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BACKGROUND: Children with mobility disabilities, including those with cerebral palsy, have limited options and limited time to exercise to manage their cardiometabolic health and cardiorespiratory fitness. Regular cardiovascular exercise during childhood is a critical health behavior for preventing health decline in adulthood. Thus, there is an urgent need for accessible, age-appropriate, convenient exercise modalities in this group. Sprint-intensity interval training (SIT), combined with telehealth procedures, may be ideal for children with disabilities. SIT includes repetitive bouts of maximal exercise effort combined with rest periods, which can be effective in eliciting comparable results to moderate-exercise training with very short training durations. OBJECTIVE: This phase 1 pilot feasibility randomized controlled trial aims to investigate the potential effects of a 12-week SIT program on indicators of cardiorespiratory fitness and cardiometabolic health among children with cerebral palsy. An ancillary aim is to evaluate the feasibility of the program through several process feasibility metrics. METHODS: This study uses a 2-armed parallel group design. A total of 50 physically inactive children with cerebral palsy (aged 6-17 years) will be randomly allocated into 1 of 2 groups: a 12-week SIT or a waitlist control group that continues habitual activity for 12 weeks. The SIT prescription includes 3 tele-supervised sessions per week with 30 repeated sequences of 4 seconds of maximal arm exercise, with active recovery, warm-up, and cooldown periods (for an approximately 20-minute total session). SIT includes guided videos with child-themed arm routines and music. The exercise sessions will be remotely supervised through a web-based videoconference application and include safety monitoring equipment. Outcomes are measured at pre- and postintervention (weeks 0 and 13, respectively). Health outcome measures include peak oxygen consumption (VO2 peak), measured by a graded exercise test; high-sensitivity C-reactive protein and blood insulin, hemoglobin A1c, triglycerides, and cholesterol using a finger stick dried blood spot test; blood pressure, using a sphygmomanometer; and body composition (total mass, total lean mass, tissue % lean, and tissue % fat) using dual x-ray absorptiometry. Feasibility will be evaluated by the following metrics: adverse events or problems experienced throughout the intervention related to participant safety; perceived enjoyment; and recruitment, enrollment, and attrition rates. RESULTS: Recruitment procedures started in November 2023. All data are anticipated to be collected by February 2025. Full trial results are anticipated to be analyzed and submitted for publication by March 2025. Secondary analyses of data will be subsequently published. CONCLUSIONS: This trial tests an accessible and low-cost exercise program that leverages principles of high-intensity exercise to provide a convenient program for children with physical disabilities. Knowledge obtained from this study will inform the development of a larger trial for improving the cardiometabolic health, cardiorespiratory fitness, and well-being of children with physical disabilities. TRIAL REGISTRATION: ClinicalTrials.gov NCT05619211; https://clinicaltrials.gov/study/NCT05619211. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/56499.
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BACKGROUND: Adolescents with disabilities experience alarmingly higher rates of depression and isolation than peers without disabilities. There is a need to identify interventions that can improve mental health and isolation among this underserved population. Innovations in virtual reality (VR) gaming "standalone" headsets allow greater access to immersive high-quality digital experiences, due to their relatively low cost. OBJECTIVE: This study had three purposes, which were to (1) examine the preliminary effects of a low-cost, home-based VR multiplayer recreation and socialization on depression, socialization, and loneliness; (2) quantify the acceptability of the program as measured by participant adherence, total play time, and exercise time; and (3) identify and describe behavioral mechanisms that affected participant engagement. METHODS: This was a single-group, pre- to postdesign trial. The intervention was conducted at home. Participants were recruited from a children's hospital. The intervention lasted 4 weeks and included 2×1-hour sessions per week of supervised peer-to-peer gaming. Participants used the Meta Quest 2 headset to meet peers and 2 coaches in a private party held digitally. Aim 1 was evaluated with the Children's Depression Inventory 2 Short Form and the University of California, Los Angeles Loneliness Scale 20 items, which are measures of social isolation and loneliness, respectively. Aim 2 was evaluated through the following metrics: participant adherence, the types of games played, friendship building and playtime, and program satisfaction and enjoyment. RESULTS: In total, 12 people enrolled (mean age 16.6, SD 1.8 years; male: n=9 and female: n=3), and 8 people completed the program. Mean attendance for the 8 participants was 77% (49 sessions of 64 total possible sessions; mean 6, SD 2 sessions). A trend was observed for improved Children's Depression Inventory 2 Short Form scores (mean preintervention score 7.25, SD 4.2; mean postintervention score 5.38, SD 4.1; P=.06; effect size=0.45, 95% CI -0.15 to 3.9), but this was not statistically significant; no difference was observed for University of California, Los Angeles Loneliness Scale 20 items scores. Most participants (7/8, 88%) stated that they became friends with a peer in class; 50% (4/8) reported that they played with other people. Participants reported high levels of enjoyment and satisfaction with how the program was implemented. Qualitative analysis resulted in 4 qualitative themes that explained behavioral mechanisms that determined engagement in the program. CONCLUSIONS: The study findings demonstrated that a brief VR group program could be valuable for potentially improving mental health among adolescents with physical disabilities. Participants built friendships with peers and other players on the web, using low-cost consumer equipment that provided easy access and strong scale-up potential. Study findings identified factors that can be addressed to enhance the program within a larger clinical trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT05259462; https://clinicaltrials.gov/study/NCT05259462. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/42651.
