Enhancements to a Telewellness Program for People With Physical Disabilities: Mindfulness, Exercise, and Nutrition To Optimize Resilience (MENTOR 2.0).

Introduction: This study evaluated the National Center on Health, Physical Activity and Disability (NCHPAD) Mindfulness, Exercise, and Nutrition To Optimize Resilience (MENTOR) program for people with physical disabilities. Methods: This retrospective evaluation of MENTOR 2.0, an 8-week online group health promotion program, was based on improvements from its first implementation (MENTOR 1.0). Baseline and postassessments included the Godin Leisure-Time Exercise Questionnaire (GLTEQ), NCHPAD Wellness Assessment (NWA), Connor-Davidson Resilience Scale, and Mindfulness Attention Awareness Scale. Estimates and corresponding 95% CIs from linear mixed models were provided to compare baseline and postassessment scores and effect sizes using Cohen d. Results: Among 116 participants (mean age, 53 y; 63% female), postassessment scores increased significantly in the overall NWA and in all 15 NWA domains (effect size, 0.30-0.69). The overall NWA score was 7.59 (95% CI, 5.63-9.56) units higher at postassessment compared with baseline. Scores for GLTEQ health contribution increased significantly among participants with low baseline scores (31.37 [95% CI, 12.97-49.77]) (effect size, 0.50). Mindfulness and resilience scores both showed improvement (0.16 [95% CI, 0.01-0.31]; effect size, 0.15) and (0.72 [95% CI, -0.25 to 1.68]; effect size 0.09), respectively, but only the change in mindfulness was significant. Conclusion: MENTOR 2.0 advanced the evaluation of this online telewellness program for people with physical disabilities by demonstrating consistent results with MENTOR 1.0. We reported improvements in GLTEQ, especially among those with lower baseline scores; in multiple areas of wellness, including physical, mental, and emotional/spiritual health; and in mindfulness and resilience, although the improvements in these 2 constructs were small.

Stakeholders' Perspectives, Needs, and Barriers to Self-Management for People With Physical Disabilities Experiencing Chronic Conditions: Focus Group Study.

BACKGROUND: While self-management programs have had significant improvements for individuals with chronic conditions, less is known about the impact of self-management programs for individuals with physical disabilities who experience chronic conditions, as no holistic self-management programs exist for this population. Similarly, there is limited knowledge of how other stakeholders, such as caregivers, health experts, and researchers, view self-management programs in the context of disability, chronic health conditions, and assistive technologies. OBJECTIVE: This study aimed to obtain insight into how stakeholders perceive self-management relating to physical disability, chronic conditions, and assistive technologies. METHODS: Nine focus groups were conducted by 2 trained facilitators using semistructured interview guides. Each guide contained questions relating to stakeholders' experiences, challenges with self-management programs, and perceptions of assistive technologies. Focus groups were audio recorded and transcribed. Thematic analysis was conducted on the focus group data. RESULTS: A total of 47 individuals participated in the focus groups. By using a constructivist grounded approach and inductive data collection, three main themes emerged from the focus groups: (1) perspectives, (2) needs, and (3) barriers of stakeholders. Stakeholders emphasized the importance of physical activity, mental health, symptom management, medication management, participant centeredness, and chronic disease and disability education. Participants viewed technology as a beneficial aide to their daily self-management and expressed their desire to have peer-to-peer support in web-based self-management programs. Additional views of technology included the ability to access individualized, educational content and connect with other individuals who experience similar health conditions or struggle with caregiving duties. CONCLUSIONS: The findings suggest that the development of any web-based self-management program should include mental health education and resources in addition to physical activity content and symptom management and be cost-effective. Beyond the inclusion of educational resources, stakeholders desired customization or patient centeredness in the program to meet the overall needs of individuals with physical disabilities and caregivers. The development of web-based self-management programs should be holistic in meeting the needs of all stakeholders. TRIAL REGISTRATION: ClinicalTrials.gov NCT05481593; https://clinicaltrials.gov/study/NCT05481593.

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.

COVID-19 Modifications for Remote Teleassessment and Teletraining of a Complementary Alternative Medicine Intervention for People With Multiple Sclerosis: Protocol for a Randomized Controlled Trial.

