Clinical trial NCT05336227: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cerebral Palsy
Keywords: physical activity
exercise
telehealth
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2022-04-20
Enrollment: 32
Sex: ALL
Minimum age (years): 13
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group that immediately receives the intervention. Another group that waits before receiving the same intervention.
Primary purpose: PREVENTION

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).

Eligibility criteria: 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

Primary outcomes:
measure: Changes in C-reactive Protein (hsCRP)
timeFrame: Week 0
measure: Changes in Hemoglobin A1C
timeFrame: Week 0
measure: Changes in Fasting Insulin
timeFrame: Week 0
measure: Changes in Fasting Triglycerides
timeFrame: Week 0
measure: Changes in High-density Lipoprotein
timeFrame: Week 0
measure: Changes in Low-density Lipoprotein
timeFrame: Week 0
measure: Changes in Total Cholesterol
timeFrame: Week 0
measure: Changes in Resting Systolic Blood Pressure
timeFrame: Week 0
measure: Changes in Resting Diastolic Blood Pressure
timeFrame: Week 0
measure: Changes in Body Weight
timeFrame: Week 0
measure: Changes in Lung Capacity
timeFrame: Week 0
measure: Changes in C-reactive Protein (hsCRP)
timeFrame: Week 7
measure: Changes in C-reactive Protein (hsCRP)
timeFrame: Week 13
measure: Changes in Hemoglobin A1C
timeFrame: Week 7
measure: Changes in Hemoglobin A1C
timeFrame: Week 13
measure: Changes in Fasting Insulin
timeFrame: Week 7
measure: Changes in Fasting Insulin
timeFrame: Week 13
measure: Changes in Fasting Triglycerides
timeFrame: Week 7
measure: Changes in Fasting Triglycerides
timeFrame: Week 13
measure: Changes in High-density Lipoprotein
timeFrame: Week 7
measure: Changes in High-density Lipoprotein
timeFrame: Week 13
measure: Changes in Total Cholesterol
timeFrame: Week 7
measure: Changes in Total Cholesterol
timeFrame: Week 13
measure: Changes in Low-density Lipoprotein
timeFrame: Week 7
measure: Changes in Low-density Lipoprotein
timeFrame: Week 13
measure: Changes in Resting Systolic Blood Pressure
timeFrame: Week 7
measure: Changes in Resting Systolic Blood Pressure
timeFrame: Week 13
measure: Changes in Resting Diastolic Blood Pressure
timeFrame: Week 7
measure: Changes in Resting Diastolic Blood Pressure
timeFrame: Week 13
measure: Changes in Body Weight
timeFrame: Week 7
measure: Changes in Body Weight
timeFrame: Week 13
measure: Changes in Lung Capacity
timeFrame: Week 7
measure: Changes in Lung Capacity
timeFrame: Week 13
Secondary outcomes:
measure: Total Intervention Play Time
timeFrame: Weeks 1-12
measure: Adherence to the Exercise Intervention Prescription
timeFrame: Weeks 1-12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's Hospital of Alabama
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Byron Lai, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.