A prospective non-randomized feasibility study of an online membership-based fitness program for promoting physical activity in people with mobility impairments.

BACKGROUND: People with mobility limitations have a disproportionately higher rate of acquiring secondary conditions such as obesity, cardiovascular comorbidity, pain, fatigue, depression, deconditioning, and type 2 diabetes. These conditions often result from poor access to home and community-based health promotion/wellness programs. The aim of this project was to determine the feasibility of delivering an online community membership-based fitness program for individuals with mobility impairments. METHODS: For this prospective single-arm study, participants were recruited from members of a community fitness facility that serves people with physical disabilities and chronic health conditions. While all members had access to the online platform, individuals had to opt-in to participate in the research component. Activity options included 16 pre-recorded videos and 9 live exercise classes. During the 8-week program, participants had an opportunity to earn three exercise incentives for reaching certain activity milestones. Enrollment percentage, attendance, and attrition were tracked to assess program feasibility and acceptability. Changes in participant-reported outcomes including self-reported physical activity, psychosocial outcomes, and health-related quality of life (HRQOL) were examined using non-parametric analyses. RESULTS: A total of 146 eligible individuals were screened of which 33 enrolled (22.6%). Two participants withdrew from the study, so a total of 31 were used for analyses. Participants included 29 women and 12 Black people with an average age of 60 (± 15.9) years. Health conditions included stroke, post-polio, arthritis, neuropathy, cerebral palsy, and obesity. Ten participants used an assistive device to get around inside the home. Twenty-six participants (78.8%) completed the online program, and 5 participants earned all 3 participation incentives. The mean number of live Zoom exercise classes attended by the participants was 12.8 (range = 0-43) over 8 weeks; 3 of 31 participants did not attend any classes. On average, participants watched 128 min (range = 0-704 min) of pre-recorded videos; 6 of 31 participants did not view any pre-recorded videos. Self-reported physical activity showed the largest improvement (11.15 units; 95% CI, 3.08, 19.56) with an effect size of 0.51 (Cohen's d). CONCLUSIONS: This pilot study of an online membership-based fitness program for people with mobility impairments demonstrated preliminary effectiveness in increasing physical activity and was found to be feasible and acceptable. Feasibility endpoints do indicate potential to improve retention. These results suggest that online delivery of exercise programs can broaden the reach of specialized community fitness programs and is a promising direction for future work and fully powered trials are warranted to assess intervention efficacy. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05138809. Registered September 2, 2021, ClinicalTrials.gov PRS: Record Summary NCT05138809.

mHealth-Based Just-in-Time Adaptive Intervention to Improve the Physical Activity Levels of Individuals With Spinal Cord Injury: Protocol for a Randomized Controlled Trial.

BACKGROUND: The lack of regular physical activity (PA) in individuals with spinal cord injury (SCI) in the United States is an ongoing health crisis. Regular PA and exercise-based interventions have been linked with improved outcomes and healthier lifestyles among those with SCI. Providing people with an accurate estimate of their everyday PA level can promote PA. Furthermore, PA tracking can be combined with mobile health technology such as smartphones and smartwatches to provide a just-in-time adaptive intervention (JITAI) for individuals with SCI as they go about everyday life. A JITAI can prompt an individual to set a PA goal or provide feedback about their PA levels. OBJECTIVE: The primary aim of this study is to investigate whether minutes of moderate-intensity PA among individuals with SCI can be increased by integrating a JITAI with a web-based PA intervention (WI) program. The WI program is a 14-week web-based PA program widely recommended for individuals with disabilities. A secondary aim is to investigate the benefit of a JITAI on proximal PA, defined as minutes of moderate-intensity PA within 120 minutes of a PA feedback prompt. METHODS: Individuals with SCI (N=196) will be randomized to a WI arm or a WI+JITAI arm. Within the WI+JITAI arm, a microrandomized trial will be used to randomize participants several times a day to different tailored feedback and PA recommendations. Participants will take part in the 24-week study from their home environment in the community. The study has three phases: (1) baseline, (2) WI program with or without JITAI, and (3) PA sustainability. Participants will provide survey-based information at the initial meeting and at the end of weeks 2, 8, 16, and 24. Participants will be asked to wear a smartwatch every day for ≥12 hours for the duration of the study. RESULTS: Recruitment and enrollment began in May 2023. Data analysis is expected to be completed within 6 months of finishing participant data collection. CONCLUSIONS: The JITAI has the potential to achieve long-term PA performance by delivering tailored, just-in-time feedback based on the person's actual PA behavior rather than a generic PA recommendation. New insights from this study may guide intervention designers to develop engaging PA interventions for individuals with disability. TRIAL REGISTRATION: ClinicalTrials.gov NCT05317832; https://clinicaltrials.gov/study/NCT05317832. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/57699.