BACKGROUND: Access to comprehensive exercise and rehabilitation services for people with multiple sclerosis (MS) remains a major challenge, especially in rural, low-income areas. Hence, the Tele-Exercise and Multiple Sclerosis (TEAMS) study aims to provide patient-centered, coordinated care by implementing a 12-week complementary and alternative medicine (CAM) intervention for adults with MS. However, due to the societal impact of coronavirus disease (COVID-19) in mid-March 2020, the University of Alabama at Birmingham announced a limited business model halting all nonessential research requiring on-site visits, which includes the TEAMS study. OBJECTIVE: In compliance with the shelter-in-place policy and quarantine guidance, a modified testing and training protocol was developed to allow participants to continue the study. METHODS: The modified protocol, which replaces on-site data collection and training procedures, includes a teleassessment package (computer tablet, blood pressure cuff, hand dynamometer, mini disc cone, measuring tape, an 8" step, and a large-print 8" × 11" paper with ruler metrics and wall-safe tape) and a virtual meeting platform for synchronous interactive training between the therapist and the participant. The teleassessment measures include resting blood pressure and heart rate, grip strength, Five Times Sit to Stand, Timed Up & Go, and the Berg Balance Scale. The teletraining component includes 20 sessions of synchronous training sessions of dual tasking, yoga, and Pilates exercises designed and customized for a range of functional levels. Teletraining lasts 12 weeks and participants are instructed to continue exercising for a posttraining period of 9 months. RESULTS: The protocol modifications were supported with supplemental funding (from the Patient-Centered Outcomes Research Institute) and approved by the University Institutional Review Board for Human Use. At the time nonessential research visits were halted by the university, there were 759 people enrolled and baseline tested, accounting for 92.5% of our baseline testing completion target (N=820). Specifically, 325 participants completed the 12-week intervention and follow-up testing visits, and 289 participants needed to complete either the intervention or follow-up assessments. A modified analysis plan will include sensitivity analyses to ensure the robustness of the study results in the presence of uncertainty and protocol deviations. Study results are projected to be published in 2021. CONCLUSIONS: This modified remote teleassessment/teletraining protocol will impact a large number of participants with MS who would otherwise have been discontinued from the study. TRIAL REGISTRATION: ClinicalTrials.gov NCT03117881; https://clinicaltrials.gov/ct2/show/NCT03117881. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/18415.

A Mobile App to Promote Adapted Exercise and Social Networking for People With Physical Disabilities: Usability Study.

BACKGROUND: People with physical disabilities (PWD) experience several unique challenges that prevent them from participating in onsite exercise programs. Although mobile apps can provide a ubiquitous channel for delivering convenient exercise services within the community, no exercise apps have been designed for people with disabilities who experience certain functional limitations. OBJECTIVE: The aim of this study was to examine the usability of a mobile exercise app in PWD. METHODS: A sequential explanatory mixed-method design was used to holistically test usability in 4 core areas: effectiveness (ie, ease of use), efficiency (ie, operation speed), perceived satisfaction, and usefulness. Participants completed 7 face-to-face usability tasks and 1 structured interview. Equipment included a computer tablet that came preinstalled with the exercise app. The app included exercise videos that focused on several components of fitness: aerobic capacity, muscular strength, functional strength or balance, and range of motion. The app contained 3 different versions of the exercise program: (1) a program for people with the ability to use the upper and lower limbs, (2) a seated program for people with the ability to use only upper limbs, and (3) a program designed for people with hemiparesis. The app also included educational resources in the form of infographics aimed at addressing key social cognitive theory constructs included social support, outcome expectancies, self-efficacy, and barriers or facilitators to exercising. Participant characteristics and quantitative usability data were descriptively reported. Qualitative data were analyzed using thematic analysis. RESULTS: A total of 12 PWD tested the usability of the exercise app and completed 96% (69/72) of the usability tasks on the first attempt. Operation speed varied among users, which prompted the development team to make minor revisions to the app. Qualitative results demonstrated 3 overarching themes: facilitates exercise adoption, positive experiences of videos, and easy to learn. Participants noted that the app circumvented several barriers to exercise associated with leaving the home (eg, inclement weather conditions, exacerbations of health conditions or disability symptoms, difficulties with transportation, and social support). CONCLUSIONS: The mobile exercise app provided a simple platform that was effective, useful, and appreciated by PWD. Participants also perceived the app as easy to use and felt it was a valuable tool for assisting PWD to obtain regular exercise. Study findings also offered insight into the participants' preferences for mobile exercise apps that can aid future research and development projects. Future exercise trials are needed to determine the true impact of mobile app technology on lifestyle physical activity in people with disabilities. TRIAL REGISTRATION: Clinicaltrials.gov NCT03024320; https://clinicaltrials.gov/ct2/show/NCT03024320 (Archived by WebCite at http://www.webcitation.org/75hNLgRFH).

