Cardiopulmonary Rehabilitation for Adolescents and Adults With Congenital Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Change in aerobic exercise capacity (peak VO2)
研究概览
简要总结
The hypothesis of this study is that participation in a formal cardiopulmonary rehabilitation program improves aerobic exercise capacity and quality of life over the medium term for patients with congenital heart disease with reduced exercise capacity. To test this hypothesis, subjects will be randomized to either receive a 12-week cardiopulmonary rehabilitation program or standard of care, with interval testing of aerobic capacity and other physiologic markers improved fitness, as well as assessment of quality of life.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to participate in a 12-week cardiac rehabilitation program and repeated cardiopulmonary exercise testing
- •pVO2≤80% predicted (impaired aerobic capacity) on baseline exercise test
- •congenital heart disease of at least moderate complexity
排除标准
- •Cardiac intervention (cath/surg) within prior 6m
- •Planned cardiac intervention (cath/surg) within 12m
- •Formal cardiac rehabilitation within 24m
- •Current/recent (delivery<90d prior) pregnancy, planned pregnancy within 12m
- •Active heart failure, hospitalization or major change in clinical status over prior 30d
- •Other recent or planned events expected to have a significant impact on exercise capacity
- •Baseline oxygen saturation <92%
研究组 & 干预措施
Cardiopulmonary rehabilitation
The subjects will attend 2 sessions each week for 12 weeks. Each session will be approximately 2 hours in duration, consisting of both exercise (aerobic and strength,~60 minutes) and education. In addition, subjects will be directed to participate in 3 weekly ~40 minute home exercise training sessions, personalized to their level of aerobic conditioning.
干预措施: Cardiopulmonary rehabilitation (Other)
Standard of care
Subjects randomized to standard of care will not be enrolled in a rehabilitation program, but may receive any other clinically indicated exercise training or other intervention (e.g., an exercise prescription).
干预措施: Standard of care (Other)
结局指标
主要结局
Change in aerobic exercise capacity (peak VO2)
时间窗: Baseline to 3 months (primary)
次要结局
- Change in quality of life measurement(Baseline to 3 months (primary))
研究者
Alexander Opotowsky
Assistant Professor
Boston Children's Hospital