A Phase 3 interventional study of neuromuscular electrical stimulation (NMES) and Sham electrical stimulation in Chronic Obstructive Pulmonary Disease, sponsored by Fondazione Salvatore Maugeri. Completed at 1 site in Italy. Open to participants aged 60 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-11-16.
Sponsored by Fondazione Salvatore Maugeri · Phase 3, Interventional, and Treatment
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).
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.
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This study's enrollment of 83 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
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Exclusion Criteria:
Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation (NM+PR)
Other: neuromuscular electrical stimulation (NMES)
Patients undergone to pulmonary rehabilitation
Other: Sham electrical stimulation
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.
Also known as: pulmonary rehabilitation
Sham stimulation was performed with the same modality and time, but the stimulus was set up at 5 Hz.
Also known as: pulmonary rehabilitation
Exercise Capacity
6 minute walk test(6MWT)
Time frame: 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.
Time frame: 5 weeks
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.
Time frame: 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).
Time frame: 5 weeks
Respiratory Function
forced expiratory volume in 1 second (FEV1)
Time frame: 5 weeks
2007-2008 - Rehabilitative Pulmonary ward
| Milestone | Neuromuscular Stimulation and Pulmonary Rehabilitation | Pulmonary Rehabilitation |
|---|---|---|
| Started | 42 | 41 |
| Completed | 42 | 41 |
| Not completed | 0 | 0 |
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.
| units on a scale | Neuromuscular Stimulation and Pulmonary Rehabilitation | Pulmonary Rehabilitation |
|---|---|---|
| Dyspnoea | 2.4 ± 0.4 | 2.6 ± 0.2 |
6 minute walk test(6MWT)
| meters | Neuromuscular Stimulation and Pulmonary Rehabilitation | Pulmonary Rehabilitation |
|---|---|---|
| Exercise Capacity | 465.5 ± 101.7 | 462.7 ± 96.9 |
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).
| units on a scale | Neuromuscular Stimulation and Pulmonary Rehabilitation | Pulmonary Rehabilitation |
|---|---|---|
| Quality of Life | 41.7 ± 14.8 | 42.05 ± 15.7 |
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.
| repetitions | Neuromuscular Stimulation and Pulmonary Rehabilitation | Pulmonary Rehabilitation |
|---|---|---|
| Quadriceps Strength | 13.5 ± 0.83 | 13.6 ± 0.99 |
forced expiratory volume in 1 second (FEV1)
| percentage of predicted value | Neuromuscular Stimulation and Pulmonary Rehabilitation | Pulmonary Rehabilitation |
|---|---|---|
| Respiratory Function | 50.1 ± 6.4 | 49.6 ± 8.2 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Neuromuscular Stimulation and Pulmonary Rehabilitation | — | — | — |
| Pulmonary Rehabilitation | — | — | — |
| Age, Categorical(Participants) | Neuromuscular Stimulation and Pulmonary Rehabilitation | Pulmonary Rehabilitation | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 11 | 9 | 20 |
| >=65 years | 31 | 32 | 63 |
| Age Continuous(years) | Neuromuscular Stimulation and Pulmonary Rehabilitation | Pulmonary Rehabilitation | Total |
|---|---|---|---|
| Mean | 61.4 ± 7.6 | 62.8 ± 5.4 | 62.1 ± 8.4 |
| Sex: Female, Male(Participants) | Neuromuscular Stimulation and Pulmonary Rehabilitation | Pulmonary Rehabilitation | Total |
|---|---|---|---|
| Female | 11 | 12 | 23 |
| Male | 31 | 29 | 60 |
| Region of Enrollment(participants) | Neuromuscular Stimulation and Pulmonary Rehabilitation | Pulmonary Rehabilitation | Total |
|---|---|---|---|
| Italy | 42 | 41 | 83 |
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Fondazione Salvatore Maugeri