High-intensity Interval Training Versus Moderate Continuous Training in Heart Transplant Recipients With Impaired Chronotropic Response: A Randomized Controlled Crossover Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- VO2peak
研究概览
简要总结
The aim of this study was to examine the effects of high intensity aerobic interval training (AIT) versus moderate continuous training (CON) in heart transplant recipients.
详细描述
Clinically stable heart transplant recipients > 12 month or more after HTx, age > 18 years, willing and capable of giving written informed consent for study participation and anticipated to be able to participate in the study for 12 months were included from the Heart Centre, Rigshospitalet, Copenhagen University Hospital.
Patients were excluded due to unstable condition or postoperative complications, recent severe rejection episodes (>H1R < 3 month), physical disabilities which prevent participation and re-transplantation or multi-organtransplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stable Heart transplant recipients > 12 month or more after HTx, age > 18 years,<
- •willing and capable of giving written informed consent for study participation.
排除标准
- •unstable condition postoperative complications, recent severe rejection episodes (>H1R < 3 month), re-transplantation or multi-organtransplantation.
结局指标
主要结局
VO2peak
时间窗: baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month).
baseline test before randomization 1. follow-up after 12 weeks of exercise 2. follow-up after 5 month washout. 3. follow-up after second 12 weeks period of exercise.
次要结局
- Endothelial function (endoPAT)(baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month).)
- Quality of Life (QoL)SF-36(baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month).)
- Bloodsamples/biomarkers.(baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month).)
- HADS-a, HADS-d anxiety and depression(baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month).)
- augmentation index (AI), endoPAT(baseline test (inclusion), follow-up 1(3 month), follow-up 2 (8 month), follow-up 3 (11 month).)
研究者
Christian Dall
Associate professor
Bispebjerg Hospital