The Effects of M2M and Adapted Yoga on Physical and Psychosocial Outcomes in People With Multiple Sclerosis.

OBJECTIVE: To investigate the effects of two 12-week exercise training interventions, movement-to-music (M2M) and adapted yoga (AY), on physical and psychosocial outcomes in people with multiple sclerosis (MS). DESIGN: Three-arm randomized controlled proof-of-concept trial. SETTING: A community-based fitness facility. PARTICIPANTS: Participants (N=81) with MS (Patient Determined Disease Steps [PDDS] self-reported disease status scores: 0-6) between ages of 18 and 65 years were randomized to M2M (n=27), AY (n=26), or waitlist control (n=28). INTERVENTIONS: Both M2M and AY completed three 60-minute exercise sessions per week for 12 weeks. Waitlist controls received biweekly newsletters via mail that contained educational information on living with MS. MAIN OUTCOME MEASURES: Primary measures were timed Up and Go (TUG, s) test, 6-minute walk test (6MWT, m), and 5 times sit-to-stand test (FTSST, s). Secondary measures were self-reported outcomes assessed using Patient-Reported Outcomes Measurement Information System Fatigue and Pain Interference Short Form 8a. Participants were evaluated at baseline and postintervention. Primary analyses were performed using an intent-to-treat mixed model analysis of covariance. RESULTS: Comparisons across all 3 groups revealed significant group differences in TUG and 6MWT. Post hoc analyses indicated significant improvements in TUG (least square mean difference [95% confidence interval] = -1.9s [-3.3 to -0.5], P=.01, d=0.7) and 6MWT (41.0m [2.2-80.0], P=.04, d=0.6; controlled for PDDS) in M2M compared to controls, while no significant differences were observed when compared AY to controls. No significant group differences were found in FTSST, fatigue, and pain interference. CONCLUSIONS: M2M may be a useful and enjoyable exercise form for people with MS in improving mobility and walking endurance and merits long-term study in larger study populations.

Rationale and design of the tele-exercise and multiple sclerosis (TEAMS) study: A comparative effectiveness trial between a clinic- and home-based telerehabilitation intervention for adults with multiple sclerosis (MS) living in the deep south.

Long-term exercise/rehabilitation is an integral component of the continual care for people with multiple sclerosis (MS). However, access to this care, which includes comprehensive exercise/rehabilitation services to people with MS, remains a significant challenge, especially in rural, low-income areas. Telerehabilitation, or what we refer to as teleexercise, can help fill service gaps for underserved MS populations in this region. This pragmatic, cluster randomized controlled effectiveness trial will compare a 12-week, 20 session complementary and alternative medicine (CAM) intervention composed of neurorehabilitative (functional) exercise, yoga and Pilates delivered at home, using pre-loaded tablets and Interactive Voice Response (IVR) system technology (TeleCAM), to the same intervention delivered in clinic by a therapist (DirectCAM). Eight hundred and twenty people with MS are being recruited across Alabama, Mississippi and Tennessee. Primary self-reported patient-centered health outcomes are: pain, fatigue, quality of life and physical activity. Secondary outcomes include four physical functioning measures: balance, endurance, gait, and strength. Each of these outcomes will be examined by age, race, sex, severity of MS and other demographics to determine if outcomes are beneficial across all groups (i.e., heterogeneity of treatment effect). The project is important to people with MS and/or caregivers because it aims to reduce their barriers to receiving exercise treatment and increases the convenience and appeal of such programs through technology. Clinical Trials.gov Identifier: NCT03117881.