =0.53). LWA results demonstrated that participants increased their exercise behavior (P=0.006; effect sizes =0.39) and contribution to society/community (P=0.013; effect size =0.37). Participants with low overall wellness (mental, physical & emotional health) at baseline had statistically significant improvements in exercise, nutrition, sleep, core values, self-care, hobbies, contribution to society/community, relationships, and overall wellness (all P<0.05 with effect sizes ranging from 0.43 to 1.07). Resultant qualitative themes were: (I) lifestyle transformation occurred through new positive experiences, physical and mental health benefits, and adoption of healthy behaviors; and (II) engagement through accessible online bonding through enjoyable and professional experiences. Conclusions: A pilot telewellness program for people with disabilities is feasible and potentially effective in improving several domains of wellness. There is a need for precision-based mobile health (mHealth) programs that are tailored for people with disabilities and that can be accessed from various portable devices including their phone and/or tablet.

The impact of COVID-19 on the lifestyles of adolescents with cerebral palsy in the Southeast United States.

BACKGROUND: The impact of COVID-19 on adolescents with cerebral palsy (CP) and their families is underinvestigated, particularly in the Southeastern United States. OBJECTIVE/HYPOTHESIS: The objective of this study was to examine the impact of COVID-19 on lifestyle activities, general and mental health, and basic needs among a cohort of adolescents with CP in the Southeast U.S. The second purpose was to identify key factors that impacted their lifestyles. METHODS: This was a cross-sectional survey of adolescents with CP (aged 10-19 years) who completed a child-modified version of the Coronavirus Disability Survey. Health and behavior items were associated with the perceived lifestyle impact of COVID-19. RESULTS: A total of 101 respondents completed the survey (mean age: 14 ± 2 years). Respondents reported minimal to no change in general health since the COVID-19 outbreak. Basic needs were met for most families. Nearly all participants (94.1%) reported a mental health concern that resulted from COVID-19: 32.7% felt down or depressed; 47.5% felt little pleasure in doing things; and 64.4% felt isolated. Moreover, 74.3% reported decreased socialization, 51.5% reported reduced exercise participation, and 43.6% reported difficulties in obtaining medical care. Most participants (90.1%) were negatively affected by COVID-19, and key associated factors were reduced interactions with friends and family (p = 0.001), exercise participation (p = 0.016), interest in doing things (p = 0.005), worsened depression (p = 0.015), increased isolation from others (p = 0.02) and at home (p = 0.006), technological communication (p = 0.00), and virus exposure (p = 0.008). CONCLUSIONS: Study findings highlight problem areas that warrant urgent intervention among adolescents with CP located within the Southeast U.S.

Wrist-based accelerometer cut-points for quantifying moderate-to-vigorous intensity physical activity in Parkinson's disease.

BACKGROUND: Persons with Parkinson's disease (PD) participate in low levels of physical activity. This has prompted interest in developing interventions targeting physical activity behavior in PD. However, the current cut-points to quantify moderate-to-vigorous physical activity (MVPA) developed for PD have been derived from a single, vertical axis using hip-worn accelerometers, and this cut-point may not be applicable for wrist-worn devices. Wrist-worn devices might improve accessibility and compliance with physical activity monitoring in PD. RESEARCH QUESTION: What is the relationship between wrist-based activity counts and energy expenditure during treadmill walking in persons with PD? Do cut-points for quantifying time spent in MVPA differ between persons with PD and controls matched by age and sex? METHODS: The sample included 26 persons with mild-to-moderate PD (Hoehn and Yahr stages 2-3) and 27 age- and sex-matched controls. Participants completed three, 6-minute bouts of walking on a treadmill at three increasing speeds. Vector magnitude was measured using ActiGraph GT3X+ accelerometer worn on the more affected side for persons with PD and the non-dominant side for controls. The rate of oxygen consumption, or energy expenditure, was measured using a portable, open-circuit spirometry system. RESULTS: Our results indicated a strong association between activity counts and energy expenditure for persons with PD and controls with R2 values of 0.94(0.07) and 0.95(0.06), respectively. Persons with PD had a cut-point of 2883(871) counts·min-1; this was significantly lower than the cut-point of 4389(1844) counts·min-1 for controls. CONCLUSION: We generated a PD-specific cut-point for wrist-worn ActiGraph accelerometers among persons with PD, and this was lower than controls. This disease-specific cut-point may provide more accurate measurements of time spent in MVPA in PD.

The movement-to-music (M2M) study: study protocol for a randomized controlled efficacy trial examining a rhythmic teleexercise intervention for people with physical disabilities.

BACKGROUND: People with physical disabilities need exercise routines that are enjoyable, readily available in the home, adapted to their functional level, and eliminate common barriers to exercise participation related to transportation and time commitment. The purpose of the movement-to-music (M2M) study is to address these issues by establishing a remotely delivered, rhythmic exercise program for people with physical disabilities. METHODS: The study is a two-arm randomized controlled efficacy trial examining a 12-week remotely delivered M2M intervention (eM2M) in 108 people with physical disabilities. The primary outcomes are changes in cardiorespiratory fitness and muscle strength at post 12-week intervention. DISCUSSION: The eM2M study will enhance our understanding of an alternative intervention design and delivery mode that removes common barriers to exercise participation experienced by people with physical disabilities. The eM2M intervention may be an alternative option for people with physical disabilities to obtain regular exercise, especially during a pandemic when exercising in indoor facilities may be problematic. TRIAL REGISTRATION: ClinicalTrials.gov NCT03797378. Registered on January 9, 2019, with the trial name "Movement-to-Music: Lakeshore Examination of Activity, Disability, and Exercise Response Study (M2M LEADERS)".

