虚拟现实远程运动游戏对脑瘫青少年心脏代谢健康指标的影响：一项试点随机对照试验方案

The Effects of Virtual Reality Tele-exergaming on Cardiometabolic Indicators of Health Among Youth With Cerebral Palsy: Protocol for a Pilot Randomized Controlled Trial.

作者信息

Lai Byron, Davis Drew, Young Raven, Kimani-Swanson Erin, Wozow Cynthia, Wen Huacong, Kim Yumi, Wilroy Jereme, Rimmer James

机构信息

Division of Pediatric Rehabilitation Medicine, Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL, United States.

Department of Physical Medicine & Rehabilitation, University of Alabama at Birmingham, Birmingham, AL, United States.

出版信息

JMIR Res Protoc. 2022 Aug 17;11(8):e40708. doi: 10.2196/40708.

DOI:10.2196/40708

PMID:35976192

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9434386/

Abstract

BACKGROUND

Youth with cerebral palsy 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 a 12-week home-based virtual reality tele-exergaming intervention on several indicators of cardiometabolic health in youth with cerebral palsy compared to the wait list control. 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 youths with cerebral palsy are randomly allocated to one of two groups: a group that immediately receives 12 weeks of virtual reality exergaming with tele-physical education or a wait list control 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 A, 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 postintervention or dropout, participants will undergo semistructured 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 youth with cerebral palsy.

TRIAL REGISTRATION

ClinicalTrials.gov NCT05336227; https://clinicaltrials.gov/ct2/show/NCT05336227.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/40708.

摘要

背景

患有脑瘫的青少年没有令人愉悦、可及且可扩展的锻炼选择，无法使他们有能力独立维持心脏代谢健康。

目的

主要目的是研究一项为期12周的基于家庭的虚拟现实远程运动游戏干预对脑瘫青少年心脏代谢健康的几个指标的初步疗效，并与等待名单对照组进行比较。次要目的是描述可行性指标，即招募率、留存率和依从率；感知到的乐趣；干预安全性；以及管理问题。第三个目的是生成一种理论，揭示坚持远程运动游戏的关键行为机制。

方法

在这项平行组设计的随机对照试验中，34名不活动的脑瘫青少年被随机分配到两组中的一组：一组立即接受为期12周的虚拟现实运动游戏和远程体育教育，另一组是等待名单对照组，他们进行12周的日常活动。参与者从一家儿童医院和社区网络招募。在基线（第0周）、第6周和第12周，青少年和一名照顾者在家中使用血斑检测试剂盒和血压袖带测量高敏C反应蛋白、血液胰岛素、糖化血红蛋白、甘油三酯、胆固醇和血压。他们还将分别使用峰值流量计和体重秤自行测量肺功能和体重。采集过程由研究人员通过视频会议进行监督。使用探索性统计分析和描述性统计比较组间和组内结果的变化。在干预后或退出时，参与者将接受半结构化访谈，以确定参与背后的行为机制。