New technology to address affected vs nonaffected arm contributions to ergometer performance in people poststroke.

BACKGROUND: When pedaling a coupled-crank arm ergometer, individuals with hemiplegia may experience nonparetic arm overcompensation, and paretic arm resistance, due to neuromechanical deficits. Technologies that foster independent limb contributions may increase the effectiveness of exercise for people poststroke. OBJECTIVE: Examine the speed during uncoupled pedaling with the Advanced Virtual Exercise Environment Device among individuals poststroke and non-impaired comparisons. METHODS: We recruited 2 groups:Poststroke and Comparison. Participants attended one lab session and performed peak speed tests and a graded exercise repeated for bilateral pedaling, unilateral (left, right). RESULTS: Thirty-one participants completed the protocol (16 women, 15 men). Poststroke participants pedaled slower during the bilateral speed test (64 ± 39 RPM, p < .001), and graded exercise, (54 ± 28 RPM, p < .001) versus comparisons (141 ± 19, 104 ± 12 RPM). Poststroke individuals had lower peak RPM during the unilateral speed test with their paretic arm (70 ± 46 RPM, p < .001) and graded exercise (58 ± 33 RPM, p < .001) compared to their unilateral speed test (130 ± 37 RPM) and graded exercise (108 ± 25 RPM) with their nonparetic arm. Comparisons did not differ between arms during speed tests and graded exercise. Poststroke participants demonstrated lower peak speed with their affected arm during the bilateral speed test (52 ± 42 RPM, p < .001) and graded exercise (49 ± 28 RPM, p = .008) compared to the same arm during unilateral speed (70 ± 46 RPM) and graded exercise (58 ± 33 RPM). CONCLUSIONS: Poststroke participants pedaled faster with their affected arm unilaterally versus bilateral pedaling, suggesting interhemispheric interference that reduces the ability to recruit the paretic arm during bilateral exercise.

Telehealth Behavioral Intervention for Chronic Disease Self-Management in Adults With Physical Disabilities (My Health, My Life, My Way): Protocol for Intervention Fidelity and Dashboard Design for a Randomized Controlled Trial.

BACKGROUND: Individuals with physical disabilities experience higher rates of chronic health conditions than individuals without physical disabilities. Self-management programs that use health coaching are effective at eliciting health behavior change in health outcomes such as goal setting, adherence, and health care use. Additionally, web-based resources such as telehealth-based technologies, including SMSS text messaging, web-based applications, and educational multimedia content, can complement health coaching to improve health-related behaviors and the use of health services. The complexity of studies using these resources requires a fidelity protocol to ensure that health behavior studies are administered properly. OBJECTIVE: The My Health, My Life, My Way fidelity protocol provides methods, strategies, and procedures of a multifaceted telehealth program for individuals with permanent physical disabilities and chronic health conditions. This health behavior study is a randomized controlled trial with four study arms: (1) scheduled coaching calls with gamified rewards, (2) no scheduled coaching calls with gamified rewards, (3) scheduled coaching calls with fixed rewards, and (4) no scheduled coaching calls with fixed rewards. To guide the fidelity protocol developed, we used the National Institutes of Health Behavior Change Consortium framework (NIH BCC). METHODS: The fidelity intervention protocol was developed by using the 5 primary domains provided by the NIH BCC: study design, provider training, treatment delivery, treatment receipt, and enactment of treatment skills. Following the NIH BCC guidelines and implementing social cognitive theory, this study is designed to ensure that all study arms receive equal treatment across conditions and groups. Health coaches and providers will be trained to deliver consistent health coaching, and thus participants will receive appropriate attention. Educational content will be developed to account for health literacy and comprehension of the material. Multiple fidelity intervention steps such as coaching call logs, regular content review, and participant progress monitoring will translate to participants using the skills learned in their daily lives. Different monitoring steps will be implemented to minimize differences among the 4 treatment groups. RESULTS: My Health, My Life, My Way has been approved by the institutional review board and will begin enrollment in January 2024 and end in December 2024, with results reported in early 2025. CONCLUSIONS: Intervention fidelity protocols are necessary to ensure that health behavior change studies can be implemented in larger real-world settings. The My Health, My Life, My Way fidelity protocol has used the guidelines by the NIH BCC to administer a telehealth intervention combined with health coaching for individuals with physical disabilities and chronic health conditions. This fidelity protocol can be used as a complementary resource for other researchers who conduct similar research using telehealth technologies and health coaching in real-world settings. TRIAL REGISTRATION: ClinicalTrials NCT05481593; https://clinicaltrials.gov/study/NCT05481593. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/53410.

