Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 15, 2022
Date Accepted: Jul 21, 2022
The effects of virtual reality tele-exergaming on cardiometabolic indicators of health among youth with cerebral palsy: a pilot randomized controlled trial
ABSTRACT
Background:
Youth with cerebral palsy (YwCP) do not have enjoyable, accessible, and scalable exercise options that can empower them to independently maintain their cardiometabolic health.
Objective:
The primary aim is to examine the preliminary efficacy of 12-weeks of home-based virtual reality tele-exergaming on several indicators of cardiometabolic health in YwCP compared to wait list control (WC). A secondary aim is to describe feasibility metrics, namely, recruitment, retention, and adherence rates, perceived enjoyment, intervention safety, and management issues. The tertiary aim is to generate a theory that reveals critical behavioral mechanisms of adherence to tele-exergaming.
Methods:
In this parallel group design randomized controlled trial, 34 inactive YwCP are randomly allocated to one of two groups: a group that immediately receives 12 weeks of VR exergaming with tele-PE (VRT) or a WC group that undergoes their habitual activity for 12 weeks. Participants are recruited from a Children’s Hospital and community network. At baseline (week 0), week 6, and week 12, high sensitivity C-reactive protein and blood insulin, hemoglobin A1c, triglycerides, cholesterol, and pressure are measured by the youth and a caregiver at home using a blood spot test kit and blood pressure cuff. They will also self-measure their lung function and body weight, using a peak flow meter and bathroom scale, respectively. Collections are supervised by research staff via videoconference. Changes in outcomes are compared between and within groups using exploratory statistical analyses and descriptive statistics. At post-intervention or dropout, participants will undergo semi-structured interviews, to identify behavioral mechanisms that underly participation.
Results:
Recruitment procedures started in June 2022. All data are expected to be collected by October 2023. Full trial results are expected to be published by February 2024. Secondary analyses of data will be subsequently published.
Conclusions:
This trial tests an innovative serious exergaming virtual reality program that includes a completely remote enrollment, assessment, and intervention tele-protocol. The knowledge obtained will inform the development of a larger effectiveness trial for improving the health and well-being of YwCP. Clinical Trial: NCT05336227
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