Prevention of Post-exercise Muscle Fatigue Using a Non Invasive Ventilation and Effect on Exercise Training in Severe Patients With COPD. QUADRIVEND Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 3
- 主要终点
- Strength of the correlation between the change of TlimQ (min) and the training load calculated as intensity (in watts) x duration of the session (minute) x number of sessions
研究概览
简要总结
In patients with severe Chronic Obstructive Pulmonary Disease (COPD), exercise tolerance is severely impaired due to a ventilatory limitation, levelling off the intensity of exercise. This reduces the physiological benefit of pulmonary rehabilitation. In these patients, it is then proposed to add an Inspiratory Pressure Support (IPS) in order to increase the intensity and the duration of every training session. In a preliminary study, the investigators showed that IPS applied during an exhaustive cycling exercise allowed to prevent the onset of post-exercise quadriceps fatigue evaluated by the endurance time to isotonic quadriceps contractions (TlimQ).
The aim of this study is to determine the relationship between the prevention of post-exercise fatigue (TlimQ) and the change in training load (intensity x time x number of sessions) during a pulmonary rehabilitation programme. At the beginning of the training programme, 25 patients will be evaluated for TlimQ after a cycling exercise (70% maximal workload) with and without IPS in random order. The training load was then monitored at every exercise session of the programme.
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
- Single (Participant)
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
- •Severe COPD patients in stable condition (Gold class 3 or 4)
- •Ventilatory limitation to exercise during the incremental cardiopulmonary exercise test (at least one of the following criteria) :
- •No breathing reserve
- •Exercise hypoventilation (increase arterial PCO2> 5 mmHg)
- •Maximal workload <50 Watts
排除标准
- •IPS not tolerated during a preliminary cycling exercise test
- •Enable to perform the exercise tests or the rehabilitation programme
- •Decline to participate
研究组 & 干预措施
Inspiratory help then sham ventilation
The initial evaluation is performed using an Inspiratory Pressure Support. After the training, the final evaluation is performed using an Inspiratory help (sham ventilation).
干预措施: Inspiratory help then sham ventilation (Device)
Sham ventilation then Inspiratory help
The initial evaluation is performed using an inspiratory help (sham ventilation).
After the training, the final evaluation is performed using an Inspiratory Pressure Support.
干预措施: Sham ventilation then Inspiratory help (Device)
结局指标
主要结局
Strength of the correlation between the change of TlimQ (min) and the training load calculated as intensity (in watts) x duration of the session (minute) x number of sessions
时间窗: Visit 24 (week 8)
At the beginning of the programme, we evaluate the influence of IPS on TlimQ (visits 2 and 3). After the training period, we repeated the same evaluations (visits 23 and 24). Then, we will compare this difference before and after the training period, and we will seek for a relation with the training load.
次要结局
- variation of TlimQ after a cycling exercice untill fatigue without IPS at the beginning and the end of pulmonary rehabilitation evaluated by the endurance time to isotonic quadriceps contractions(Visit 24 (week 8))
- relationship between the change in the endurance to cycling exercise without and with IPS and the change in TlimQ(Visit 24 (week 8))
- variation TlimQ of post-exercise without and with IPS(Visit 3 (week 1))
- relationship between the change in the endurance to cycling exercise with IPS and the change in TlimQ(Visit 24 (week 8))
- variation of TlimQ after a cycling exercice untill fatigue with IPS at the beginning and the end of pulmonary rehabilitation evaluated by the endurance time to isotonic quadriceps contractions(Visit 24 (week 8))