Impact of the COVID-19 Pandemic on Physical Activity among Mostly Older, Overweight Black Women Living in the Rural Alabama Black Belt.

Despite well-documented global declines in physical activity (PA) during the COVID-19 pandemic, little is known regarding the specific impact among underserved, rural Alabama counties. This is concerning as this region was already disproportionately burdened by inactivity and related chronic diseases and was among the hardest hit by COVID-19. Thus, the current study examined the effect of COVID-19 on PA in four rural Alabama counties. An ancillary survey was administered between March 2020 and August 2021 to the first cohort (N = 171) of participants enrolled in a larger PA trial. Main outcomes of this survey included the perceived impact of COVID-19 on PA, leisure-time PA, and social cognitive theory (SCT) constructs at 3 months. Almost half of the participants reported being less active during the pandemic (49.7%) and endorsed that COVID-19 made PA more difficult (47.4%), citing concerns such as getting sick from exercising outside of the home (70.4%) and discomfort wearing a face mask while exercising (58%). Perceived COVID-19 impact on PA was significantly associated with education, household dependents, and gender (p's < 0.05). More women, parents, and college graduates reported that the COVID-19 pandemic made PA more difficult. Overall, there were no significant associations between PA, SCT constructs, or perceived COVID-19 impact on PA scores at 3 months. While the pandemic made PA difficult for many participants, these barriers were not associated with leisure-time PA levels or related theoretical mechanisms of action, which bodes well for the success of our ongoing intervention efforts and the resiliency of these communities.

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.

Development and Formative Evaluation of a Virtual Exercise Platform for a Community Fitness Center Serving Individuals With Physical Disabilities: Mixed Methods Study.

BACKGROUND: People with disabilities experience numerous barriers to being physically active, such as transportation issues, a lack of trained exercise professionals who understand disabilities, and facility access. The use of a virtual exercise platform (VEP) may provide an alternative and limit certain barriers. OBJECTIVE: The aim of this mixed method study was to evaluate user interaction (effectiveness, efficiency, and satisfaction), the strengths and weaknesses of the user interface, and the user experience with a VEP. METHODS: Participants were recruited from a community fitness facility that offers programs for people with disabilities. Inclusion criteria were being older than 18 years, fluent in English, and availability of internet access. Features of the VEP included articles, prerecorded videos, live Zoom classes, web-based class registration, weekly progress tracking, incentives, and surveys. A one-on-one Zoom session was scheduled with each participant, during which they completed certain tasks: (1) create an account or login, (2) register for class, (3) join class, (4) add to calendar, and (5) complete surveys. As participants completed tasks, quantitative observations (time on task, task success, rate of task completion, and number of errors by users, which determined task difficulty), qualitative observations were made and interviews were conducted at the end of the session. The "concurrent think-aloud" method was encouraged by the moderator to gauge participants' thoughts as they worked through testing. Participants also completed the System Usability Scale (SUS) and Questionnaire for User Interface Satisfaction (QUIS). RESULTS: A total of 5 people with disabilities (3 male, 2 female), aged 36-78 (mean 54) years, with education levels from high school to PhD, were recruited. Devices used for testing included a laptop (n=3), a Chromebook (n=1), and a desktop (n=1). All participants completed tasks #1 and #2 without errors but could not complete task #4. One participant completed task #5 with difficulty and another completed task #3 with difficulty. The average time to complete each task was: (1) 82 seconds (55-110), (2) 11 seconds (4-21), (3) 9 seconds (5-27), and (4) 921.5 seconds (840-958). The mean SUS score was 86.5/100, and the mean user QUIS score was 8.08 out of 10. Qualitative observations indicated that the system was simple, user-friendly, and accessible. CONCLUSIONS: People with disabilities reported high usability and user satisfaction with the web-based exercise platform, and the system appears to be an efficient and effective physical activity option.

