Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD
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).
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.
Interventions
OTHERneuromuscular 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.
Sham stimulation was performed with the same modality and time, but the stimulus was set up at 5 Hz.
Sponsors
Fondazione Salvatore Maugeri
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exercise Capacity | 5 weeks | 6 minute walk test(6MWT) |
| Quadriceps Strength | 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
| Measure | Time frame | Description |
|---|---|---|
| Dyspnoea | 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. |
| Quality of Life | 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). |
| Respiratory Function | 5 weeks | forced expiratory volume in 1 second (FEV1) |
Countries
Italy
Participant flow
Recruitment details
2007-2008 - Rehabilitative Pulmonary ward
Pre-assignment details
167 COPD patients were admitted.52 out of 167 did not meet the inclusion criteria.19 out of the remaining 115 patients refused to participate.13 out of 96 subjects subsequently dropped out due to acute exacerbation.Our definitive sample was therefore of 83 subjects
Participants by arm
| Arm | Count |
|---|---|
| Neuromuscular Stimulation and Pulmonary Rehabilitation Patients undergone to combination of neuromuscular stimulation and pulmonary rehabilitation | 42 |
| Pulmonary Rehabilitation Patients undergone to pulmonary rehabilitation | 41 |
| Total | 83 |
Baseline characteristics
| Characteristic | Total | Neuromuscular Stimulation and Pulmonary Rehabilitation | Pulmonary Rehabilitation |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 63 Participants | 31 Participants | 32 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 11 Participants | 9 Participants |
| Age Continuous | 62.1 years STANDARD_DEVIATION 8.4 | 61.4 years STANDARD_DEVIATION 7.6 | 62.8 years STANDARD_DEVIATION 5.4 |
| Region of Enrollment Italy | 83 participants | 42 participants | 41 participants |
| Sex: Female, Male Female | 23 Participants | 11 Participants | 12 Participants |
| Sex: Female, Male Male | 60 Participants | 31 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Exercise Capacity
6 minute walk test(6MWT)
Time frame: 5 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neuromuscular Stimulation and Pulmonary Rehabilitation | Exercise Capacity | 465.5 meters | Standard Deviation 101.7 |
| Pulmonary Rehabilitation | Exercise Capacity | 462.7 meters | Standard Deviation 96.9 |
p-value: <0.05t-test, 1 sided
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neuromuscular Stimulation and Pulmonary Rehabilitation | Quadriceps Strength | 13.5 repetitions | Standard Deviation 0.83 |
| Pulmonary Rehabilitation | Quadriceps Strength | 13.6 repetitions | Standard Deviation 0.99 |
p-value: <0.05t-test, 1 sided
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neuromuscular Stimulation and Pulmonary Rehabilitation | Dyspnoea | 2.4 units on a scale | Standard Deviation 0.4 |
| Pulmonary Rehabilitation | Dyspnoea | 2.6 units on a scale | Standard Deviation 0.2 |
Comparison: All data were expressed as the mean ± SD. The level of significance for all tests was set at p \< 0.05.~Inter- and intra-group comparisons were performed using both paired and unpaired t tests for continuous variables and Chi squared for categorical variables.p-value: <0.05t-test, 1 sided
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neuromuscular Stimulation and Pulmonary Rehabilitation | Quality of Life | 41.7 units on a scale | Standard Deviation 14.8 |
| Pulmonary Rehabilitation | Quality of Life | 42.05 units on a scale | Standard Deviation 15.7 |
p-value: <0.05t-test, 1 sided
Secondary
Respiratory Function
forced expiratory volume in 1 second (FEV1)
Time frame: 5 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neuromuscular Stimulation and Pulmonary Rehabilitation | Respiratory Function | 50.1 percentage of predicted value | Standard Deviation 6.4 |
| Pulmonary Rehabilitation | Respiratory Function | 49.6 percentage of predicted value | Standard Deviation 8.2 |
p-value: <0.05t-test, 1 sided