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临床试验/NCT02539524
NCT02539524已完成不适用

Effects of Yoga Respiratory Exercises on Clinical Impact, and Psychosocial Aspects in Patients With Chronic Obstructive Pulmonary Disease

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
2
主要终点
Changes in COPD Clinical Impact

研究概览

简要总结

The aim of this study is to investigate weather the breathing exercises of Yoga are effective in altering clinical impact, anxiety, depression and quality of life in Chronic Obstructive Pulmonary Disease patients.

详细描述

Introduction According to the Global Initiative for Chronic Lung Disease (GOLD), chronic obstructive pulmonary disease (COPD) is a common, preventable and treatable disease, characterized by a persistent not totally reversible limitation of air flow, with a progressively characteristic associated to the increase of inflammatory lungs and air pathways reactions to gas and harmful particles. It is one of the main morbid-mortality causes world wide and, thus, a social health matter. Dyspnoea is a recurrent stressful symptom of COPD, and is usually followed by anxiety, depression, and decreased quality of life.

Some studies have addressed the tolerance of yoga breathing exercises by COPD patients, and some have indeed found a decreased functional load of dyspnoea in such patients.

Thus, the aim of this study is to investigate the effects of the regular practice (training) of respiratory Yoga exercises (pranayamas) on the clinical impact and psychosocial aspects: anxiety, depression and quality of life in COPD patients as a complementary therapy to pulmonary rehabilitation.

Methods Participants Diagnosed COPD patients will be recruited from the Pulmonary Rehabilitation Ambulatory of the Clinical Hospital of the Faculty of Medicine of the University of São Paulo (HC-FMUSP). All participants will give written consent to participate of the study, and will be able to exit the study at any point without having to explain the reason.

Sample Size Calculation Based on effect expected proportion in controls of 0.05, assuming an odds ratio of 25, in a confidence level of 0.95, and a power of 0.8, the sample size for each group was 9, in a total sample size (both groups) of 18 participants.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
50 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • COPD diagnosed classified as B, C or D according to the Global Initiative for Obstructive Lung Disease (GOLD);
  • Optimized medical treatment.

排除标准

  • Any other lung disease;
  • Home use of oxygen therapy;
  • Respiratory Yoga exercise training in the last 2 years;
  • Current smokers.

结局指标

主要结局

Changes in COPD Clinical Impact

时间窗: Baseline and 12 weeks

Evaluated by COPD Assessment Test Questionnaire

次要结局

  • Changes in Anxiety and Depression Scale(Baseline and 12 weeks)
  • Changes in Quality of Life Questionnaire(Baseline and 12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Danilo Forghieri Santaella

Ph.D.

University of Sao Paulo

研究点 (2)

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