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Completed

NCT Number: NCT00677690

Neuromuscular Electrical Stimulation in Chronic Obstructive Pulmonary Disease (COPD)

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).

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fondazione Salvatore Maugeri

Montescano, Pavia, 27040, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuromuscular electrical stimulation (NMES)

Other

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

Sham electrical stimulation

Other

Sham stimulation was performed with the same modality and time, but the stimulus was set up at 5 Hz.

Other names: pulmonary rehabilitation

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Fondazione Salvatore Maugeri

Other

Registry information

Official study title

Combination of Pulmonary Rehabilitation and Neuromuscular Electrical Stimulation and in COPD Patients: a Randomized Clinical Trial of Efficacy

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
May 14, 2008
Registry last updated
Nov 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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