The Usability of a Touchpad Active Video Game Controller for Individuals With Impaired Mobility: Observational Study.

BACKGROUND: Video games are a popular sedentary activity among people with impaired mobility; however, active video game hardware typically lacks accessibility and customization options for individuals with mobility impairments. A touchpad video game system can elicit moderate physical activity in healthy adults; however, it is unclear if this system is usable by adults with impaired mobility. OBJECTIVE: The purpose of this study was to assess the usability of a touchpad video game controller system adapted for adults with impaired mobility. Additional outcomes explored were enjoyment, perceived exertion, self-efficacy, participant feedback, and researcher observations of gameplay. METHODS: Participants played several video game titles for 20 minutes with a touchpad video game controller as they stood or sat in a chair or their wheelchair. Usability was assessed with the System Usability Scale (SUS) and the Health Information Technology Usability Evaluation Scale (Health-ITUES) surveys after gameplay. After each video game, participants reported enjoyment using a visual analog scale (0 to 100 mm) and a rating of perceived exertion using the OMNI 0 to 10 scale. Self-efficacy was measured before and after gameplay. Participants provided feedback at the end of their session. RESULTS: In total, 21 adults (6 females and 15 males) with a mean age of 48.8 (SD 13.8) years with various mobility impairments participated in this study. The touchpads received mean usability scores on the SUS 80.1 (SD 18.5) and Health-ITUES 4.23 (SD 0.67). CONCLUSIONS: The SUS scores reported suggest the touchpad system is "usable"; however, the Health-ITUES scores were slightly below a suggested benchmark. Participants reported moderate to high enjoyment but perceived the exertion as "somewhat easy." Self-efficacy was moderate to high and did not differ pre- to postgame play. The participants regarded the touchpads as novel, fun, and entertaining. The generalizability of our results is limited due to the heterogenous sample; however, our participants identified several areas of improvement for future iteration.

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.

My Health, My Life, My Way-An Inclusive Web-Based Self-management Program for People With Disabilities Living With Chronic Conditions: Protocol for a Multiphase Optimization Strategy Study.

BACKGROUND: Individuals with disabilities living with chronic health conditions require self-management programs that are accessible, sustainable, inclusive, and adaptable. Health coaching is an effective approach to promoting behavior change in self-management. Health coaching combined with telehealth technology has the potential to improve the overall quality of, and access to, health services. OBJECTIVE: This protocol outlines the study design for implementing the My Health, My Life, My Way intervention. The study will assess the feasibility, acceptability, and preliminary efficacy of the intervention for people with disabilities and optimize it. METHODS: The My Health, My Life, My Way study is a 4-arm randomized controlled trial evaluating the delivery of a 6-month intervention involving telecoaching, inclusive educational content, and technology access for 200 individuals with chronic conditions and physical disabilities. This study uses the engineering-inspired multiphase optimization strategy (MOST) framework to evaluate intervention components and assess whether a combination or lack of individual elements influences behavior. Participants will be randomized to 1 of 4 study arms: scheduled coaching calls and gamified rewards, no scheduled coaching calls and gamified rewards, scheduled coaching calls and flat rewards, and no scheduled coaching calls and flat rewards. RESULTS: The My Health, My Life, My Way study was approved by the institutional review board of the University of Alabama at Birmingham, and recruitment and enrollment will begin in May 2023. Data analysis is expected to be completed within 6 months of ending data collection. This clinical trial protocol was developed based on the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 statement. CONCLUSIONS: The My Health, My Life, My Way study will help to optimize and improve our understanding of the feasibility and efficacy of a web-based self-management program for people with physical disabilities and chronic conditions. More specifically, My Health, My Life, My Way will determine which combination of interventions (coaching calls and gamification) will result in increased participation in self-management programming. The My Health, My Life, My Way intervention has the potential to become a scalable and novel method to successfully manage chronic conditions in people with disabilities. TRIAL REGISTRATION: ClinicalTrials.gov NCT05481593; https://clinicaltrials.gov/ct2/show/NCT05481593. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/31694.

Usability of the GAIMplank Video Game Controller for People With Mobility Impairments: Observational Study.

