Neuromuscular Electrical Stimulation in Chronic Obstructive Pulmonary Disease (COPD)

Phase 3

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Other: Sham electrical stimulation; Other: neuromuscular electrical stimulation (NMES)

• Registration Number: NCT00677690
• Lead Sponsor: Fondazione Salvatore Maugeri

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.

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2008-03
• Study First Submitted: 2008-05-08
• Study First Submitted QC: 2008-05-12
• Study First Posted: 2008-05-14
• Study Completion: 2009-01
• Results First Submitted: 2009-01-05
• Results First Submitted QC: 2009-04-17
• Results First Posted: 2009-04-20
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-04
• Last Update Posted: 2011-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SS+PR	Sham electrical stimulation	Patients undergone to pulmonary rehabilitation
NM+PR	neuromuscular electrical stimulation (NMES)	Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation (NM+PR)

Primary Outcome Measures

Name	Time	Method
Exercise Capacity	5 weeks	6 minute walk test(6MWT)
Quadriceps Strength	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 Outcome Measures

Name	Time	Method
Dyspnoea	5 weeks	The modified Medical Research Council (MMRC) scale was used for rating dyspnoea. MMRC is a five-point scale based on degrees of various physical activities that precipitate breathlessness. Scores on the MMRC dyspnoea scale can range from 0 (normal) to 4.
Quality of Life	5 weeks	St. George's respiratory questionnaire is a standardized self-administered airways disease-specific questionnaire divided into three subscales: symptoms (eight items), activity (16 items), and impacts (26 items). For each subscale and for the overall questionnaire, scores range from zero (no impairment) to 100 (maximum impairment).
Respiratory Function	5 weeks	forced expiratory volume in 1 second (FEV1)

Trial Locations

Locations (1)

Fondazione Salvatore Maugeri; 🇮🇹 Montescano, Pavia, Italy