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BACKGROUND: Adolescents with physical disabilities have higher rates of mental health conditions and issues than adolescents without disabilities, and this disparity was exacerbated by the onset of the COVID-19 pandemic. They also have limited access to on-site programs and nearby peers. OBJECTIVE: This pilot aims to investigate the potential effects of a low-dose multiplayer virtual reality telegaming program on depression, socialization, and loneliness among a cohort of children with physical disabilities. A secondary aim is to describe feasibility metrics, namely, recruitment and adherence rates and perceived program enjoyment and satisfaction. The tertiary aim is to describe behavioral mechanisms that affect participant adherence and social participation in the classes. METHODS: This study is a single-group pre- and posttest-designed trial. A single cohort of 12 children with physical disabilities will pilot a 1-month program that includes 2 supervised 1-hour sessions per week of group-based exergaming. Participants will complete questionnaires before and after the program. The primary aim measures will include the Children's Depression Inventory 2 Short Form, a measure of feelings of depression, and the UCLA Loneliness Scale, a measure of both loneliness and social isolation. Secondary aim measures will include three posttest Likert scale questionnaires: perceived program enjoyment, program satisfaction, and satisfaction with multiplayer experiences. At postintervention or dropout, participants will undergo semistructured interviews to identify behavioral mechanisms that underlie participation. Data will be reported descriptively and be supported by t tests as appropriate. RESULTS: Recruitment procedures started in July 2022. All data are expected to be collected by January 2023. Full trial results are expected to be published by March 2023. Secondary analyses of data will be subsequently published. CONCLUSIONS: This trial tests a peer-to-peer virtual reality telegaming program that includes a completely remote enrollment, assessment, and intervention protocol. This program is accessible and short in duration and frequency, allowing it to be integrated into other interventions. Knowledge obtained from this study will inform the development of a larger trial for improving the mental health and well-being of adolescents with physical disabilities. TRIAL REGISTRATION: ClinicalTrials.gov NCT05259462; https://clinicaltrials.gov/ct2/show/NCT05259462. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/42651.
RESUMEN
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.
RESUMEN
BACKGROUND: Adolescents with cerebral palsy (CP) who have mobility limitations have almost no access to inexpensive and enjoyable home-based programs that can be disseminated on a large scale to help them independently manage their health through participation in leisure-time physical activity (LTPA). OBJECTIVE: The primary aim of this study was to determine the preliminary efficacy of the early adoption phase of an adult Movement-to-Music (M2M) program with behavioral telecoaching for increasing LTPA and activity participation compared with a waitlist control group in adolescents with CP. The secondary aim was to explore the effects of the program on perceived levels of pain and fatigue. The tertiary aim was to qualitatively evaluate the factors that influenced adherence and develop a theory that would inform the development of a more targeted M2M telehealth program for this group. METHODS: This randomized controlled trial piloted a 4-week M2M program with weekly behavioral telecoaching among 58 adolescents with CP who walked or used wheelchairs. The participants were randomized into one of 2 groups: M2M or control, which maintained their daily activities. M2M included videos that participants were asked to complete 3 times each week at home (asynchronous training). Adherence to video minutes was objectively measured using cloud-based analytics. Changes in activity and LTPA participation were measured before and after the intervention using the Children's Assessment of Participation and Enjoyment total domain scores and active physical recreation domain scores, respectively. Perceived pain and fatigue were measured using the National Institutes of Health Neuro-QoL short forms. The changes in scores were compared between the groups using analysis of covariance. A grounded theory approach was used to analyze one-on-one interviews, coaching notes, and feedback surveys. RESULTS: A total of 58 people were enrolled, of which 49 (84%) completed the primary outcome follow-up assessment. The mean adherence to the prescribed exercise video minutes across all 4 weeks was 68%, starting from 90% in week 1 and gradually declining to 43% in week 4. Mean adherence to coaching calls was 91%. Analysis of covariance revealed a statistically significant difference between the pre- to postchange scores for Children's Assessment of Participation and Enjoyment Active Physical Recreation-Intensity domain scores in favor of the intervention group (F1,47=8.76; P=.005; effect size=0.17, also known as volume of LTPA). The qualitative findings highlighted 5 critical factors that influenced participants' adherence to the program: caregiver support, video elements, suitable exercises, music, and behavioral coaching. CONCLUSIONS: This project determined that adolescents with CP responded well to an M2M telehealth program that could enhance their LTPA levels. This paper describes a theory in which adherence to a telehealth LTPA program can be optimized through functional and age-specific modifications for adolescents with CP. TRIAL REGISTRATION: ClinicalTrials.gov NCT04264390; https://clinicaltrials.gov/ct2/show/NCT04264390.