BACKGROUND: Replacing sedentary behaviors during leisure time with active video gaming has been shown to be an enjoyable option for increasing physical activity. However, most off-the-shelf active video gaming controllers are not accessible or usable for individuals with mobility impairments. To address this requirement, a universal video game controller (called the GAIMplank) was designed and developed. OBJECTIVE: This study aimed to assess the usability of the GAIMplank video game controller for playing PC video games among individuals with mobility impairments. Measures of enjoyment, perceived exertion, and qualitative data on the user experience were also examined. METHODS: Adults (aged 18-75 years) with a mobility impairment were recruited to participate in a single testing session in the laboratory. Before testing began, basic demographic information, along with minutes of weekday and weekend physical activity, minutes of weekday and weekend video game play, and video game play experience were collected. The GAIMplank was mapped to operate as a typical joystick controller. Depending on their comfort and functional ability, participants chose to play seated in a chair, standing, or in their own manual wheelchair. Leaning movements of the trunk created corresponding action in the game (ie, lean right to move right). The participants played a total of 5 preselected video games for approximately 5 minutes each. Data were collected to assess the usability of the GAIMplank, along with self-efficacy regarding execution of game play actions, rating of perceived exertion and enjoyment for each game, and overall qualitative feedback. RESULTS: A total of 21 adults (n=15, 71% men; n=6, 29% women) completed the usability testing, with a mean age of 48.8 (SD 13.8; range 21-73) years. Overall, 38% (8/21) of adults played while standing, 33% (7/21) of adults played while seated in a chair, and 29% (6/21) played in their own manual wheelchair. Scores from the System Usability Scale indicated above average (74.8, SD 14.5) usability, with scores best for those who played seated in a chair, followed by those standing, and then individuals who played seated in their own wheelchairs. Inconsistencies in the responsiveness of the controller and general feedback for minor improvements were documented. Rating of perceived exertion scores ranged from light to moderate intensity, with the highest scores for those who played seated in a chair. Participants rated their experience with playing each game from above average to very enjoyable. CONCLUSIONS: The GAIMplank video game controller was found to be usable and accessible, providing an enjoyable option for light-to-moderate intensity exercise among adults with mobility impairments. Minor issues with inconsistencies in controller responsiveness were also recorded. Following further development and refinement, the next phase will include a pilot exercise intervention using the GAIMplank system.

An Interactive Voice Response System to Increase Physical Activity and Prevent Cancer in the Rural Alabama Black Belt: Design and Usability Study.

BACKGROUND: Increased physical activity (PA) levels are associated with reduced risk and improved survival for several cancers; however, most Americans engage in less than the recommended levels of PA. Using interactive voice response (IVR) systems to provide personalized health education and counseling may represent a high-reach, low-cost strategy for addressing physical inactivity and cancer disparities in disproportionately burdened rural regions. However, there has been a paucity of research conducted in this area to date. OBJECTIVE: The aim of this study is to design, develop, and test the usability of an IVR system aimed at increasing PA levels in the rural Alabama Black Belt. METHODS: A pilot version of the IVR system was used to assess initial feasibility and acceptability. Detailed exit interviews were conducted to elicit participant feedback, which helped inform the development of a substantially upgraded in-house IVR system. This refined IVR system was then subjected to a sequential explanatory mixed methods evaluation. Participating rural county coordinators and research staff (N=10) tested the usability of the IVR system features for 2 weeks and then completed the System Usability Scale and qualitative semistructured interviews. RESULTS: The study sample comprised mostly African American people, women, rural county coordinators, and research staff (N=10). Participants rated the IVR system with a mean score of 81 (SD 5) on the System Usability Scale, implying excellent usability. In total, 5 overarching themes emerged from the qualitative interviews: likes or dislikes of the intervention, barriers to or facilitators of PA, technical difficulties, quality of calls, and suggestions for intervention improvement. Message framing on step feedback, call completion incentives, and incremental goal-setting challenges were areas identified for improvement. The positive areas highlighted in the interviews included the personalized call schedules, flexibility to call in or receive a call, ability to make up for missed calls, narration, and PA tips. CONCLUSIONS: The usability testing and feedback received from the rural county coordinators and research staff helped inform a final round of refinement to the IVR system before use in a large randomized controlled trial. This study stresses the importance of usability testing of all digital health interventions and the benefits it can offer to the intervention.

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)".

Disability-Inclusive Diabetes Self-management Telehealth Program: Protocol for a Pilot and Feasibility Study.

