Eccentric Cycling Exercise During Pulmonary Rehabilitation in Patients With Cardiopulmonary Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 3
- 主要终点
- Peak exercise performance [Watts]
研究概览
简要总结
Eccentric cycling exercise (ECC) allows training at low metabolic costs and may therefore be valuable for patients with pulmonary vascular disease (PVD). For these patients, regular exercise training has an evidence level 1A recommendation in the current guidelines. Exercise training during longer and regular periods provides chronic adaptation, for which ECC was recently found to have a greater effectiveness than CON by increasing muscle strength, hypertrophy, six-minute walking distance and furthermore, by increasing maximum oxygen uptake (V'O2max) especially in patients with chronic obstructive pulmonary disease (COPD), chronic left heart failure or coronary heart disease. Furthermore, we conducted an RCT in which we exposed patients with PVD to ECC and concluded that ECC is a feasible and well-tolerated exercise modality for PVD patients with severely lower O2 demand and load to the right ventricle. The study in patients with PVD was started (EccRehab), and the great potential was recognized. Therefore there was an indication to open the inclusion criteria to all cardiopulmonary patients with indication for pulmonary rehabilitation (EccRehab2).
For this purpose, the aim of this project is to investigate whether ECC improves exercise capacity and possibly hemodynamics during prolonged rehabilitation programs in patients with cardiopulmonary diseases.
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with PVD, either PAH or CTEPH via right heart catheterization, according to recent guidelines [9]
- •Diagnosed with a cardiopulmonary disease as indication for a pulmonary rehabilitation
- •Stable medication for at least 1 month
- •Age 18years to 85 years
- •No resting hypoxemia (PaO2 >7.3 kPa)
- •Medical indication to prescibe a pulmonary rehabilitation
排除标准
- •Any co-morbidity that limits the patient to participate the full rehabilitation
- •Enrollments in other trials with active treatments
- •Language barriers that limits the patient to participate in the rehabilitation
研究组 & 干预措施
Eccentric cycling
Patients perform eccentric cycling exercise instead of normal cycling exercise in addition to standard car during a cardiopulmonary rehabilitation
干预措施: Eccentric cycling exercise (Other)
Standard care
Patients perform cardiopulmonary rehabilitation according to standard care
干预措施: Standard Care Arm (Other)
结局指标
主要结局
Peak exercise performance [Watts]
时间窗: At baseline pre-intervention and immediately after three weeks of rehabilitation
Peak exercise performance is measured during cardiopulmonary exercise tests on a cycle ergometer. The Unit of the measurement is watts.
次要结局
- Peak oxygen uptake [L/min](At baseline pre-intervention and immediately after three weeks of rehabilitation)
- Ventilatory equivalents for carbon dioxide (Minute ventilation / carbon dioxide output)(At baseline pre-intervention and immediately after three weeks of rehabilitation)
- Six minute walk distance [meters](At baseline pre-intervention and immediately after three weeks of rehabilitation)
- Knee extension test [repetitions](At baseline pre-intervention and immediately after three weeks of rehabilitation)
- Systolic pulmonary arterial pressure [mmHg](At baseline pre-intervention and immediately after three weeks of rehabilitation)
- Total pulmonary reistance [Wood units](At baseline pre-intervention and immediately after three weeks of rehabilitation)
- Right ventricular to arterial coupling [mm/mmHg](At baseline pre-intervention and immediately after three weeks of rehabilitation)
- Cardiac output [L/min](At baseline pre-intervention and immediately after three weeks of rehabilitation)
- Arterial partial pressure for oxygen [kPa](At baseline pre-intervention and immediately after three weeks of rehabilitation)
- Arterial partial pressure for carbon dioxide [kPa](At baseline pre-intervention and immediately after three weeks of rehabilitation)
- Arterial oxygen saturation [%](At baseline pre-intervention and immediately after three weeks of rehabilitation)
- Patient reported leg fatigue [scale from 1 to 10](At baseline pre-intervention and immediately after three weeks of rehabilitation)
- Patient reported dyspnea [scale from 1 to 10](At baseline pre-intervention and immediately after three weeks of rehabilitation)
- Patient reported quality of life [cm](At baseline pre-intervention and immediately after three weeks of rehabilitation)
研究者
Silvia Ulrich Somaini
Prof. Silvia Ulrich
University of Zurich