search
Back to results

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

Primary Purpose

Cerebral Palsy

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality Exergaming
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cerebral Palsy focused on measuring physical activity, exercise, telehealth

Eligibility Criteria

13 Years - 24 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. medical diagnosis of cerebral palsy
  2. 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
  3. physician clearance to participate
  4. access to a Wi-Fi Internet connection in the home via mobile phone or tablet computer
  5. a caregiver to support the child

Exclusion Criteria:

  1. physically active (defined as >150 minutes per week of moderate-to-vigorous intensity exercise in a typical week)
  2. 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
  3. complete blindness or deafness.
  4. contraindications to exercise based on the American College of Sports Medicine (ACSM) guidelines

Sites / Locations

  • Children's Hospital of AlabamaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Immediate Start - Virtual Reality Exergaming

Wait-list Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
Changes in body weight
Body weight measured in lbs using a off-the-shelf bathroom scale.
Changes in lung capacity
Lung capacity will be measured via peak expiratory flow rate (PEF; units: L/min) using a spirometer at the home.

Secondary Outcome Measures

Total intervention play time
Total minutes of playtime recorded by mobile app and uploaded to research staff by participants.
Adherence to the exercise intervention prescription
Moderate exercise minutes met (percent of prescription achieved), number of weeks where the ≥150 minutes of moderate intensity exercise per week was achieved, as indicated by participants in their exercise journal. The number of weeks will be divided by 12 to obtain a percentage value of weeks where the moderate exercise prescription was met.
Compliance to the intervention coaching calls
Coaching call compliance, the number of coaching sessions completed, converted into a percentage by dividing by the total possible.
Compliance to the remote data collections
Data collection compliance, the number of videoconference data collection sessions completed, converted into a percentage by dividing by the total possible.
Participants perceptions of completing the intervention
After the intervention, participants will undergo a one-on-one semi-structured interview phone call. The purpose of the call is to receive feedback on how to improve the intervention and understand behavioral mechanisms that contributed to exercise adherence.

Full Information

First Posted
April 13, 2022
Last Updated
February 10, 2023
Sponsor
University of Alabama at Birmingham
search

1. Study Identification

Unique Protocol Identification Number
NCT05336227
Brief Title
Telehealth Virtual Reality Gaming on Cardiometabolic Health Among Youth With Cerebral Palsy
Official Title
A Pilot Trial of Telehealth Active Video Gaming Using Immersive Virtual Reality on Cardiometabolic Health Among Youth With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
physical activity, exercise, telehealth

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
One group that immediately receives the intervention. Another group that waits before receiving the same intervention.
Masking
Outcomes Assessor
Masking Description
The outcomes assessors will be blinded to group allocation (data entry and analysis personnel).
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate Start - Virtual Reality Exergaming
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait-list Control
Arm Type
No Intervention
Arm Description
Maintain habitual physical activity levels for 12 weeks, before receiving the same intervention. Maintain normal eating/nutritional behaviors.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Exergaming
Intervention Description
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 Outcome Measure Information:
Title
Changes in C-reactive protein (hsCRP)
Description
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
Title
Changes in Hemoglobin A1C
Description
HbA1C (mmol/mol) measures mean hemoglobin glycation over the previous three months.
Time Frame
Week 0, Week 6, Week 12
Title
Changes in fasting insulin
Description
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
Title
Changes in fasting triglycerides
Description
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
Title
Changes in high-density lipoprotein
Description
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.
Time Frame
Week 0, Week 6, Week 12
Title
Changes in low-density lipoprotein
Description
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.
Time Frame
Week 0, Week 6, Week 12
Title
Changes in total cholesterol
Description
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.
Time Frame
Week 0, Week 6, Week 12
Title
Changes in resting systolic blood pressure
Description
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.
Time Frame
Week 0, Week 6, Week 12
Title
Changes in resting diastolic blood pressure
Description
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.
Time Frame
Week 0, Week 6, Week 12
Title
Changes in body weight
Description
Body weight measured in lbs using a off-the-shelf bathroom scale.
Time Frame
Week 0, Week 6, Week 12
Title
Changes in lung capacity
Description
Lung capacity will be measured via peak expiratory flow rate (PEF; units: L/min) using a spirometer at the home.
Time Frame
Week 0, Week 6, Week 12
Secondary Outcome Measure Information:
Title
Total intervention play time
Description
Total minutes of playtime recorded by mobile app and uploaded to research staff by participants.
Time Frame
Weeks 1-12
Title
Adherence to the exercise intervention prescription
Description
Moderate exercise minutes met (percent of prescription achieved), number of weeks where the ≥150 minutes of moderate intensity exercise per week was achieved, as indicated by participants in their exercise journal. The number of weeks will be divided by 12 to obtain a percentage value of weeks where the moderate exercise prescription was met.
Time Frame
Weeks 1-12
Title
Compliance to the intervention coaching calls
Description
Coaching call compliance, the number of coaching sessions completed, converted into a percentage by dividing by the total possible.
Time Frame
Weeks 1-12
Title
Compliance to the remote data collections
Description
Data collection compliance, the number of videoconference data collection sessions completed, converted into a percentage by dividing by the total possible.
Time Frame
Weeks 1-12
Title
Participants perceptions of completing the intervention
Description
After the intervention, participants will undergo a one-on-one semi-structured interview phone call. The purpose of the call is to receive feedback on how to improve the intervention and understand behavioral mechanisms that contributed to exercise adherence.
Time Frame
Week 13

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raven Young
Phone
205.638.6445
Email
ravensamuel@uabmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Byron Lai, PhD
Phone
205.638.9790
Ext
8-9725
Email
blai@uabmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Byron Lai, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Byron Lai, PhD
Phone
205-200-1724
Email
byronlai@uab.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data will be submitted into the NICHD Data and Specimen Hub (DASH). Intellectual property and data generated under this project will be administered in accordance with both University and NIH policies, including the NIH Data Sharing Policy and Implementation Guidance under notice NOT-OD-03-032 (released February 26, 2003)
IPD Sharing Time Frame
Beginning 3 months after publication and ending 5 years after publication.
Citations:
PubMed Identifier
35976192
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs