Clinical Trials Directory

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

TypeNameDescription
OTHERneuromuscular 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.
OTHERSham electrical stimulationSham 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.