Effect of Neuromuscular Electrical Stimulation Versus Cycle Ergometer Training in a Pulmonary Rehabilitation Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 4
- 主要终点
- functional capacity of the lower limb muscles
研究概览
简要总结
The aim of this study is to evaluate the effectiveness of quadriceps strengthening with neuromuscular electrical stimulation versus cycle ergometer as part of pulmonary rehabilitation program , in patients with severe or very severe COPD , according to GOLD with BODE index ≥ 5 .
详细描述
It's a prospective ,multicentre,randomised, single-blind study which compare the effectiveness of quadriceps strengthening with neuromuscular electrical stimulation versus cycle ergometer training as part of pulmonary rehabilitation program.
The program lasts from 3 to 4 weeks. 102 patients will included, diagnosed with COPD stages GOLD III and IV, and BODE index ≥ 5.
The commun program: training protocol performed on treadmill,quadriceps resistance training,patient therapeutic education,collective gymnastics,relaxation, session psychological care, smoking cessation program and nutritional management if necessary.
The primary criterion is the one minute sit to stand test.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with COPD stage 3 or 4, with BODE index ≥ 5
- •Hospitalized in the pulmonary rehabilitation unit in the hospital of Morlaix or in the center "Les Acacias" of briançon, with a 3 at 4 weeks pulmonary rehabilitation course;
排除标准
- •FEV ≥ 50%
- •Pneumonectomy, Lobectomy less than 6 months
- •Contraindications to muscle electrostimulation quadriceps
- •Absence of written consent
- •Inability to follow the respiratory rehabilitation program in its entirety
- •People equipped with electronic devices such as pacemakers and intracardiac defibrillators
- •Skin lesions and infectious foci on the electrode placement area.
研究组 & 干预措施
neuromuscular electrical stimulation
conventional pulmonary rehabilitation including exercise training on treadmill and neuromuscular electrical stimulation with a medical device for quadriceps muscle strengthening
干预措施: neuromuscular electrical stimulation (Device)
neuromuscular electrical stimulation
conventional pulmonary rehabilitation including exercise training on treadmill and neuromuscular electrical stimulation with a medical device for quadriceps muscle strengthening
干预措施: Conventional pulmonary rehabilitation (Other)
cycle ergometer training
conventional pulmonary rehabilitation including exercise training on treadmill and quadriceps strenghthening on cycle-ergometer
干预措施: cycle ergometer training (Device)
cycle ergometer training
conventional pulmonary rehabilitation including exercise training on treadmill and quadriceps strenghthening on cycle-ergometer
干预措施: Conventional pulmonary rehabilitation (Other)
结局指标
主要结局
functional capacity of the lower limb muscles
时间窗: 21 - 4 days / +7 days
Measure of the functional capacity of the lower limb muscles with the "1 minute Sit To Stand Test "
次要结局
- Maximal isometric voluntary quadriceps strength assessment(21 - 4 days / +7 days)
- isometric voluntary quadriceps endurance assessment(21 - 4 days / +7 days)
- Dyspnea Assessment with MRC Scale(21 - 4 days / +7 days)
- assessment of exercise capacity(21 - 4 days / +7 days)
- Quality of Life Assessment(21 - 4 days / +7 days)
- Dyspnea Assessment with Borg scale(21 - 4 days / +7 days)
- Dyspnea Assessment with Dyspnea 12 questionnary(21 - 4 days / +7 days)
- Inspiratory capacity (in litres) by spirometry(21 - 4 days / +7 days)