Neuromuscular Electrical Stimulation in Chronic Obstructive Pulmonary Disease (COPD)
This study has been completed.
Sponsor:
Fondazione Salvatore Maugeri
Information provided by (Responsible Party):
Ercole Zanotti, Fondazione Salvatore Maugeri
ClinicalTrials.gov Identifier:
NCT00677690
First received: May 8, 2008
Last updated: November 4, 2011
Last verified: November 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease |
Other: neuromuscular electrical stimulation (NMES) Other: Sham electrical stimulation |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
MedlinePlus related topics:
COPD (Chronic Obstructive Pulmonary Disease)
Exercise and Physical Fitness
Rehabilitation
U.S. FDA Resources
Further study details as provided by Fondazione Salvatore Maugeri:
Primary Outcome Measures:
- Exercise Capacity [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]6 minute walk test(6MWT)
- Quadriceps Strength [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]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:
- Dyspnoea [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]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 [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]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 [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]forced expiratory volume in 1 second (FEV1)
| Enrollment: | 83 |
| Study Start Date: | January 2007 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 60 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Ercole Zanotti, MD, Fondazione Salvatore Maugeri |
| ClinicalTrials.gov Identifier: | NCT00677690 History of Changes |
| Other Study ID Numbers: | 05/2008 |
| Study First Received: | May 8, 2008 |
| Results First Received: | January 5, 2009 |
| Last Updated: | November 4, 2011 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by Fondazione Salvatore Maugeri:
|
COPD |
Additional relevant MeSH terms:
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 18, 2013