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.

Critical factors influencing the decision to enroll in a physical activity intervention among a predominant group of adults with spinal cord injury: a grounded theory study.

STUDY DESIGN: Grounded theory qualitative approach. OBJECTIVES: To examine critical factors associated with interest in enrolling in a physical activity (PA) research intervention among a predominant group of adults with spinal cord injury (SCI) and develop a theory that can enhance future recruitment success. SETTING: Participants were recruited through the network of a community exercise facility for people with physical disabilities. METHODS: Interviews were conducted with 22 wheelchair users (mean age 46 ± 13 years; SCI [n = 19], cerebral palsy [n = 1]; multiple sclerosis [n = 1]; and bilateral limb loss [n = 1]) in either a one-on-one format or focus group. Interview data were coded, and these codes were organized into conceptual categories using a constructivist grounded theory framework. RESULTS: Adults with SCI conceive three core concerns with enrolling into a PA trial: (1) capability to participate in the program due to scheduling, transportation, and secondary health conditions; (2) mental balancing of anticipated benefits versus the difficulty of starting the program; and (3) desirability of the program characteristics based on their preferences and needs. Concerns were organized into a theory that may enhance future recruitment success. CONCLUSIONS: Recruitment is often overlooked in PA research for people with SCI despite it being a primary rate-limiting factor that severely limits the external validity of published studies. Study findings identified core recruitment concerns that are likely similar with general barriers to PA participation. This paper proposed a 3-step decision-making process that can serve as a starting point for overcoming recruitment issues in PA research with people with SCI.

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.

Comparisons of ultrasound-estimated intramuscular fat with fitness and health indicators.

INTRODUCTION: We examined ultrasound-estimated intramuscular fat of 4 muscles: rectus femoris (RF), biceps femoris (BF), tibialis anterior (TA), and medial gastrocnemius (MG), and compared the results with other health measures. METHODS: Forty-two participants were tested. Muscle echo intensity was quantified into percent intramuscular fat using previously published equations. RESULTS: Strong correlations were found in percent intramuscular fat in the 4 muscles (r ≥ 0.8). Weak to moderate correlations were found between intramuscular fat and body mass index (r ≥ 0.2), waist/hip ratio (r ≥ 0.2), muscle thickness (r = -0.5 in RF, r = -0.4 in TA, r = -0.7 in MG), and muscle strength (leg extension: r = 0.4; leg flexion: r = -0.5). A relationship between intramuscular fat in RF and MG and physical activity was also observed (P < 0.05). CONCLUSION: Ultrasound-estimated intramuscular fat was associated with other health measures and may provide physiological insight into the health consequences of obesity. Muscle Nerve 54: 743-749, 2016.

Bending the Arc of Exercise and Recreation Technology Toward People With Disabilities.

Most of the published research on exercise and disability has focused on short-term efficacy studies targeting specific disability groups. These studies often use grant-related or other financial resources to temporarily remove the many barriers that people with physical/mobility disability experience when attempting to become physically active. In this commentary, we explore how technology can be used to promote more sustainable physical activity outcomes in the home and community using a set of 4 overlapping domains: Access, Usability, Adherence, and Health and Function. In addition, we describe how the order in which these domains should be addressed will vary depending on the needs of the target group and the context of their environment. Finally, we provide examples of various types of technologies (eg, hardware and software) that can support the "afterlife" of successful short-term exercise and rehabilitation trials in people with physical/mobility disability who desire to self-manage their own health and maintain a regular and sustainable pattern of physical activity across their life span.

Measurement of intramuscular fat by muscle echo intensity.

