Trials / Completed
CompletedNCT00677690
Neuromuscular Electrical Stimulation in Chronic Obstructive Pulmonary Disease (COPD)
Combination of Pulmonary Rehabilitation and Neuromuscular Electrical Stimulation and in COPD Patients: a Randomized Clinical Trial of Efficacy
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 83 (actual)
- Sponsor
- Fondazione Salvatore Maugeri · Academic / Other
- Sex
- All
- Age
- 60 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | neuromuscular electrical stimulation (NMES) | NMES was applied by means of a commercially available four channel electrostimulator which generated a symmetrical biphasic pulsed current. Each session lasted 30 minutes and was performed 5 days/week for 5 weeks. |
| OTHER | Sham electrical stimulation | Sham stimulation was performed with the same modality and time, but the stimulus was set up at 5 Hz. |
Timeline
- Start date
- 2007-01-01
- Primary completion
- 2008-03-01
- Completion
- 2009-01-01
- First posted
- 2008-05-14
- Last updated
- 2011-11-16
- Results posted
- 2009-04-20
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT00677690. Inclusion in this directory is not an endorsement.