NCT00752336Unknown不适用
Prospective Intervention Study to Improve HRQoL and Exercise Tolerance After Heart Transplantation
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 87
- 主要终点
- HRQoL,exercise capacity
研究概览
简要总结
A prospective, interventional rehabilitation program was initiated to improve exercise tolerance and psychosocial functioning in patients after heart transplantation (HTx) and to evaluate long-term effects on health-related quality of life (HRQoL).Study subjects were randomized to either intervention or to control group and were followed with regular cardiopulmonary exercise testings and HRQoL measurements (SF-36) for 36±3 months after HTx. Patient characteristics did not differ concerning age, gender, and diagnosis at study entry. IG patients received regular psychosocial support and performed a home-based supervised ergometer training program. CG patients were recommended to perform regular exercising.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Heart transplant (6-9 mts post Tx) stabile health condition at study entry (pt stays within home environment)
- •Age ≥ 18 yrs
- •Sufficient language skills to answer questionnaire
- •Follow-up at our center
- •Willingness to participate by written informed consent
排除标准
- •TVP diagnosis before study inclusion
- •Episodes of recurrent acute rejections
- •Medical contra-indication for regular exercise ergometer training
- •Malignancy
结局指标
主要结局
HRQoL,exercise capacity
时间窗: 36 mts
次要结局
- Weight gain; cardiovascular risk factors; social re-integration(36 mts)
研究者
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