INTRODUCTION: The aim of this study was to compare ultrasound echo intensity (EI) with high-resolution T1 -weighted MRI and to establish calibration equations to estimate percent intramuscular fat from EI. METHODS: Thirty-one participants underwent both ultrasound and MRI testing of 4 muscles: rectus femoris (RF); biceps femoris (BF); tibialis anterior (TA); and medial gastrocnemius (MG). RESULTS: Strong correlations were found between MRI percent fat and muscle EI after correcting for subcutaneous fat thickness (r = 0.91 in RF, r = 0.80 in BF, r = 0.80 in TA, r = 0.76 in MG). Three types of calibration equations were established. CONCLUSIONS: Muscle ultrasound is a practical and reproducible method that can be used as an imaging technique for examination of percent intramuscular fat. Future ultrasound studies are needed to establish equations for other muscle groups to enhance its use in both research and clinical settings.

Pilot evaluation of a behavioral weight loss program for adults with physical disabilities: State of Slim Everybody usability and feasibility.

Background: People with physical disabilities (PWD) have a higher prevalence of obesity than populations without disability, but most evidence-based weight loss programs have not included this population. The State of Slim (SOS) program is an evidence-based weight loss program that has demonstrated success in producing weight loss in populations without disability, but it has not been adapted for or evaluated in PWD. Methods: The SOS program was systematically adapted using the evidence-informed Guidelines, Recommendations, and Adaptations Including Disability (GRAIDs) framework. A total of 35 participants enrolled in the State of Slim Everybody program. The program was offered entirely online. Body weight, attendance, and food log completion were also tracked weekly. The program length was 16.5 h and included weekly group instruction, with optional one-on-one sessions provided upon request. Following completion, participants completed post-evaluation surveys on overall satisfaction with the program. The primary outcomes were program effectiveness (i.e., body weight), usability, and feasibility. Results: Thirty-two out of 35 participants completed the program, representing a retention rate of 91.4%. Average weight loss was 10.9% (9.9 ± 0.7 kg (t (31) = -13.3, p =< 0.0001)). On a 1 (dissatisfied/completely useless) to 5 (very satisfied/completely helpful) Likert scale, the average score for overall program satisfaction was 4.8 ± 0.1 and program helpfulness 4.6 ± 0.1. Conclusion: The State of Slim Everybody program demonstrated significant weight loss and good usability and feasibility in PWD. Existing adaptation frameworks can be used to create inclusive health promotion programs for adults with physical disabilities.

Improvements in nutrition knowledge among adults with physical disabilities: A program evaluation of the mindfulness, exercise, and nutrition to optimize resilience (MENTOR) program 2020-2021.

BACKGROUND: The Centers for Disease Control and Prevention (CDC) funds a quality improvement (QI) health promotion telewellness program for adults with physical disabilities. OBJECTIVE: The nutrition component of the parent program, Mindfulness, Exercise, and Nutrition to Optimize Resilience (MENTOR) program, from 2020 to 2021, was evaluated to assess changes in nutrition knowledge of people with physical disabilities. METHODS: This was a quasi-experimental program evaluation by pre-post survey of participating adults with physical disabilities. Participants attended weekly nutrition classes for eight weeks with optional one-on-one counseling with a Registered Dietitian. Participants completed pre-post General Nutrition Knowledge Questionnaire Revised (GNKQ-R) that were analyzed using paired t-tests. Participants were grouped into quartiles by pre-program GNKQ-R scores for additional comparisons. Program attendance and post-program feedback were also evaluated. RESULTS: A total of 286 participants completed the MENTOR program, and 31% (n = 89) completed pre-post questionnaires for data analysis. Mean pre-program GNKQ-R scores were 58.4 ± 15.1 and post scores were 64.4 ± 11.3, which demonstrated a statistically significant improvement in nutrition knowledge (p < .001). Ancillary analysis revealed that participants with the lowest quartile of pre-program nutrition knowledge had the greatest improvements in their post-GNKQ-R scores (Mean change 16.4 ± 13.9). Questionnaire data revealed participants' subjective knowledge changes and their feedback on the nutrition component of the program. CONCLUSIONS: The eight-week MENTOR program effectively improved nutrition knowledge among people with physical disabilities. This demonstrates the impact the program can have on individual knowledge levels. Additionally, these results support the implementation of the program to the broader population of people with disabilities.

Case report: endurance electrical stimulation training improves skeletal muscle oxidative capacity in chronic spinal cord injury.