Teleassessments for Enrollment of Adults With Physical or Mobility Disability in a Home-Based Exercise Trial in Response to COVID-19: Usability Study.

BACKGROUND: The Scale-Up Project Evaluating Responsiveness to Home Exercise And Lifestyle Tele-Health (SUPER-HEALTH) initiative is a large randomized controlled study that aims to overcome logistical barriers to exercise via telehealth for people with physical disabilities. However, at the start of the COVID-19 pandemic, enrollment was halted due to limited operations at the testing site, which included no onsite visits that involved participant data collection. In response to the limited operations, a modified data collection protocol was developed for virtual enrollment of study participants. OBJECTIVE: This paper presents feasibility data on using teleassessments to enroll people with mobility impairment into a home-based exercise trial. METHODS: The modified protocol replaced onsite enrollment and data collection visits with teleassessments using a computer tablet and testing equipment that was shipped to the participants' home address prior to the synchronous teleassessments conducted by an exercise physiologist through Zoom. The participants were mailed a teleassessment toolkit that included a digital blood pressure cuff, spirometer, hand dynamometer, mini disc cone, and measuring tape (to complete standardized testing). The teleassessment measures included resting blood pressure and heart rate, forced vital capacity, grip strength, Five Times Sit to Stand, and Timed Up and Go. Feasibility metrics included technological effectiveness, efficiency, and safety. The technological effectiveness of the telehealth assessment was determined by the percentage of sessions completed without technical issues with ≥90% criteria set a priori. Efficiency was measured by a session duration of ≤2 hours. Safety was measured by the number of adverse events related to the teleassessments reported. RESULTS: Data from 36 participants were included in this feasibility study, and 34 (94%) participants completed all teleassessments without technical issues. For efficiency, the teleassessment sessions were completed in a mean time of 65 minutes and a maximum session length of 110 minutes. There were no adverse events reported to indicate concerns with the safety of teleassessments. CONCLUSIONS: The modified teleassessment protocol, in response to COVID-19 restrictions, may be a feasible process for enrolling adults with mobility impairment into a home exercise trial who otherwise would have not been able to participate. TRIAL REGISTRATION: ClinicalTrials.gov NCT03024320; https://clinicaltrials.gov/ct2/show/NCT03024320.

Participation of people living with disabilities in physical activity: a global perspective.

Approximately 1·5 billion people worldwide live with a physical, mental, sensory, or intellectual disability, about 80% of which are in low-income and middle-income countries. This Series paper provides a global overview of the prevalence, benefits, and promotion policies for physical activity for people living with disabilities (PLWD). PLWD are 16-62% less likely to meet physical activity guidelines and are at higher risk of serious health problems related to inactivity than people without disabilities. Meta-analyses have shown that physical activity has beneficial effects on cardiovascular fitness (average standardised mean difference [SMD] 0·69 [95% CI 0·31-1·01]), musculoskeletal fitness (0·59 [0·31-0·87]), cardiometabolic risk factors (0·39 [0·04-0·75]), and brain and mental health outcomes (0·47 [0·21-0·73]). These meta-analyses also show that health benefits can be achieved even with less than 150 min of physical activity per week, and suggest that some physical activity is better than none. Meta-analyses of interventions to increase physical activity for PLWD have reported effect sizes ranging from SMD 0·29 (95% CI 0·17-0·41, k=10) to 1·00 (0·46-1·53, k=10). There is increasing awareness among policy makers of the needs of PLWD for full participation in physical activity. Physical activity action plans worldwide must be adequately resourced, monitored, and enforced to truly advance the fundamental rights of PLWD to fully participate in physical activity.

Accuracy and precision of wrist-worn actigraphy for measuring steps taken during over-ground and treadmill walking in adults with Parkinson's disease.

INTRODUCTION: Step counts represent a straight-forward method of measuring physical activity in adults with Parkinson's disease (PD). The present study examined the absolute and relative accuracy and precision of a wrist-worn research-grade accelerometer (i.e., ActiGraph GT3X+) for measuring step counts during over-ground and treadmill walking in adults with PD and controls without PD. METHODS: Participants (PD: n = 29; controls: n = 31) wore two ActiGraph GT3X + accelerometers, one on each wrist, and completed an over-ground walking bout followed by a treadmill walking bout at the same speed. Step counts were measured manually using a hand-held tally counter. Accuracy and precision were based on absolute and relative metrics. RESULTS: The ActiGraph GT3X + underestimated step counts in both participants with PD (4.7-11% error) and controls without PD (8.8-17% error), with a greater discrepancy in controls. The ActiGraph GT3X + provided more accurate and precise estimates of step counts when placed on the more affected wrist and non-dominant wrist for participants with PD and controls, respectively, and was more accurate and precise during over-ground walking compared with treadmill walking for both groups. CONCLUSIONS: Our results suggest that placement of the device (i.e., dominant vs. non-dominant), type of activity (i.e., over-ground vs. treadmill walking), and presence of clinical conditions may impact the accuracy and precision of data when using the research-grade ActiGraph GT3X + accelerometer for measuring step counts.