A Pilot Trial of Telehealth Active Video Gaming Using Immersive Virtual Reality on Cardiometabolic Health Among Youth With Cerebral Palsy
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 32
- Locations
- 2
- Primary Endpoint
- Changes in C-reactive Protein (hsCRP)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
The outcomes assessors will be blinded to group allocation (data entry and analysis personnel).
Eligibility Criteria
- Ages
- 13 Years to 24 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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.
Changes in Hemoglobin A1C
Time Frame: Week 13
HbA1C (mmol/mol) measures mean hemoglobin glycation over the previous three months.
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.
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.
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.
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.
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.
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.
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.
Changes in Body Weight
Time Frame: Week 13
Body weight measured in lbs using a off-the-shelf bathroom scale.
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
- Total Intervention Play Time(Weeks 1-12)
- Adherence to the Exercise Intervention Prescription(Weeks 1-12)
Investigators
Byron Lai
Assistant Professor
University of Alabama at Birmingham