OBJECTIVE: To describe the use of a novel neuromuscular electrical stimulation (NMES) endurance exercise protocol and its effects on skeletal muscle oxidative capacity. DESIGN: Case report, pre/post intervention. SETTING: University-based trial. PARTICIPANT: A 39-year-old man who suffered a motor complete spinal cord injury (C5-6, ASIA Impairment Scale grade A). INTERVENTION: Twenty-four weeks of endurance NMES that consisted of progressive increases in the twitch frequency, duration of sessions, and sessions per week. MAIN OUTCOME MEASURE: Mitochondrial capacity was measured, in vivo, as the rate of recovery of muscle oxygen consumption using near-infrared spectroscopy. RESULTS: The rate of recovery of muscle oxygen consumption increased approximately 3-fold from 0.52 to 1.43, 1.46, and 1.40/min measured on 3 separate occasions during week 12 of training, and 1.57/min after 24 weeks of NMES endurance training. CONCLUSION: The findings of this study suggest that NMES endurance training using twitches can increase mitochondrial capacity to comparable levels measured in nonparalyzed muscles of sedentary able-bodied controls.

Near-infrared assessments of skeletal muscle oxidative capacity in persons with spinal cord injury.

After spinal cord injury (SCI) skeletal muscle decreases in size, increases in intramuscular fat, and has potential declines in mitochondrial function. Reduced mitochondrial function has been linked to the development of metabolic disease. The aim of this study was to measure mitochondrial function in persons with SCI using near-infrared spectroscopy (NIRS). Oxygen consumption of the vastus lateralis muscle was measured with NIRS during repeated short-duration arterial occlusions in nine able-bodied (AB) and nine persons with motor complete SCI. Skeletal muscle oxidative capacity (V max) was evaluated with two approaches: (1) rate constant of the recovery of oxygen consumption after exercise and (2) extrapolated maximum oxygen consumption from a progressive work test. V max as indicated by the rate constant (k) from the recovery kinetics test was lower in SCI compared with AB participants (k: SCI 0.7 ± 0.3 vs. AB 1.9 ± 0.4 min(-1); p < 0.001). Time constants were SCI 91.9 ± 37.8 vs. AB 33.6 ± 8.3 s. V max from the progressive work test approached a significant difference between groups (SCI 5.1 ± 2.9 vs. AB 9.8 ± 5.5 % Hb-Mb/s; p = 0.06). NIRS measurements of V max suggest a deficit of 50-60 % in participants with SCI compared with AB controls, consistent with previous studies using (31)P-MRS and muscle biopsies. NIRS measurements can assess mitochondrial capacity in people with SCI and potentially other injured/diseased populations.

A qualitative evaluation of a clinic versus home exercise rehabilitation program for adults with multiple sclerosis: The tele-exercise and multiple sclerosis (TEAMS) study.

BACKGROUND: Substantial evidence supports therapeutic exercise for improving health and function in people with multiple sclerosis (MS). However, few studies have considered the patients' perspective. OBJECTIVE: This study explored perspectives of adults with MS following participation in a 3-month clinic- and home-based exercise rehabilitation program. METHODS: Twenty participants with MS were interviewed using a semi-structured interview guide on the design and implementation processes of the exercise programs as well as any perceived facilitators or barriers to exercise. Data analysis was conducted using a thematic analysis approach to generate themes from the transcribed interviews. RESULTS: Key facilitators of exercise for people with MS included perceived improvements in physical health and function, activity participation, and psychosocial health. Mismatched level of exercise with their stage of post-diagnosis and/or functional ability and limited human interaction emerged as barriers to exercise. CONCLUSIONS: Participation in the exercise program was a positive experience for people with MS. Despite the provision of a high level of adaptation and tailored exercise plan and delivery, self-directed exercise continued to present challenges for people with MS. Additionally, the importance of seeking cost-effective ways to maintain motivational support was implicit in participant responses. The findings provided an improved understanding of personal experiences and exercise perspectives that can inform future intervention strategies aimed at promoting sustained exercise participation.