BACKGROUND: Individuals with disabilities and type 2 diabetes require self-management programs that are accessible, sustainable, inclusive, and adaptable. Health coaching has been shown to be an effective approach for improving behavioral changes in self-management. Health coaching combined with telehealth technology has the potential to improve the overall quality of and access to health services. OBJECTIVE: This protocol outlines the study design for implementing the Artificial Intelligence for Diabetes Management (AI4DM) intervention. The protocol will assess the feasibility, acceptability, and preliminary efficacy of the AI4DM telehealth platform for people with disabilities. METHODS: The AI4DM study is a 2-arm randomized controlled trial for evaluating the delivery of a 12-month intervention, which will involve telecoaching, diabetes educational content, and technology access, to 90 individuals with diabetes and physical disabilities. The hypothesis is that this pilot project is feasible and acceptable for adults with permanently impaired mobility and type 2 diabetes. We also hypothesize that adults in the AI4DM intervention groups will have significantly better glycemic control (glycated hemoglobin) and psychosocial and psychological measures than the attention control group at the 3-, 6-, and 12-month follow-ups. RESULTS: The AI4DM study was approved by the university's institutional review board, and recruitment and enrollment will begin in October 2021. CONCLUSIONS: The AI4DM study will improve our understanding of the feasibility and efficacy of a web-based diabetes self-management program for people with disabilities. The AI4DM intervention has the potential to become a scalable and novel method for successfully managing type 2 diabetes in people with disabilities. TRIAL REGISTRATION: ClinicalTrials.gov NCT04927377; https://clinicaltrials.gov/ct2/show/NCT04927377. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/31689.

Telehealth Behavioral Intervention for Diabetes Management in Adults With Physical Disabilities: Intervention Fidelity Protocol for a Randomized Controlled Trial.

BACKGROUND: Diabetes mellitus is a major health problem among people with physical disabilities. Health coaching has been proven to be an effective approach in terms of behavioral changes, patient self-efficacy, adherence to treatment, health service use, and health outcomes. Telehealth systems combined with health coaching have the potential to improve the quality of health care by increasing access to services. Treatment fidelity is particularly important for behavior change studies; however, fidelity protocols are inadequately administered and reported in the literature. OBJECTIVE: The aim of this study is to outline all the intervention fidelity strategies and procedures of a telecoaching intervention-artificial intelligence for diabetes management (AI4DM)-which is a randomized controlled trial to evaluate the feasibility, acceptability, and preliminary efficacy of a telehealth platform in adults with type 2 diabetes and permanent impaired mobility. AI4DM aims to create a web-based disability-inclusive diabetes self-management program. We selected the National Institutes of Health Behavior Change Consortium (NIH BCC) fidelity framework to describe strategies to ensure intervention fidelity in our research. METHODS: We have developed fidelity strategies based on the five fidelity domains outlined by the NIH BCC-focusing on study design, provider training, treatment delivery, treatment receipt, and enactment of treatment skills. The design of the study is grounded in the social cognitive theory and is intended to ensure that both arms would receive the same amount of attention from the intervention. All providers will receive standardized training to deliver consistent health coaching to the participants. The intervention will be delivered through various controlling and monitoring strategies to reduce differences within and between treatment groups. The content and structure of the study are delivered to ensure comprehension and participation among individuals with low health literacy. By constantly reviewing and monitoring participant progress and protocol adherence, we intend to ensure that participants use cognitive and behavioral skills in real-world settings to engage in health behavior. RESULTS: Enrollment for AI4DM will begin in October 2021 and end in October 2022. The results of this study will be reported in late 2022. CONCLUSIONS: Developing and using fidelity protocols in behavior change studies is essential to ensure the internal and external validity of interventions. This study incorporates NIH BCC recommendations into an artificial intelligence embedded telecoaching platform for diabetes management designed for people with physical disabilities. The developed fidelity protocol can provide guidance for other researchers conducting telehealth interventions within behavioral health settings to present more consistent and reproducible research. TRIAL REGISTRATION: ClinicalTrials.gov NCT04927377; http://clinicaltrials.gov/ct2/show/NCT04927377. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/31695.

Challenges and Lessons Learned From a Telehealth Community Paramedicine Program for the Prevention of Hypoglycemia: Pre-Post Pilot Feasibility Study.

