Neuromuscular Electrical Stimulation in Chronic Obstructive Pulmonary Disease (COPD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00677690
Recruitment Status : Completed
First Posted : May 14, 2008
Results First Posted : April 20, 2009
Last Update Posted : November 16, 2011
Information provided by (Responsible Party):
Ercole Zanotti, 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).

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Other: neuromuscular electrical stimulation (NMES) Other: Sham electrical stimulation Phase 3

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  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combination of Pulmonary Rehabilitation and Neuromuscular Electrical Stimulation and in COPD Patients: a Randomized Clinical Trial of Efficacy
Study Start Date : January 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : January 2009

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U.S. FDA Resources

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 Name: 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 Name: pulmonary rehabilitation

Primary Outcome Measures :
  1. Exercise Capacity [ Time Frame: 5 weeks ]
    6 minute walk test(6MWT)

  2. Quadriceps Strength [ Time Frame: 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 :
  1. Dyspnoea [ Time Frame: 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.

  2. Quality of Life [ Time Frame: 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).

  3. Respiratory Function [ Time Frame: 5 weeks ]
    forced expiratory volume in 1 second (FEV1)

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00677690

Fondazione Salvatore Maugeri
Montescano, Pavia, Italy, 27040
Sponsors and Collaborators
Fondazione Salvatore Maugeri
Principal Investigator: ercole zanotti, MD Fondazione Maugeri

Responsible Party: Ercole Zanotti, MD, Fondazione Salvatore Maugeri Identifier: NCT00677690     History of Changes
Other Study ID Numbers: 05/2008
First Posted: May 14, 2008    Key Record Dates
Results First Posted: April 20, 2009
Last Update Posted: November 16, 2011
Last Verified: November 2011

Keywords provided by Ercole Zanotti, Fondazione Salvatore Maugeri:

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases