Quadricipital Electrical Stimulation in COPD Patients Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- 6 minute walking distance
研究概览
简要总结
Quadricipital electrical stimulation added to respiratory rehabilitation in COPD patients.
Quadricipital electrical stimulation (ES) in chronic obstructive pulmonary disease (COPD) patients has been demonstrated to improve both dyspnea and physical status. The aim of our study is to demonstrate that ES added to respiratory rehabilitation program induces a greater improvement on exercise tolerance in such patients.
Design : 160 patients with severe COPD will be randomly assigned to 2 groups : either rehabilitation program (group 1), either ES and rehabilitation program (group 2). In both groups, rehabilitation program comprises endurance training, 18 - 24 sessions (6 - 8 weeks), health education, global muscular strengthening. In group 2, bilateral quadricipital electrical stimulation 30 min sessions is added 5 days / week.
Subjects : COPD patients with FEV1 < 60% pred, FEV1/VC < 70%, and TLC > 80%, with dyspnea, in stable conditions, and 18 > BMI < 35 kg/m² .
Intervention : 6 min walking distance, incremental exercise test data (aerobic capacity, work rate, ventilatory threshold), physical activity with activity monitor, health related quality of life will be determined before and after training.
Abbreviations : FEV1 = forced expiratory volume in 1 sec; VC = vital capacity; TLC = total lung capacity; BMI = body mass index.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects : COPD patients with FEV1 < 60% pred, FEV1/VC < 70%, and TLC > 80%, with dyspnea, in stable conditions, and 18 > BMI < 35 kg/m²
排除标准
- •BMI 18 < or > 35 kg/m²
- •Pregnant women
- •peripheral neuropathy
- •cardio respiratory incremental test contra-indication
- •evolutive cancer
- •cardiac or cerebral pace maker, implanted cardio defibrillator
- •no informed consent given
研究组 & 干预措施
Group 2 : quadricipital electrical stimulation
stimulation in addition to rehabilitation (30 min bilateral quadricipital electrical stimulation pd, 5 days per week, 8 weeks)
干预措施: group 2 : quadricipital electrical stimulation (Device)
Group 2 : quadricipital electrical stimulation
stimulation in addition to rehabilitation (30 min bilateral quadricipital electrical stimulation pd, 5 days per week, 8 weeks)
干预措施: muscular electrical stimulation (Device)
Group 1 : Pulmonary rehabilitation
Pulmonary rehabilitation 3 to 5 times per week, 8 weeks
干预措施: pulmonary rehabilitation (Other)
结局指标
主要结局
6 minute walking distance
时间窗: From 6 to 8 weeks
次要结局
- incremental cardio pulmonary exercise test(From 6 to 8 weeks)