BACKGROUND: Prevention through Intervention is a community paramedicine program developed by Birmingham Fire and Rescue Services in Alabama. This program aims to reduce dependency on emergency medical services (EMS) for nonemergency-related events through education and to lower the frequency of emergency calls in underserved populations. A telehealth intervention with an emphasis on hypoglycemia was implemented to (1) tailor the intervention to meet the educational needs of participants and (2) facilitate follow-ups. A pre-post pilot feasibility evaluation of the telehealth intervention was conducted. OBJECTIVE: This paper describes the results of the feasibility evaluation, implementation challenges, and the lessons learned about the deployment of a hypoglycemia prevention program in an underserved area and its evaluation. METHODS: This single-arm pretest-posttest intervention included (1) an initial in-person visit (week 1), (2) 3 weekly telecoaching calls (weeks 2-4), (3) 1 biweekly call (week 6), and (4) a final in-person visit (week 8) for collecting posttest data from individuals who called EMS due to hypoglycemic events. In-person visits included educational sessions conducted by EMS personnel. Participants' education included tailored content related to hypoglycemia. Weekly telecoaching calls focused on hypoglycemia symptom monitoring and education reinforcement via a telehealth dashboard. The primary measures focused on feasibility measures, and exploratory measures focused on the fear of hypoglycemia, self-efficacy, and a knowledge of diabetes. RESULTS: A total of 40 participants participated in the intervention. However, the study was marred with high attrition. The various factors behind the low retention rate were discussed. There was a decreasing trend in all three subdomains of the fear of hypoglycemia from pretest to posttest. There was also a significant increase in participants' self-efficacy in hypoglycemia self-management (P=.03). CONCLUSIONS: This study shows preliminary and promising results for a community-based intervention specifically for hypoglycemia. However, the socioeconomic setting in which the intervention was delivered may have resulted in high dropout rates and low attendance during the intervention, which are considerations for future telehealth studies. TRIAL REGISTRATION: ClinicalTrials.gov NCT03665870; https://clinicaltrials.gov/ct2/show/NCT03665870.

Active Video Gaming Using an Adapted Gaming Mat in Youth and Adults With Physical Disabilities: Observational Study.

BACKGROUND: A common leisure-time activity amongst youth and adults in the United States is video gameplay. Playing video games is typically a sedentary endeavor; however, to encourage an increased level of physical activity in an engaging and enjoyable way, active video gaming has become popular. Unfortunately, the accessibility of gaming controllers is often an issue for persons with disabilities. A commercial off-the-shelf (OTS) gaming mat was adapted to facilitate use by individuals with mobility impairments to address this issue. OBJECTIVE: Our study aimed to examine energy expenditure, enjoyment, and gameplay experience in youth and adults with mobility impairment during active video gaming using an OTS and adapted versions of a gaming mat. METHODS: The study used an observational design. During visit 1, physical function was assessed, and participants were given a familiarization period with the gaming system. For visit 2, based on observation during the physical function tests and discussion with the participant, it was decided whether the participant would play in a standing or seated position. For standing gameplay, the mat was placed on the floor, and for seated play, the mat was placed on a height-adjustable and tilt-adjustable tabletop. Metabolic data were collected during a 20-minute baseline and four 10-minute bouts of Wii Fit Plus gameplay, with 2 bouts on each of the mats (adapted and OTS). During gameplay, the research staff observed and rated participants' ability to use the game controller (mat) and the quality of gameplay. At the end of each game set, participants reported their rating of perceived exertion on a scale from 0 to 10. During rest, participants completed the physical activity enjoyment scale. Participants also answered additional questions regarding the system's usability with each controller (adapted mat and OTS mat). Statistical analyses were computed using Stata 16 (version 16.1; StataCorp). Linear mixed-effects maximum likelihood regression was performed separately for individuals who could play standing and for those who played seated. RESULTS: A convenience sample of 78 individuals with mobility impairments between the ages of 12 and 60 years (mean 39.6, SD 15.8) participated in the study. Of the sample, 48 participants played the video games in a seated position, while 30 played the games standing. Energy expenditure and heart rate tended to be higher in the OTS mat condition for seated players, while values were similar for both conditions among standing players. However, seated participants reported greater gameplay experience, and both groups exhibited a higher quality of gameplay during the adapted mat condition. CONCLUSIONS: Active video gaming using an adapted gaming mat provided an enjoyable exercise activity for individuals with mobility impairments. The use of the adapted controller provides a means by which this population can engage in light to moderate intensity active video gaming, thereby reducing sedentary leisure time. TRIAL REGISTRATION: ClinicalTrials.gov NCT02994199; https://clinicaltrials.gov/ct2/show/NCT02994199.

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.