Leveraging Extended Reality Exergaming and Telehealth to Improve Physical Activity and Health in Children With Disabilities

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age10-17
SponsorUniversity of Alabama at Birmingham

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Extended Reality Exergaming

    Behavioral

    Seated arm exercise using an extended reality headset for 36 weeks.

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Extended Reality Gaming (XRG)Experimental treatment 1 intervention
Group B: Non-intervention ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
week 0, week 6, week 12, week 24, week 36
2

Daily Step Count

Steps per day, captured using the Polar Unite wrist watch.

Time frame
weeks 0-36

Secondary outcomes

1

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.

Time frame
week 0, week 6, week 12, week 24, week 36
2

Changes in Hemoglobin A1C

HbA1C (mmol/mol) measures mean hemoglobin glycation over the previous three months.

Time frame
week 0, week 6, week 12, week 24, week 36
3

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.

Time frame
week 0, week 6, week 12, week 24, week 36
4

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.

Time frame
week 0, week 6, week 12, week 24, week 36

Other outcomes

Sponsors and contacts

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