Virtual-reality-guided Exercise and Mindfulness Program for People with Chronic Pain Under Rehabilitation: a Randomised Controlled Cross-over Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 4
- 主要终点
- Heart rate
研究概览
简要总结
In this study we assessed the feasibility of a VR-guided intervention seeking to improve physical fitness in individuals with chronic pain. In a randomised controlled trial with a cross-over design and participants in rehabilitation for chronic pain were asked to perform, in a counter-balanced order, five minutes of aerobic exercise following identical instructions given through either a VR headset or TV screen. The procedures were then repeated with mindfulness exercises. Heart rate (HR) was monitored throughout all four sessions and participants self-reported perceived exercise intensity, benefit, relaxation, and reward. Paired Student's t-test, Wilcoxon signed rank test and McNemar's test were performed to compare the outcome variables across sessions for individuals, as appropriate.
详细描述
Participants: were recruited through partner patients' organizations, a local exercise group aimed at people living with rheumatological conditions, and an inpatient occupations rehabilitation centre.
The study was conducted according to the Helsinki declaration and approved by the Local committee for medical and health research ethics at the Inland Norway University of Applied Sciences (Ref. 20616405).
Study design The study was designed as a randomised controlled trial with a cross-over design.
Intervntion: Each participant underwent five exercise sessions in total. Firstly, all participants performed a six- minutes warm-up session following instructions projected on a TV screen. Subsequently, the participants performed two aerobic exercise sessions, identical in content and duration (five- minutes), once following the instructions from VR (VR-A) and once following the identical program that was displayed on a TV screen (TV-A). The allocation of the first aerobic exercise session as VR-A or TV-A was randomly assigned for each individual. After completing the first aerobic exercise session, the participants were subsequently asked to complete the second session guided through the opposite mode of delivery. After the exercise sessions the same randomised cross-over design was followed for two five- minute mindfulness sessions, with the participants undergoing, in a counter-balanced and random order, a guided mindfulness program, once delivered through VR (VR-M) and once displayed on a TV screen (TV-M).
Virtual environment and technology In the VR-A and VR-M, the participants wore a stand-alone HMD (Oculus Quest 2 with stock headstrap, Meta Platforms, Menlo Park, California, USA). The virtual environment was developed by Fynd Reality AS (Hamar, Norway), in line with general criteria outlined during the participatory process and consisted of a computer-generated replication of Hamar's town square (Norway). Each participant would enter this town square as a virtual avatar with virtual arms and body. The position of the arms was tracked by the hand-held controllers. A large screen would appear in the virtual town square, showing a video in which an instructor guided the exercises for the various sessions. This was the same video as shown on the TV screen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
盲法说明
No masking was possible
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria were adults (>18 years of age) with chronic musculo-skeletal pain.
排除标准
- •The exclusion criteria were inability to perform VR-delivered physical exercise
结局指标
主要结局
Heart rate
时间窗: For duration of interventions, an average of 30 minutes.
HR was registered throughout the sessions using a HR-monitors worn at the wrist (Garmin® Forerunner 55). The mean HRs for the last three minutes of each session were calculated for each individual. For the aerobic exercise sessions, HR was also categorised into HR-zones according to the ACSM recommendations based on the participants' predicted maximal HR (220 minus age) 4, with the proportion of time spent in " moderate-vigorous exercise intensity" (i.e., HR \> 65% of maximum heart rate) being calculated and used for further analysis.
次要结局
- Exercise intensity(After 10 minutes)
- Perceived degree of relaxation(After 10 minutes)
- Perceived reward(After 10 minutes)
- Exercise adherence(After 10 minutes)