About this trial
This phase II RCT evaluates the efficacy of a telehealth-delivered extended reality (XR) exergaming intervention on physical activity, cardiometabolic health, and physical fitness in physically inactive children with cerebral palsy (ages 10 to 17). A total of 130 participants will be randomized to either a 12-week XR exergaming intervention with behavioral coaching or a non-intervention control group, followed by a 24-week sustainability phase. Aim 1 examines immediate and sustained effects on physical activity levels. Aim 2 tests effects on cardiometabolic health indicators including blood lipids, blood pressure, and glycemic markers. Aim 3 explores effects on physical fitness and perceived health. All procedures are conducted remotely via telehealth.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
medical diagnosis of cerebral palsy
between the ages of 10-17 years (10 years of age is the minimum requirement of the Meta Quest 3s headset, as noted by the manufacturer)
physician clearance to participate in moderate-intensity exercise
access to a Wi-Fi Internet connection in the home
Disqualifiers
physically active (defined as ≥150 minutes per week of moderate-to-vigorous intensity exercise in a typical week)
prone to photosensitive seizures
a classification of GMFCS level V, which we have found to preclude the ability to use the Oculus Quest hand-held controllers
complete blindness or deafness
Trial design
Parallel
Treatments tested in this trial
Extended Reality Exergaming
BehavioralSeated arm exercise using an extended reality headset for 36 weeks.
Treatment groups
Trial outcomes
Primary outcomes
Godin Leisure Time Exercise Questionnaire
The GLTEQ is a 7-day recall survey. The GLTEQ will be scored using a health contribution (HC) score, which equates an HC score of ≥24 to the minimum aerobic guideline of 150 mins/week of moderate exercise.
Daily Step Count
Steps per day, captured using the Polar Unite wrist watch.
Secondary outcomes
Changes in C-reactive Protein (hsCRP)
hsCRP (mg/L) is a critical marker of inflammation that contributes to pro-inflammatory and pro-thrombotic elements of CVD risk. A single hsCRP measure is a strong predictor of myocardial infarction or coronary heart disease mortality, and several other diseases of the circulatory system in people without a history of such conditions.
Changes in Hemoglobin A1C
HbA1C (mmol/mol) measures mean hemoglobin glycation over the previous three months.
Changes in Fasting Insulin
High fasting insulin indicates the presence of insulin resistance. Exercise interventions can expect a small beneficial change in fasting insulin levels after 1-month of training.
Changes in Fasting Triglycerides
A triglyceride level \>150 mg/dL, is largely supported as an indicator of CVD risk. Exercise interventions can expect a small beneficial change in triglyceride levels following 1-month of training, even among people with normal triglyceride levels.
Sponsors and contacts
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