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

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).

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: neuromuscular electrical stimulation (NMES); Other: Sham electrical stimulation

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 Type: Interventional
• Enrollment (Actual): 83
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Pavia
    • Montescano, Pavia, Italy, 27040
      • Fondazione Salvatore Maugeri

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NM+PR; Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation (NM+PR)	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 Names: pulmonary rehabilitation
Placebo Comparator: SS+PR; Patients undergone to pulmonary rehabilitation	Other: Sham electrical stimulation; Sham stimulation was performed with the same modality and time, but the stimulus was set up at 5 Hz.; Other Names: pulmonary rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise Capacity	6 minute walk test(6MWT)	5 weeks
Quadriceps Strength	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.	5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dyspnoea	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.	5 weeks
Quality of Life	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).	5 weeks
Respiratory Function	forced expiratory volume in 1 second (FEV1)	5 weeks

Collaborators and Investigators

• Sponsor: Fondazione Salvatore Maugeri
• Investigators: Principal Investigator: ercole zanotti, MD, Fondazione Maugeri

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: May 8, 2008
• First Submitted That Met QC Criteria: May 12, 2008
• First Posted (Estimate): May 14, 2008

Study Record Updates

• Last Update Posted (Estimate): November 16, 2011
• Last Update Submitted That Met QC Criteria: November 4, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: COPD
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 05/2008