Effect of a Virtual Reality-enhanced Exercise and Education Intervention on Patient Engagement and Learning in Cardiac Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Comparison of Participant 6-minute Walk Test Improvement Between Control and Intervention Groups
研究概览
简要总结
This study incorporates a virtual reality (VR) simulated walking environment, with audio component of patient education, into the treadmill portion of outpatient cardiac rehabilitation (CR). The VR program was developed by Plas.MD and is named Bionautica Trails.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Consent and enrollment process does not mention virtual reality to maintain blinding between control and intervention arms.
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
- •Participants must independently choose or be referred to Jefferson Health Methodist Cardiac Rehabilitation Program for outpatient cardiac rehabilitation.
- •Participants must have a referring cardiac condition requiring cardiac rehabilitation therapy.
排除标准
- •Physical inability to use treadmill
- •Medically unsafe to use a treadmill for 15 minutes
- •Inability to understand English
- •Unable to provide consent
研究组 & 干预措施
Standard of care
Participants receive normal cardiac rehabilitation according to approved standard of care. They use multiple pieces of exercise equipment at each session for increasing amounts of time and at incrementally increasing levels of difficulty. After establishing a baseline, participants are allowed to use the treadmill for "up to 15 minutes" at each session.
干预措施: Standard of care (Other)
Virtual walking trails
Participants use multiple pieces of exercise equipment at each session for increasing amounts of time and at incrementally increasing levels of difficulty. After establishing a baseline, participants are allowed to use the treadmill for "up to 15 minutes" at each session. The treadmill is positioned in front of a vertically oriented high definition television screen showing Bionautica Trails, virtual walking trails created by Plas.md.
干预措施: Virtual walking trails (Other)
结局指标
主要结局
Comparison of Participant 6-minute Walk Test Improvement Between Control and Intervention Groups
时间窗: From date of enrollment through study completion, an average of 12 weeks
Each participant will complete a 6MWT at both their first and last cardiac rehab treatment sessions. Distance improvement between first and last treatment session is expected for all participants. Average distance improvement (measured in feet) between study arms will be compared to evaluate effectiveness of interventions.
次要结局
- Participant Satisfaction with Cardiac Rehab Treatment(At completion of cardiac rehab treatment, an average of 12 weeks)
- Participant Cardiac Education Retention(At enrollment; at date of treatment completion, average of 12 weeks; two months following treatment completion)