An interventional study of Virtual reality physical activity health promotion intervention in Physical Activity, Intellectual Disabilities and Cardiovascular Health, sponsored by Michigan State University. Not yet recruiting. Open to participants aged 11 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Michigan State University · Not applicable, Interventional, and Prevention
Adolescents with intellectual disabilities (ID) face significant health issues, particularly in managing chronic conditions such as cardiovascular (CV) health risks. These issues are exacerbated by limited physical activity (PA), health literacy challenges, and a lack of evidence-based health interventions. This project aims to address these gaps by engaging adolescents with ID and their stakeholders supporting ID as co-researchers to design, adapt, and pilot-test a virtual reality (VR)-based PA intervention tailored to their needs. The long-term goal is to dismantle factors to improve health outcomes for adolescents with ID through innovative, collaborative research that enhances health literacy, increases PA, and lowers CV health risks. The objectives of this study will address three specific aims: 1) adapt and validate research instruments by collaborating with adolescents with ID and their ID stakeholders to incorporate common language in measures for assessing health outcomes; 2) evaluate and select VR-based PA programs by engaging co-researchers in identifying effective VR exergame interventions for improving health outcomes through PA; and 3) pilot-test the VR PA intervention, which incorporates peer support. We will assess feasibility, acceptability, and preliminary efficacy of our 16-week VR exergame PA intervention using co-adapted measures and biologic CV risk measures. A quasi-experimental mixed-methods approach will be used, guided by our Logic Model. Preliminary evidence highlights the potential of interactive, technology-driven PA to address CV risks while fostering peer engagement and optimal self-efficacy to manage health. The expected outcomes are: 1) validated measures through greater health literacy, and 2) a co-designed intervention to reduce CV risks that helps adolescents with ID to take an active role in their health. By addressing critical gaps in health literacy, self-efficacy, and PA, this work advances healthcare practices and supports long-term improvements in public health.
387 studies on the registry are indexed under Intellectual Disability; 105 are open to participants now.
This study's planned enrollment of 77 is above the median of 58 across 248 interventional studies indexed under Intellectual Disability.
Browse Intellectual Disability studies →Michigan State University is the lead sponsor of 143 studies on the registry; 27 are open to participants now.
Compared within Intellectual Disability, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Activity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Inclusion Criteria: The study will be offered to adolescents with ID who meet eligibility criteria and provide assent and parental consent. Adolescents aged 11-17 years will be eligible if: 1) diagnosed with mild to moderate ID, 2) able to communicate through spoken language or use of augmentative and alternative communication (AAC), 3) understand spoken English, 4) absence of medical to PA and playing VR games, 5) parent/guardian agrees to attend virtual meetings and adolescents, and 6) internet access.
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Exclusion Criteria:
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single arm study participants will be asked to utilize a VR exercise program and complete pre/post surveys
Behavioral: Virtual reality physical activity health promotion intervention
The intervention will be delivered via home setting of the study participant (adolescent with ID). Baseline Home Visit; week 1: All pre-intervention baseline measures will be obtained, accelerometer will be fitted and applied. Home Visit 2; week 2: The participant will utilize the VR technology three sessions per week (weeks 3-16) for approximately 10 minutes per exercise session following instructions on use. Visit 3; Virtual; week 4: One of the three VR sessions per week will be virtual peer group interactions, guided by study staff. Virtual peer groups will utilize the VR technology together for at least one session of the three sessions per week for approximately 10 minutes per exercise session during weeks 4-16. Educational materials include: visual supports to guide VR use along with study team's contact information throughout the intervention. Study Completion Home Visit; after week 15: Follow up data collection. Virtual Week 16; Optional: Qualitative follow-up data collection.
Physical Activity
Measure of number of steps per day, minutes of moderate/vigorous physical activity per week utilizing an ActiGraph.
Time frame: Baseline and at 16 weeks
Feasibility of Intervention
4-item, validated measure to evaluate the feasibility of immersive VR intervention.
Time frame: At 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Acceptability of Intervention
4-item, validated measure to evaluate the acceptability of immersive VR intervention
Time frame: At 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Virtual Reality Symptoms
4-item, to measure the symptoms one experiences while or after being in a VR environment. Symptoms that have been associated with VR use (general discomfort, fatigue, eyestrain, difficulty focusing, headache, fullness of head, blurred vision, dizziness with eyes closed, vertigo)
Time frame: At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Multidimensional Scale of Perceived Social Support (MSPSS)
12-item, validated measure to assess perceptions of social support adequacy from three sources: family, friends, and significant other (subscales)
Time frame: At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Multidimensional Self-efficacy for Exercise (MSES)
9-item, measure to assess three behavioral domains (i.e., task efficacy, coping efficacy, scheduling efficacy) that relate to exercise behavior among individuals and exercise contexts. The three behavioral domains are useful in determining the dimensions that influence exercise in a particular population segment
Time frame: At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Body Mass Index (BMI)
Measure of estimated body fat based on a person's height and weight. Portable stadiometer and scale use to measure height and weight
Time frame: At baseline, 16 weeks
Waist circumference
Measure of the distance around a person's waist as a health indicator to assess risk of excess body fat for developing a chronic condition. Measuring tape utilized
Time frame: At baseline, 16 weeks
Calories Burned
Measure of the rate at which an individual burns calories based on the height, weight, age, and gender entered into an individual's app account. Fitbit wearable activity monitor and mobile app utilized
Time frame: At 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Heart Rate
Measure of number of individual's heart beats per minute (bpm) with various activities. Fitbit wearable activity monitor and mobile app utilized
Time frame: At 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Active Zone Minutes per Day
Measure of the time an individual spends in different heart rate zones. Fitbit wearable activity monitor and mobile app utilized
Time frame: At 4 weeks, 8 weeks, 12 weeks, and 16 weeks
No study locations are listed for this record.
Plan to share: Yes
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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