COPD Clinical Trial
Official title:
Effects of Whole Body Vibration Training in Severe Chronic Obstructive Pulmonary Disease Patients
Verified date | May 2013 |
Source | Hospital de Mataró |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Ethics Committee |
Study type | Interventional |
The investigators designed the current study with the main objective of determining whether Whole Body Vibration Training (WBVT) alone improves muscular force and/or modifies the functional capacity parameters in severe Chronic Obstructive Pulmonary Disease (COPD) patients referred to a rehabilitation programme.
Status | Completed |
Enrollment | 60 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 55 Years to 85 Years |
Eligibility |
Inclusion Criteria: - severe COPD defined as a post-bronchodilator forced expiratory volume at one second (FEV1)/ forced vital capacity (FVC) < 0.7 and FEV1 < 50% predicted, - stable disease defined as no exacerbation, - hospital admission or change in treatment in the previous 3 months. Exclusion Criteria: - other significant respiratory disease (bronchiectasis, - lung fibrosis, asthma, etc), - active smoking, - severe cardiovascular, - neurological, and/or metabolic pathology that could interfere with the results, - total hip, knee or ankle arthroplasty, - previous vitreous haemorrhage, - severe alcoholism (> 80 g/day) and - severe malnutrition (BMI < 19 Kg/m2) to reduce the risk of falling and dropouts. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Eulogio Pleguezuelos | Mataró | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Hospital de Mataró |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Complications | cardiac events, increase in respiratory symptoms, knee pain during whole body vibration training. | 3 months follow up | Yes |
Primary | isokinetic knee flexor and extensor testing muscular force | the change between basal - and 3 months follow up. | basal, 3 months follow up | Yes |
Primary | distance performed in the six minutes walking test (6MWT) | the change between basal - and 3 months follow up. | Basal, 3 months follow up | No |
Secondary | respiratory muscular strength was assessed with maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) | the change between basal - and 3 months follow up. | Basal, 3 month follow up | Yes |
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