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临床试验/CTRI/2024/03/064183
CTRI/2024/03/064183尚未招募3 期

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.

Dr Jithin J1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2024年3月27日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
68
试验地点
1
主要终点
Difference in CAT score between two groups.

研究概览

简要总结

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

  1. Is Deep breathing exercise (DBE) along with pharmacotherapy, better than pharmacotherapy alone in improving  CAT score among patients with mild to moderate COPD.
  2. 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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
40.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • COPD patients with mild to moderate disease undergoing regular pharmacotherapy.

排除标准

  • Patients on treatment for cardiovascular or renal diseases.
  • Patients having musculoskelatal abnormalities of chest wall.

结局指标

主要结局

Difference in CAT score between two groups.

时间窗: Six weeks

次要结局

  • Difference in blood pressure and heart rate values between two groups.(Six weeks)

研究者

发起方
Dr Jithin J
申办方类型
Other [Primary Investigator]
责任方
Principal Investigator
主要研究者

Jithin J

Pushpagiri Institute of Medical Sciences and Research Center.

研究点 (1)

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