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Completed

NCT Number: NCT05336227

Telehealth Virtual Reality Gaming on Cardiometabolic Health Among Youth With Cerebral Palsy

The primary purpose of this study is to examine the preliminary efficacy of 12-weeks of home-based exercise using consumer available virtual reality gaming technology, compared with a 12 week wait-list control group. The secondary purpose is to understand behavioral mechanisms that explain participation in exergaming through semi-structured interviews with participants from both groups at post-intervention or dropout.

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Key information

Conditions

Cerebral Palsy Behavior Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Motor Activity Nervous System Diseases

Age range

13 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Children's Hospital of Alabama

Birmingham, Alabama, 35233, United States

About this study

Youth with cerebral palsy (YwCP) do not have adequate exercise options that empower them to independently maintain their cardiometabolic health and, thus, live inactive, sedentary lifestyles that place them at substantially higher risk for cardiovascular disease, related conditions (e.g., hypercholesterolemia, diabetes, and hypertension), and mortality than the general population. No randomized controlled trial (RCT) has demonstrated clinically meaningful improvements in cardiometabolic health in people with cerebral palsy.

VR gaming delivered via telehealth may be an optimal method of promoting sustainable exercise behavior among large groups of youth. Home-based telehealth programs that incorporate 'virtual' behavioral coaching (tele-coaching) are a desirable approach for promoting non-supervised, exercise behavior among people with disabilities who do not have convenient access to community programs. The addition of behavioral coaching strategies such as goal-setting, confidence building, setting reasonable expectations, and understanding benefits, underpinned by theory such as the Social Cognitive Theory (Bandura, 2004), have been found to enhance the likelihood that people engage in and sustain a behavior.

Therefore, this study hypothesizes that 3-months of tele-monitored VR exergaming with behavioral coaching will result in strong adherence to moderate-intensity exercise and greater changes in key indicators of cardiometabolic health in YwCP, compared with a wait-list control group that maintains habitual activity (before receiving the intervention).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • medical diagnosis of cerebral palsy
  • between the ages of 13-24 years to accommodate the World Health Organization definition of youth and the minimum age of 13 years specified by the Quest
  • physician clearance to participate
  • access to a Wi-Fi Internet connection in the home via mobile phone or tablet computer
  • a caregiver to support the child

Exclusion criteria

  • physically active (defined as >150 minutes per week of moderate-to-vigorous intensity exercise in a typical week)
  • cannot use their arms for exercise or 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.
  • contraindications to exercise based on the American College of Sports Medicine (ACSM) guidelines

Treatment and study plan

Virtual Reality Exergaming

Behavioral

The VR intervention will include home-based exercise using the Oculus Quest, a heart rate monitor (Polar OH1), BP cuff, and mobile application. The games will include rhythmic movements to music and sport/recreation activities that elicit high energy expenditure. Participants will be instructed to reach 150 minutes per week of moderate-exercise in week 1 and maintain this volume across the 12-week intervention. The intervention will include behavioral, physical education coaching through videoconference, which we refer to as Tele-PE. Tele-PE will aim to enhance adherence, provide basic exercise knowledge, and increase mastery playing the games. Calls will last 15 minutes, and be provided weekly in month 1, bi-weekly in month 2, and one call at the end of month 3.

Primary outcomes

  1. Changes in C-reactive Protein (hsCRP)

    Time frame: Week 0

    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.

  2. Changes in Hemoglobin A1C

    Time frame: Week 0

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

  3. Changes in Fasting Insulin

    Time frame: Week 0

    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.

  4. Changes in Fasting Triglycerides

    Time frame: Week 0

    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.

  5. Changes in High-density Lipoprotein

    Time frame: Week 0

    High-density lipoprotein (HDL; mg/dL) cholesterol is a predictor of future CVD among young and middle-aged people. Exercise interventions can expect a small effect after 1-month of training.

  6. Changes in Low-density Lipoprotein

    Time frame: Week 0

    Low-density lipoprotein (LDL; mg/dL) cholesterol is a predictor of future CVD among young and middle-aged people. Exercise interventions can expect a small effect after 1-month of training.

  7. Changes in Total Cholesterol

    Time frame: Week 0

    Total cholesterol (mg/dL) is a predictor of future CVD among young and middle-aged people. Exercise interventions can expect a small effect after 1-month of training.

  8. Changes in Resting Systolic Blood Pressure

    Time frame: Week 0

    Elevated blood pressure (mmHg) during childhood and adolescents is associated with intermediate markers and hard outcomes of CVD in adulthood. Moderate-intensity exercise is negatively associated with blood pressure. Small changes in blood pressure can occur from as early as 1-month of endurance training.

  9. Changes in Resting Diastolic Blood Pressure

    Time frame: Week 0

    Elevated blood pressure (mmHg) during childhood and adolescents is associated with intermediate markers and hard outcomes of CVD in adulthood. Moderate-intensity exercise is negatively associated with blood pressure. Small changes in blood pressure can occur from as early as 1-month of endurance training.

