Interest of Adding Neuromuscular Electrical Stimulation for Quadriceps Femoris and Triceps Surae Muscles to Pulmonary Rehabilitation in COPD : Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 266
- 试验地点
- 2
- 主要终点
- Walking distance change
研究概览
简要总结
Patients with COPD frequently have muscle disorders. Pathogenic mechanisms generate significant pathophysiological changes in the locomotor muscles structure, leading to decreased strength, decreased endurance and limited exercise capacity.
Pulmonary rehabilitation is the first choice therapy and training overall lower limb endurance is a priority. Even if the effects of pulmonary rehabilitation are no longer to be demonstrated, it is still necessary to optimize the modalities of muscular strengthening. In fact, it is recommended to associate to this global endurance training a specific strengthening of the muscles of the lower limbs. Neuromuscular electrostimulation (NMES) is a muscular strengthening technique, but this method is not used in usual practice in pulmonary rehabilitation and often only the quadriceps are concerned. In a pulmonary rehabilitation program, including sessions of NMES of the quadriceps femoris and triceps surae could increase its effectiveness.
Recent studies suggest that NMES can improve muscle function, exercise tolerance, dyspnea and quality of life in COPD patients.
A pilot study compared the effects of the combined quadriceps femoris and triceps surae versus quadriceps alone. The final evaluation showed a greater improvement in exercise capacity in favour of the combined NMES group. Only two studies with small numbers of patients evaluated the effect of combined quadriceps femoris and triceps surae NMES in pulmonary rehabilitation, with encouraging results in terms of functional gain. Further larger studies seem necessary to evaluate the effects of combined quadriceps femoris and triceps surae NMES in pulmonary rehabilitation. The objective of the study is to show that combined quadriceps femoris and triceps surae NMES during a pulmonary rehabilitation program provides a more significant improvement in exercise capacity compared to a standard pulmonary rehabilitation program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
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
- •Patient with COPD stages 2 to 4 (A to D) admitted to the Pulmonary Rehabilitation Department of the "Centre Hospitalier des Pays de Morlaix" or the "CHRU of Brest".
- •Patient aged 18 years or older.
- •Patient able to consent and having signed a consent form.
排除标准
- •Patient with a history of pneumonectomy, lobectomy dated less than 6 months old
- •Patient with an inability to complete a respiratory rehabilitation program in its entirety
- •Patient under guardianship or curatorship
- •Person equipped with electronic devices such as pacemakers and intracardiac defibrillators.
- •Skin lesions and infectious foci on the area where the electrodes.
- •Pregnant or breastfeeding women
结局指标
主要结局
Walking distance change
时间窗: Day 0 and Day 28
Assessment of the walking distance (in meters) covered during the 6-minute walking test before and after rehabilitation (between D0 and D28± 4 days). The main endpoint is the change (in meters) between Day 0 and Day 28.
次要结局
- Maximal isometric voluntary triceps surae strengh change(Day 0 and Day 28)
- Isotime dyspnea change with the endurance shuttle walk test(Day 28)
- Dyspnea change with the mMRC (modified Medical Research Council) scale(Day 0 and Day 28)
- Maximal isometric voluntary quadriceps strengh(Day 0 and Day 28)
- Dyspnea change with the LCADL (London Chest Activity of Daily Living) questionnaire(Day 0 and Day 28)
- Exercise capacity change with the 1 min sit to stand test(Day 0 and Day 28)
- Quality of life change with the St George's Respiratory Questionnaire(Day 0 and Day 28)
- Fear of fall change with the FES (Falls Efficacy Scale) questionnaire(Day 0 and Day 28)
- Maximal isometric voluntary endurance change(Day 0 and Day 28)
- Exercise capacity change with the 6 min step test(Day 0 and Day 28)
- Exercise capacity change with the incremental shuttle test(Day 0 and Day 28)
- Exercise capacity change with the endurance shuttle walk test(Day 0 and Day 28)
- Dyspnea change with the Dyspnea-12 questionnaire(Day 0 and Day 28)
- Quality of life change with the CAT (COPD Assessment Test) Questionnaire(Day 0 and Day 28)
- Non fat mass index change(Day 0 and Day 28)
- Depressive disorder change(Day 0 and Day 28)
- Anxiety disorder change(Day 0 and Day 28)
- Self esteem change(Day 0 and Day 28)
- Dyspnea change during the 6-minute walking test(Day 0 and Day 28)