Strong Hearts: A Remote, App-Enabled, Exercise Program for Patients With Congenital Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Change in peak rate of oxygen volume consumption (VO2) on Cardiopulmonary Exercise Testing
研究概览
简要总结
The overall goal of this program is to create a remote, mobile application enabled exercise program for patients with Congenital Heart Disease (CHD). Pilot trials will consist of a remote exercise program with app-embedded exercise modules designed to promote and encourage safe and healthy exercise habits across a range of CHD anatomies. This app-enabled program will allow for real time data collection integrating wearable devices, as well as compliance and safety monitoring to enhance research capabilities. The app-enabled program will be versatile and may be applied in the future to patients with non-cardiac conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Repaired or unrepaired Congenital Heart Disease (CHD)
- •Between ages 10 and 50, inclusive, at time of consent
- •Android or Apple smartphone that meets the operating systems below with the ability to download applications from either Google Play or the Apple store
- •Android: 6.0 or higher
- •Apple: iPhone Operating System (iOS) 13 or higher
排除标准
- •Physical or mental disabilities preventing exercise participation
- •Uncontrolled systemic hypertension (symptomatic or greater than Stage 2 hypertension while on therapy)
- •Poorly controlled arrhythmia
- •Clinically unstable heart failure
- •Known pregnancy at the time of enrollment
研究组 & 干预措施
Exercise Group
Participants will participate in a remote, app-enabled exercise program consisting of strength and aerobic exercises for four to twelve weeks. They will perform the exercises 3-5 times a week at home guided by exercise videos in the app. The exercise sessions will increase in frequency throughout the training regimen. The videos will include athletes demonstrating how to perform each exercise safely, and provide tips for optimal form and breathing. Participants will wear wearable fitness trackers and monitor their heart rates during exercise sessions.
干预措施: Strong Hearts Exercise Program (Behavioral)
结局指标
主要结局
Change in peak rate of oxygen volume consumption (VO2) on Cardiopulmonary Exercise Testing
时间窗: Baseline, up to 12 weeks
次要结局
- Change in Pediatric Cardiac Quality of Life Inventory(1 year)
- Change in sit-to-stand test(Baseline, up to 12 weeks)
- Change in Short Form 36 (SF-36) Health Survey(1 year)
- Change in secondary Cardiopulmonary Exercise Testing outcome measures(Baseline, up to 12 weeks)