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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05336227
• Other study ID #: 1R03HD107598-01
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: June 1, 2022
• Est. completion date: February 28, 2025

Study information

• Verified date: June 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 34
• Est. completion date: February 28, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Behavioral:
• Virtual Reality Exergaming
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.

Locations

Country	Name	City	State
United States	Children's Hospital of Alabama	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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, Week 6, Week 12
Primary	Changes in Hemoglobin A1C	HbA1C (mmol/mol) measures mean hemoglobin glycation over the previous three months.	Week 0, Week 6, Week 12
Primary	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, Week 6, Week 12
Primary	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, Week 6, Week 12
Primary	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, Week 6, Week 12
Primary	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, Week 6, Week 12
Primary	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, Week 6, Week 12
Primary	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, Week 6, Week 12
Primary	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, Week 6, Week 12
Primary	Changes in body weight	Body weight measured in lbs using a off-the-shelf bathroom scale.	Week 0, Week 6, Week 12
Primary	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, Week 6, Week 12
Secondary	Total intervention play time	Total minutes of playtime recorded by mobile app and uploaded to research staff by participants.	Weeks 1-12
Secondary	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.	Weeks 1-12
Secondary	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.	Weeks 1-12
Secondary	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.	Weeks 1-12
Secondary	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.	Week 13