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

NCT05336227 | Completed Phase 1 Results

• 2 other identifiers: 3000078331R03HD107598-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Palsy

Keywords

physical activity; exercise; telehealth

Outcome Measures

Primary Outcomes (33)

• 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.

  Week 0

• Changes in Hemoglobin A1C

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

  Week 0

• 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.

  Week 0

• 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.

  Week 0

• Changes in High-density Lipoprotein

  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.

  Week 0

• Changes in Low-density Lipoprotein

  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.

  Week 0

• Changes in Total Cholesterol

  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.

  Week 0

• Changes in Resting Systolic Blood Pressure

  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.

  Week 0

• Changes in Resting Diastolic Blood Pressure

  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.

  Week 0

• Changes in Body Weight

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

  Week 0

• Changes in Lung Capacity

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

  Week 0

• 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.

  Week 7

• 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.

  Week 13

• Changes in Hemoglobin A1C

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

  Week 7

• Changes in Hemoglobin A1C

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

  Week 13

• 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.

  Week 7

• 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.

  Week 13

• 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.

  Week 7

• 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.

  Week 13

• Changes in High-density Lipoprotein

  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.

  Week 7

• Changes in High-density Lipoprotein

  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.

  Week 13

• Changes in Total Cholesterol

  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.

  Week 7

• Changes in Total Cholesterol

  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.

  Week 13

• Changes in Low-density Lipoprotein

  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.

  Week 7

• Changes in Low-density Lipoprotein

  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.

  Week 13

• Changes in Resting Systolic Blood Pressure

  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.

  Week 7

• Changes in Resting Systolic Blood Pressure

  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.

  Week 13

• Changes in Resting Diastolic Blood Pressure

  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.

  Week 7

• Changes in Resting Diastolic Blood Pressure

  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.

  Week 13

• Changes in Body Weight

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

  Week 7

• Changes in Body Weight

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

  Week 13

• Changes in Lung Capacity

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

  Week 7

• Changes in Lung Capacity

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

  Week 13

Secondary Outcomes (2)

• Total Intervention Play Time

  Weeks 1-12

• Adherence to the Exercise Intervention Prescription

  Weeks 1-12

Study Arms (2)

Immediate Start - Virtual Reality Exergaming

EXPERIMENTAL

12 weeks of virtual reality active video gaming using immersive commercially available equipment, with adapted games for people to play in the seated position. Maintain normal eating/nutritional behaviors.

Behavioral: Virtual Reality Exergaming

Wait-list Control

NO INTERVENTION

Maintain habitual physical activity levels for 12 weeks, before receiving the same intervention. Maintain normal eating/nutritional behaviors.

Interventions

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.

Immediate Start - Virtual Reality Exergaming

Eligibility Criteria

• Age: 13 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Children's Hospital of Alabama

Birmingham, Alabama, 35233, United States

Location

Related Publications (1)

• Lai B, Davis D, Young R, Kimani-Swanson E, Wozow C, Wen H, Kim Y, Wilroy J, Rimmer J. The Effects of Virtual Reality Tele-exergaming on Cardiometabolic Indicators of Health Among Youth With Cerebral Palsy: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2022 Aug 17;11(8):e40708. doi: 10.2196/40708.

  PMID: 35976192 DERIVED

MeSH Terms

Conditions

Cerebral Palsy; Motor Activity

Interventions

Exergaming

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

The study sample was not statistically powered. Thus, findings should be interpreted with caution.

Results Point of Contact

• Title: Byron Lai
• Organization: University of Alabama at Birmingham

blai@uabmc.edu

205.638.9790

Study Officials

• Byron Lai, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessors will be blinded to group allocation (data entry and analysis personnel).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: One group that immediately receives the intervention. Another group that waits before receiving the same intervention.

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 20, 2022
• Study Start: June 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: February 11, 2025
• Last Updated: May 13, 2025
• Results First Posted: May 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 3 months after publication and ending 5 years after publication.

Locations

US (1)