NCT02156245已完成不适用
Evaluation of the Effects of Eccentric Training on a Cycle Ergometer, Versus Conventional Concentric Training
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 212
- 试验地点
- 4
- 主要终点
- For COPD patients : Endurance time at 75 % of peak workload achieved on a cycle ergometer during the initial concentric cardiopulmonary exercise test (CPET)
研究概览
简要总结
The aim of this study is to assess the efficacy of a rehabilitation protocol based on individualized combined eccentric and concentric cycle ergometer training compared to classical concentric cycle training among patients with either coronary artery disease (CAD) or chronic obstructive pulmonary disease (COPD). This study will therefore evaluate the efficacy of combined eccentric/concentric training on physical capacity and overall autonomy, and will analyse the adaptive mechanisms with regard to both adaptation to cardiac and muscular effort and tolerance.
详细描述
The research will take place in 3 phases:
PHASE 1 :
30 healthy volunteers will be included to test tolerance to personalized exercise on an eccentric cycle ergometer.
PHASE 2 :
15 patients suffering from coronary artery disease (CAD) and 15 patients suffering from chronic obstructive pulmonary disease (COPD) will be included to test the same protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Persons who have provided written informed consent
- •Healthy volunteers:
- •Men or women aged between 40 and 75 years.
- •Patients with CAD:
- •Men or women aged between 40 and 75 years, with coronary artery disease without heart failure referred for a rehabilitation program.
- •Left ventricular ejection fraction on echocardiography (Simpson methode) > 45 %
- •Patients with Chronic obstructive pulmonary disease:
- •Men or women aged between 40 and 75 years
- •Severe Chronic obstructive pulmonary disease (post-bronchodilatator FEV1/FVC < 0.70 and FEV1 ≤ 60% of predicted value)
- •Patient not on oxygen therapy (24h/24)
排除标准
- •Person without national health insurance cover
- •Severe, obstructive cardiopathy
- •Severe aortic valve stenosis,
- •Severe progressive heart rhythm or conduction disorders not corrected by a pacemaker and detected during the initial effort test
- •Cardiac intracavitary thrombus,
- •Severe pulmonary artery hypertension (PAHT systolic >70mmHg),
- •Recent history of venous thromboembolism (previous 3 months),
- •Impaired executive functions making it impossible to understand and adhere to a rehabilitation program (Mini Mental Test < 24),
- •Heart transplant,
- •Associated medical condition that could substantially affect functional capacities (examples: non-stabilized metabolic disorders such as progressive renal insufficiency, major asthenia linked to a severe non-stabilized disorder such as neoplasia, systemic disease...).
- •Physical incapacity of the lower limbs that could impair rehabilitation, whether they are neurological (central or peripheral), arterial (in particular, peripheral artery disease with a systolic index < 0.6) or orthopedic (degenerative or inflammatory rheumatism).
- •Patients who have taken part (within the previous 6 months) or a currently taking part in a rehabilitation program.
结局指标
主要结局
For COPD patients : Endurance time at 75 % of peak workload achieved on a cycle ergometer during the initial concentric cardiopulmonary exercise test (CPET)
时间窗: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
For patients with CAD: Distance covered during a 6-minute walk test and triceps surae maximal isometric force
时间窗: Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks
次要结局
- For CAD patients: Functional Independence Measure(Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks)
- For CAD patients: Step test with gas exchange measurement(Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks)
- For CAD patients: Distance covered in the 6-minute walk test(Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks)
- For CAD patients: peak VO2 and 1st ventilation adaptation threshold(Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks)
- For CAD patients: cardiac output measured non-invasively(Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks)
- For CAD patients: Measurement of lactates(Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks)
- For CAD patients: heart rate and systolic blood pressure(Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks)
- For CAD patients: maximum isometric muscle strength of the triceps and quadriceps(Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks)
- For CAD patients: Timed up and go test(Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks)
- For CAD patients: tissue oxygenation measured by infrared spectroscopy (non-invasive) at the quadriceps(Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks)
- For COPD patients: peak VO2 and 1st ventilation adaptation threshold(Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks)
- For COPD patients: SpO2 measurement and heart rate during the sessions (warm-up, end of session)(Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks)
- For COPD patients: Measurement of lactates(Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks)
- For COPD patients: muscle composition and vascularization through muscle biopsies (optional)(Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks)
- For CAD patients: VO2 measurement during the 6 minute walk test(Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks)
- For CAD patients: reaction hyperaemia in the circumflex humeral artery mesured by ultrasound(Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks)
- For COPD patients: Distance covered in the 6-minute walk test(Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks)
- For COPD patients: arterial compliance (pulse wave velocity measurement)(Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks)
- For COPD patients: BDI/TDI and mMRC dyspnea assessment(Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks)
- For COPD patients: St George's Respiratory Questionnaire (SGRQ)(Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks)
- For COPD patients: Quality of life-BPCO (VQ11)(Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks)
- For COPD patients: SpO2 and heart rate measurement before, during and after the 6-minute walk test(Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks)
- For COPD patients: maximum isometric muscle strength of the quadriceps(Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks)
- For COPD patients: COPD Assessment Test (CAT)(Between the initial evaluation (D0) and the final reconditioning evaluation, assessed up to 8 weeks)
研究者
研究点 (4)
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