Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Combination of Pulmonary Rehabilitation and Neuromuscular Electrical Stimulation and in COPD Patients: a Randomized Clinical Trial of Efficacy
Verified date | November 2011 |
Source | Fondazione Salvatore Maugeri |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 83 |
Est. completion date | January 2009 |
Est. primary completion date | March 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 60 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Fondazione Salvatore Maugeri | Montescano | Pavia |
Lead Sponsor | Collaborator |
---|---|
Fondazione Salvatore Maugeri |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Exercise Capacity | 6 minute walk test(6MWT) | 5 weeks | Yes |
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. | 5 weeks | Yes |
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. | 5 weeks | Yes |
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). | 5 weeks | Yes |
Secondary | Respiratory Function | forced expiratory volume in 1 second (FEV1) | 5 weeks | Yes |
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