Telehealth Virtual Reality Exergaming and Peer Networking Among People With Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Total play time
研究概览
简要总结
This pilot feasibility study aims to test whether youth and adults with spinal cord injury can use a group virtual reality gaming intervention to exercise. A second purpose is to examine whether there are potential benefits to cardiometabolic health and psychosocial health.
详细描述
There are three purposes to this study.
The first purpose is to quantify feasibility through telemonitored exercise data: total play time, moderate exercise time, playtime with others, and compliance to the data collections. These variables will be compared against a priori criteria for acceptability. These variables will help determine whether modifications to the intervention protocol are necessary.
The second purpose is to qualitatively interview participants to explain underlying behavioral mechanisms that affect their participation in the program. This information will be used to explain how to improve implementation issues identified in Aim 1.
The third aim is to explore the potential effects of the program on self-reported psychosocial health and quality of life, hand-grip strength, and cardiometabolic health (blood cholesterol, lipids, pressure, and insulin) measured via home dried blood spot test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •medical diagnosis of traumatic spinal cord injury (determined by International Classification of Disease [ICD] codes)
- •a caregiver to support the participant if the participant is a child (<18 years of age)
- •access to a Wi-Fi Internet connection in the home
排除标准
- •physically active (defined as >150 minutes per week of moderate-to-vigorous intensity exercise in a typical week)
- •cannot use the arms for exercise or operate the controller buttons using their fingers
- •complete blindness or deafness
- •recent myocardial infarction or electrocardiography changes, complete heart block, acute congestive heart failure, unstable angina, and uncontrolled severe hypertension [BP >/= 180/110 mmHg]
- •prone to seizures
结局指标
主要结局
Total play time
时间窗: Intervention Week 1 - Week 8
Percentage of the 300 minutes of prescribed play per week across the intervention.
Total exercise time
时间窗: Intervention Week 1 - Week 8
Moderate exercise minutes where prescription was met (percent of prescription achieved: weeks where the ≥90 minutes of moderate intensity exercise per week was achieved across the intervention, divided by total weeks).
Compliance to post data collections
时间窗: Week 9
Number of pre data collections completed, converted into a percentage dividing by the total possible.
Compliance to baseline data collection
时间窗: Week 0
Number of pre data collections completed, converted into a percentage dividing by the total possible.
Playtime with others
时间窗: Intervention Week 1 - Week 8
Measured by the number of play sessions with other players (online multiplayer and/or peer-gaming). This number will be totaled across the 8-week intervention and divided by 16 (the exercise prescription of 2 x per week of multiplayer gaming).
次要结局
- Changes in blood pressure(Week 0, Week 5, Week 9)
- Changes in high sensitivity C-reactive protein (hsCRP)(Week 0, Week 5, Week 9)
- Changes in low-density lipoprotein (LDL)(Week 0, Week 5, Week 9)
- Changes in hemoglobin A1c(Week 0, Week 5, Week 9)
- Functional Grip Strength(Week 0, Week 5, Week 9)
- Changes in fasting insulin(Week 0, Week 5, Week 9)
- Changes in total cholesterol(Week 0, Week 5, Week 9)
- Critical factors that affected adherence(Intervention Week 9)
- Hospital Anxiety and Depression Scale(Week 0, Week 5, Week 9)
- World Health Organization Quality of Life(Week 0, Week 5, Week 9)
- Changes in fasting triglycerides(Week 0, Week 5, Week 9)
- Changes in high-density lipoprotein (LDL)(Week 0, Week 5, Week 9)
研究者
Byron Lai
Assistant Professor
University of Alabama at Birmingham