Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Effect of Inspiratory Muscle Training on Exercise Performance and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease
Verified date | October 2014 |
Source | Mansoura University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Egypt: Mansoura University |
Study type | Interventional |
The aim is to study effectiveness of inspiratory muscle training as a part of exercise training in patients with Chronic Obstructive Pulmonary Disease (COPD) and if it adds to general exercise training program in regard to respiratory muscle strength, dyspnea, exercise performance and quality of life.
Status | Completed |
Enrollment | 60 |
Est. completion date | April 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 45 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Exsmokers - Low PImax compared to reference values [lower limits of normal: 80 cmH2O for patients less than or equal 54 years old; 71 cmH2O for patients' age between 55-64 years; and 65 cmH2O for patients 65 years old ]. - Stable patients without history of exacerbation or hospitalization four weeks before starting the study. Exclusion Criteria: - Lack of motivation and compliance. - Patients with significant reversibility following bronchodilation defined as an increase in FEV1 of more than 12% and 200 ml from the pre-bronchodilator value - Unstable cardiac disease [severe heart failure, dangerous dysrhythmias, recent myocardial infarction or unstable angina (within 4 weeks)]. - Uncontrolled hypertension - Recent pneumothorax (within 6 weeks) - Recent abdominal or thoracic surgery (within 6 weeks) - Known progressive neuromuscular disorders - Recent gastrointestinal bleeding (within 4 weeks) - Current smokers - Active cancer - Patients with advanced liver diseases, or renal impairment. - Known connective tissue diseases - Significant endocrinal abnormalities |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Mansoura University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | changes in respiratory muscle strength | maximal inspiratory pressure, maximal expiratory pressure | after 4 weeks and after 8 weeks of study | No |
Primary | changes in perception of dyspnea | modified Medical Research Council and modified Borg category scale | after 4 weeks and after 8 weeks of study | No |
Primary | changes in exercise performance | 6-min walk test | after 4 weeks and after 8 weeks of study | No |
Primary | changes in quality of life | BODE index, St. George's Respiratory Questionnaire for COPD patients (SGRQ-C) | after 4 weeks and after 8 weeks of study | No |
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