Effect of deep breathing exercise along with pharmacotherapy in COPD Assessment Test score (CAT score) as compared to pharmacotherapy alone in patients with mild to moderate chronic obstructive pulmonary disease attending a tertiary care center in south Kerala.
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Difference in CAT score between two groups.
Study Overview
Brief Summary
Rationale -
Deep breathing exercises (DBE) have shown betterment of pulmonary function in COPD patients. Previous studies have proposed DBE as an adjunct treatment in COPD. But in the majority of them, the time range of exercise is not fixed, which can cause subjective change in exercise performance. By this study we are aiming to elucidate the effect of Deep Breathing Exercise (DBE) with a fixed time limit on each cycle in stable COPD patients, with the help of COPD assessment test score (CAT). By fixing the time range of exercise , it’s expected to eliminate subjective errors in performing the same.
Research question
- Is Deep breathing exercise (DBE) along with pharmacotherapy, better than pharmacotherapy alone in improving CAT score among patients with mild to moderate COPD.
- Is DBE along with pharmacotherapy, better than pharmacotherapy alone in improving cardiovascular function among patients with mild to moderate COPD.
Objectives -
Primary objective: To compare CAT score of COPD patients receiving DBE and pharmacotherapy; with COPD patients receiving pharmacotherapy alone after 4 weeks of DBE.
Secondary objectives: To compare cardiovascular parameters of COPD patients receiving DBE and pharmacotherapy; with COPD patients receiving pharmacotherapy alone after 4 weeks of DBE.
Methodology
Chronic Obstructive Pulmonary Disease - COPD patients fulfilling inclusion and exclusion criteria and giving consent will be randomly allotted to interventional and control groups using block randomisation method. Allocation concealment will be done using sealed envelope technique. Initial values of CAT score, blood pressure and heart rate are recorded.
The interventional group will be given training on deep breathing exercises - alternate nostril breathing exercise and pursed lip breathing exercise. Subjects will be monitored to assure that they perform these exercises for 10 minutes twice daily for a period of 4 weeks.
At the end of 4 weeks difference in final values between two groups will be compared as - 1) Difference in CAT score, 2) Difference in blood pressure, 3) Difference in heart rate by suitable statistical tests.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 40.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •COPD patients with mild to moderate disease undergoing regular pharmacotherapy.
Exclusion Criteria
- •Patients on treatment for cardiovascular or renal diseases.
- •Patients having musculoskelatal abnormalities of chest wall.
Outcomes
Primary Outcomes
Difference in CAT score between two groups.
Time Frame: Six weeks
Secondary Outcomes
- Difference in blood pressure and heart rate values between two groups.(Six weeks)
Investigators
Jithin J
Pushpagiri Institute of Medical Sciences and Research Center.