RESUMEN
BACKGROUND: Youth with cerebral palsy do not have enjoyable, accessible, and scalable exercise options that can empower them to independently maintain their cardiometabolic health. OBJECTIVE: The primary aim is to examine the preliminary efficacy of a 12-week home-based virtual reality tele-exergaming intervention on several indicators of cardiometabolic health in youth with cerebral palsy compared to the wait list control. A secondary aim is to describe feasibility metrics, namely, recruitment, retention, and adherence rates; perceived enjoyment; intervention safety; and management issues. The tertiary aim is to generate a theory that reveals critical behavioral mechanisms of adherence to tele-exergaming. METHODS: In this parallel group design randomized controlled trial, 34 inactive youths with cerebral palsy are randomly allocated to one of two groups: a group that immediately receives 12 weeks of virtual reality exergaming with tele-physical education or a wait list control group that undergoes their habitual activity for 12 weeks. Participants are recruited from a Children's Hospital and community network. At baseline (week 0), week 6, and week 12, high sensitivity C-reactive protein and blood insulin, hemoglobin A1c, triglycerides, cholesterol, and pressure are measured by the youth and a caregiver at home using a blood spot test kit and blood pressure cuff. They will also self-measure their lung function and body weight using a peak flow meter and bathroom scale, respectively. Collections are supervised by research staff via videoconference. Changes in outcomes are compared between and within groups using exploratory statistical analyses and descriptive statistics. At postintervention or dropout, participants will undergo semistructured interviews to identify behavioral mechanisms that underly participation. RESULTS: Recruitment procedures started in June 2022. All data are expected to be collected by October 2023. Full trial results are expected to be published by February 2024. Secondary analyses of data will be subsequently published. CONCLUSIONS: This trial tests an innovative serious exergaming virtual reality program that includes a completely remote enrollment, assessment, and intervention tele-protocol. The knowledge obtained will inform the development of a larger effectiveness trial for improving the health and well-being of youth with cerebral palsy. TRIAL REGISTRATION: ClinicalTrials.gov NCT05336227; https://clinicaltrials.gov/ct2/show/NCT05336227. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/40708.
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BACKGROUND: The impact of COVID-19 on adolescents with cerebral palsy (CP) and their families is underinvestigated, particularly in the Southeastern United States. OBJECTIVE/HYPOTHESIS: The objective of this study was to examine the impact of COVID-19 on lifestyle activities, general and mental health, and basic needs among a cohort of adolescents with CP in the Southeast U.S. The second purpose was to identify key factors that impacted their lifestyles. METHODS: This was a cross-sectional survey of adolescents with CP (aged 10-19 years) who completed a child-modified version of the Coronavirus Disability Survey. Health and behavior items were associated with the perceived lifestyle impact of COVID-19. RESULTS: A total of 101 respondents completed the survey (mean age: 14 ± 2 years). Respondents reported minimal to no change in general health since the COVID-19 outbreak. Basic needs were met for most families. Nearly all participants (94.1%) reported a mental health concern that resulted from COVID-19: 32.7% felt down or depressed; 47.5% felt little pleasure in doing things; and 64.4% felt isolated. Moreover, 74.3% reported decreased socialization, 51.5% reported reduced exercise participation, and 43.6% reported difficulties in obtaining medical care. Most participants (90.1%) were negatively affected by COVID-19, and key associated factors were reduced interactions with friends and family (p = 0.001), exercise participation (p = 0.016), interest in doing things (p = 0.005), worsened depression (p = 0.015), increased isolation from others (p = 0.02) and at home (p = 0.006), technological communication (p = 0.00), and virus exposure (p = 0.008). CONCLUSIONS: Study findings highlight problem areas that warrant urgent intervention among adolescents with CP located within the Southeast U.S.
