Combination of Pulmonary Rehabilitation and Neuromuscular Electrical Stimulation and in COPD Patients: a Randomized Clinical Trial of Efficacy
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Chronic Obstructive Pulmonary Disease
- Sponsor
- Fondazione Salvatore Maugeri
- Enrollment
- 83
- Locations
- 1
- Primary Endpoint
- Exercise Capacity
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
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).
Detailed Description
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.
Investigators
Ercole Zanotti
MD
Fondazione Salvatore Maugeri
Eligibility Criteria
Inclusion Criteria
- •Clinical diagnosis of COPD
- •Must be able to walk
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Exercise Capacity
Time Frame: 5 weeks
6 minute walk test(6MWT)
Quadriceps Strength
Time Frame: 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.
Secondary Outcomes
- Dyspnoea(5 weeks)
- Quality of Life(5 weeks)
- Respiratory Function(5 weeks)