  10. Changes in Body Weight

    Time frame: Week 0

    Body weight measured in lbs using a off-the-shelf bathroom scale.

  11. Changes in Lung Capacity

    Time frame: Week 0

    Lung capacity will be measured via peak expiratory flow rate (PEF; units: L/min) using a spirometer at the home.

  12. Changes in C-reactive Protein (hsCRP)

    Time frame: Week 7

    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.

  13. Changes in C-reactive Protein (hsCRP)

    Time frame: Week 13

    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.

  14. Changes in Hemoglobin A1C

    Time frame: Week 7

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

  15. Changes in Hemoglobin A1C

    Time frame: Week 13

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

  16. Changes in Fasting Insulin

    Time frame: Week 7

    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.

  17. Changes in Fasting Insulin

    Time frame: Week 13

    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.

  18. Changes in Fasting Triglycerides

    Time frame: Week 7

    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.

  19. Changes in Fasting Triglycerides

    Time frame: Week 13

    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.

  20. Changes in High-density Lipoprotein

    Time frame: Week 7

    High-density lipoprotein (HDL; mg/dL) cholesterol is a predictor of future CVD among young and middle-aged people. Exercise interventions can expect a small effect after 1-month of training.

  21. Changes in High-density Lipoprotein

    Time frame: Week 13

    High-density lipoprotein (HDL; mg/dL) cholesterol is a predictor of future CVD among young and middle-aged people. Exercise interventions can expect a small effect after 1-month of training.

  22. Changes in Total Cholesterol

    Time frame: Week 7

    Total cholesterol (mg/dL) is a predictor of future CVD among young and middle-aged people. Exercise interventions can expect a small effect after 1-month of training.

  23. Changes in Total Cholesterol

    Time frame: Week 13

    Total cholesterol (mg/dL) is a predictor of future CVD among young and middle-aged people. Exercise interventions can expect a small effect after 1-month of training.

  24. Changes in Low-density Lipoprotein

    Time frame: Week 7

    Low-density lipoprotein (LDL; mg/dL) cholesterol is a predictor of future CVD among young and middle-aged people. Exercise interventions can expect a small effect after 1-month of training.

  25. Changes in Low-density Lipoprotein

    Time frame: Week 13

    Low-density lipoprotein (LDL; mg/dL) cholesterol is a predictor of future CVD among young and middle-aged people. Exercise interventions can expect a small effect after 1-month of training.

  26. Changes in Resting Systolic Blood Pressure

    Time frame: Week 7

    Elevated blood pressure (mmHg) during childhood and adolescents is associated with intermediate markers and hard outcomes of CVD in adulthood. Moderate-intensity exercise is negatively associated with blood pressure. Small changes in blood pressure can occur from as early as 1-month of endurance training.

  27. Changes in Resting Systolic Blood Pressure

    Time frame: Week 13

    Elevated blood pressure (mmHg) during childhood and adolescents is associated with intermediate markers and hard outcomes of CVD in adulthood. Moderate-intensity exercise is negatively associated with blood pressure. Small changes in blood pressure can occur from as early as 1-month of endurance training.

  28. Changes in Resting Diastolic Blood Pressure

    Time frame: Week 7

    Elevated blood pressure (mmHg) during childhood and adolescents is associated with intermediate markers and hard outcomes of CVD in adulthood. Moderate-intensity exercise is negatively associated with blood pressure. Small changes in blood pressure can occur from as early as 1-month of endurance training.

  29. Changes in Resting Diastolic Blood Pressure

    Time frame: Week 13

    Elevated blood pressure (mmHg) during childhood and adolescents is associated with intermediate markers and hard outcomes of CVD in adulthood. Moderate-intensity exercise is negatively associated with blood pressure. Small changes in blood pressure can occur from as early as 1-month of endurance training.

  30. Changes in Body Weight

    Time frame: Week 7

    Body weight measured in lbs using a off-the-shelf bathroom scale.

  31. Changes in Body Weight

    Time frame: Week 13

    Body weight measured in lbs using a off-the-shelf bathroom scale.

  32. Changes in Lung Capacity

    Time frame: Week 7

    Lung capacity will be measured via peak expiratory flow rate (PEF; units: L/min) using a spirometer at the home.

  33. Changes in Lung Capacity

    Time frame: Week 13

    Lung capacity will be measured via peak expiratory flow rate (PEF; units: L/min) using a spirometer at the home.

Secondary outcomes

  1. Total Intervention Play Time

    Time frame: Weeks 1-12

    Total minutes of playtime recorded by mobile app and uploaded to research staff by participants. Waitlist control data was not assessed for this outcome; data not collected.

  2. Adherence to the Exercise Intervention Prescription

    Time frame: Weeks 1-12

    Percentage of moderate exercise minutes met (percent of prescription achieved), as indicated by participants in their exercise logs. The number of moderate minutes per week achieved divided by 150. Waitlist control data was not assessed for this outcome; data not collected.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

A Pilot Trial of Telehealth Active Video Gaming Using Immersive Virtual Reality on Cardiometabolic Health Among Youth With Cerebral Palsy

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Apr 20, 2022
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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