Combination of Pulmonary Rehabilitation and Neuromuscular Electrical Stimulation and in COPD Patients: a Randomized Clinical Trial of Efficacy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- Exercise Capacity
研究概览
简要总结
The purpose of this study is to elucidate whether combination of usual pulmonary rehabilitation and neuromuscular electrical stimulation of quadriceps may improve exercise capacity in patients affected by chronic obstructive pulmonary disease (COPD).
详细描述
Neuromuscular electrical stimulation (NMES) has been extensively used as technique to improve muscle function in different areas of rehabilitation, however it seems to be more appropriate in critical care situation, while its use in more able patients is of uncertain benefit. In other words, NMES seems to be particularly effective in severely deconditioned and bed ridden patients. We therefore carried out a randomised trial to compare the efficacy of combination of NMES and PR (NM+PR) with combination of sham stimulation and PR (SS+PR) in a large population of moderately impaired COPD patients. Primary outcome was evaluation of effect of NMES on quadriceps strength and on exercise capacity. Secondary outcome was evaluation of effect of NMES on symptoms (dyspnoea) and quality of life.
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
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of COPD
- •Must be able to walk
排除标准
- •Previous or current diagnosis of chronic respiratory failure
- •A history of diseases other than COPD, in particular neurological disease
- •Need for treatment with systemic steroids during the rehabilitation period
结局指标
主要结局
Exercise Capacity
时间窗: 5 weeks
6 minute walk test(6MWT)
Quadriceps Strength
时间窗: 5 weeks
Quadriceps strength was assessed by means of Sit to Stand Test (STST). The subjects held their arms stationary by putting their hands on their hips. The subjects were asked to complete the sitting and standing positions without using the arms for support while rising and sitting. Once instructed, subjects stand upright and without delay sit down again, repeating the procedure as many times as possible in a 1 min period. The number of completed repetitions was recorded. The subjects were permitted to use rest periods to complete 1 min.
次要结局
- Dyspnoea(5 weeks)
- Quality of Life(5 weeks)
- Respiratory Function(5 weeks)
研究者
Ercole Zanotti
MD
Fondazione Salvatore Maugeri