Phase 3
N=83
Neuromuscular Electrical Stimulation in Chronic Obstructive Pulmonary Disease (COPD)
Chronic Obstructive Pulmonary Disease
Bottom Line
View on ClinicalTrials.gov: NCT00677690 ↗Enrolled (actual)
83
Serious AEs
—
Results posted
Apr 2009
Primary outcome: Primary: Exercise Capacity — 465.5; 462.7 meters — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- neuromuscular electrical stimulation (NMES) (Other); Sham electrical stimulation (Other)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Fondazione Salvatore Maugeri
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Exercise Capacity |
465.5; 462.7 | <0.05 sig |
| PRIMARY Quadriceps Strength |
13.5; 13.6 | <0.05 sig |
| SECONDARY Dyspnoea |
2.4; 2.6 | < 0.05 sig |
| SECONDARY Quality of Life |
41.7; 42.05 | <0.05 sig |
| SECONDARY Respiratory Function |
50.1; 49.6 | <0.05 sig |
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).
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
Data sourced from ClinicalTrials.gov (NCT00677690). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.