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.

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.

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.

The Effects of a Movement-to-Music (M2M) Intervention on Physical and Psychosocial Outcomes in People Poststroke: A Randomized Controlled Trial.

OBJECTIVE: To investigate the effects of a 12-week movement-to-music (M2M) intervention on physical and psychosocial outcomes in people poststroke. DESIGN: Two-arm randomized controlled trial. SETTING: A community-based fitness facility. PARTICIPANTS: Participants (N=47) with stroke between 18 and 65 years old were randomized to M2M (n=23) or waitlist control (n=24). INTERVENTIONS: Participants in M2M completed 3 60-minute exercise sessions per week for 12 weeks. Controls received biweekly educational newsletters via mail. MAIN OUTCOME MEASURES: Primary outcomes included Six-Minute Walk Test (6MWT, in meters), Five Times Sit-to-Stand Test (FTSST, in seconds) and Timed Up and Go (TUG, in seconds). Secondary outcomes were self-reported measures using Patient-Reported Outcomes Measurement Information System Fatigue and Pain Interference Short Form 8a. Outcomes were collected at baseline and postintervention. Analyses involved descriptive statistics and adjusted linear mixed models. RESULTS: Mixed models adjusted for the respective baseline values and demographic variables showed that M2M participants had longer 6MWT distance (least square mean difference [LSM], 14.5; 95% confidence interval [CI], -12.9 to 42.0), more FTSST time (LSM, 2.0; 95% CI, -4.5 to 8.5), and less fatigue (LSM, -3.0; 95% CI, -7.2 to 1.2) compared with controls postintervention. When controlling for baseline TUG and demographic variables, there was a larger increase in 6MWT distance (LSM, 37.9; 95% CI, -22.7 to 98.6), lower FTSST time (LSM, -6.1; 95% CI, -18.5 to 6.2), and decrease in fatigue (LSM, -6.5; 95% CI, -13.1 to 0.2) in the M2M group compared with controls. Moderate effect sizes were observed for improving 6MWT (d=0.6), FTSST (d=-0.6), and fatigue (d=-0.6). There was no group difference in change in TUG time and pain interference, with trivial effect sizes (d=-0.1). CONCLUSION: M2M may be a valuable exercise form for adults with stroke. Future studies are needed to determine optimal exercise doses for improving health and function in this population.

The Spinal Cord Injury Program in Exercise (SCIPE) study: study protocol for a randomized controlled trial evaluating teleexercise programs for people with spinal cord injury.

BACKGROUND: Many people with spinal cord injury (SCI) have limited access to tailored, readily available exercise resources. As a result, exercise remains an underutilized treatment strategy for improving health and function in people with SCI. The purpose of this study is to test the effectiveness of two remotely delivered exercise programs for people with SCI. METHODS: The Spinal Cord Injury Program in Exercise (SCIPE) study is a three-arm adaptive randomized controlled trial examining two 8-week teleexercise interventions: Movement-to-Music (M2M) and Standard Exercise Training (SET), compared to Attention Control (AC) in 327 adults with SCI. The primary outcome is change in physical activity level at post 8-week intervention. The study contains two interim analyses. The first interim analysis will assess feasibility metrics of the protocol after 36 participants complete the 8-week intervention period. The second interim analysis will examine two effectiveness comparisons: SET vs. AC and M2M vs AC, after 165 participants complete the intervention period. Early termination of the intervention arm(s) will take place when non-significant findings are found in the corresponding intervention(s). Incorporation of such interim analysis enhances trial efficiency by dropping the intervention(s) that deemed ineffective. It provides ethical benefits and allows allocation of additional resources to explore the effective intervention(s). DISCUSSION: Delivery of teleexercise programs may be an effective strategy for addressing transportation barrier to exercise resources and increasing physical activity level and quality of life in people with SCI. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03925077 . Registered trial name: Spinal Cord Injury Program in Exercise (SCIPE). Registered on April 23rd, 2019.

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.

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)".

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.