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临床试验/CTRI/2020/02/023534
CTRI/2020/02/023534已完成不适用

Evaluating the effect of Yoga in Management of Asthma: A Single Blind Randomized Controlled Trial.

Uttarakhand state council for science technologyUCOST1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年1月3日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
1.Pulmonary function test including FeV1, FVC

研究概览

简要总结

Background:

Asthma is one of the common non-communicable diseases (NCDs). It affects around 339 million people in all regions of the world. It is a cause of substantial burden of disease, including both premature death and reduced quality of life, in people of all ages in all parts of the world.Asthma’s principal symptoms result primarily from bronchoconstriction and a resulting reduction in airflow. These symptoms include shortness of breath, cough, wheezing, and chest pain or tightness. The associated reduction in airflow is usually reversible spontaneously or with treatment.

Material and methods:

A Randomized controlled trial will be conducted on 200 asthmatic patients. The subjects will be recruited from out-patient department of Pulmonary Medicine, All India Institute of Medical Sciences, Rishikesh. Patients will be allocated to two groups: group A (Intervention group) and group B (control group). Patients in group A will be treated with pre-designed yogic practices along with conventional medical therapy for 30 minutes every day for a period of 3 months. Group B will be treated with conventional medication and joints loosening exercises for 30 minutes every day for a period of 3 months. Subjective assessment, spirometry indices including Forced Expiratory Volume in first second (FEV1%), Peak Expiratory Flow Rate (PEFR) and quality of life will be done every month in both the groups uptill 6 months from baseline.

Statistical analysis:

Statistical methods used to compare group outcomes will be T test, repeated measures ANOVA and Chi Square using intention to treat analysis method. A p value of <0.05 would be considered significant.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

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

入选标准

  • Stable patients not in exacerbation in last one month
  • Mild to moderate -as per GINA- Global initiative for Asthma guideline.

排除标准

  • 1.Patients with other ailments which can hamper with yoga protocol such as Musculoskeletal disorder, cervical, back pain 2.Arthritis, hypertension, other major disease 3.Not willing to participate in the study.

结局指标

主要结局

1.Pulmonary function test including FeV1, FVC

时间窗: After baseline data collection we will take 1st follow up in 4th week, 2nd follow up in 8th week and 3rd follow up in 12th week

2.Health related Quality of life (SGRQ score)

时间窗: After baseline data collection we will take 1st follow up in 4th week, 2nd follow up in 8th week and 3rd follow up in 12th week

3.Spirometer pre and post bronchodilator

时间窗: After baseline data collection we will take 1st follow up in 4th week, 2nd follow up in 8th week and 3rd follow up in 12th week

4.Exacerbation (frequency of attacks)

时间窗: After baseline data collection we will take 1st follow up in 4th week, 2nd follow up in 8th week and 3rd follow up in 12th week

5.Asthma control test

时间窗: After baseline data collection we will take 1st follow up in 4th week, 2nd follow up in 8th week and 3rd follow up in 12th week

次要结局

  • 1.Airway reactance and resistance(2.HRV biofeedback will be done to assess the effect of yoga)

研究者

发起方
Uttarakhand state council for science technologyUCOST
申办方类型
Government funding agency

研究点 (1)

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