Neuromuscular Electrical Stimulation in Chronic Obstructive Pulmonary Disease (COPD)

Fondazione Salvatore Maugeri

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Other: Sham electrical stimulation; Other: neuromuscular electrical stimulation (NMES)

Study type: Interventional

Funder types: Other

Identifiers

NCT00677690

05/2008

Details and patient eligibility

About

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).

Full 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.

Enrollment: 83 patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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83 participants in 2 patient groups, including a placebo group

NM+PR

Active Comparator group

Description:

Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation (NM+PR)

Treatment:

Other: neuromuscular electrical stimulation (NMES)

SS+PR

Placebo Comparator group

Description:

Patients undergone to pulmonary rehabilitation

Treatment:

Other: Sham electrical stimulation