Effects of Yoga on Clinical Impact and Psychosocial Aspects of COPD

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Experimental Design This is a randomized controlled prospective clinical trial, with two groups: pulmonary rehabilitation for control group (PRG) and pulmonary rehabilitation plus Yoga group (YG).Randomization was carried out by numbered paper draw: 20 papers numbered from 1-20 were put in a bag from which participants took 1 paper each. Even numbers indicated PRG and odd ones indicated YG. Medication will not altered during study. Both groups will perform a 12-week pulmonary rehabilitation program, besides that, YG will perform 24 Yoga breathing sessions (2 times a week). Participants of both groups will answer questionnaires to evaluate clinical impact, anxiety, depression and quality of life at study entry and after 12 weeks. Yoga Breathing Exercises Breathing exercises will be based on traditional Hatha Yoga texts (Hathapradipika and Gheranda Samhita). The chosen exercise was bhastrika pranayama (kapalabhati followed by surya bedhana). Kapalabhhati consists basically of 20 fast and vigorous abdominal contractions for expiration, followed by immediate and maximal relaxation of these muscles for inspiration, and surya bedhana is a slow inspiration through the right nostril, followed by a comfortable apnoea for the same time of air intake, and a slower yet comfortable expiration through the left nostril. During training, participants will be considered at peak training when they are able to perform 10 sets of bhastrika. Pulmonary Rehabilitation will consist of 30 minutes of aerobic training (cycloergometer or treadmill) followed by resistance exercises for lower and upper limbs. Evaluations Clinical impact of COPD will be accessed by the COPD Assessment Test; anxiety will be evaluated by Hospital Anxiety and Depression Scale; Quality of Life will be accessed by the self-reported Chronic Respiratory Questionnaire. Statistical Analysis Intra-group comparisons between moments (pre vs. post treatment) will be done using a paired Student T-test (repeated measures). While inter-groups comparisons (PRG vs. YG) will be done using the independent measures Student T-test. Significance will be accepted when p<0.05. SPSS v.21 software will be used to process analysis.

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

Conditions
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Chronic Pulmonary Obstructive Disease

Intervention / Treatment
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* Other: Yoga bhastrika pranayama breathing exercise
* Other: Pulmonary Rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COPD diagnosed classified as B, C or D according to the Global Initiative for Obstructive Lung Disease (GOLD); Optimized medical treatment. Exclusion Criteria: Any other lung disease; Home use of oxygen therapy; Respiratory Yoga exercise training in the last 2 years; Current smokers.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pulmonary Rehabilitation Group<br>Pulmonary Rehabilitation Group Intervention consisted of 12-week pulmonary rehabilitation. Two 1 hour sessions a week, consisting of: 30 min of aerobic training followed by resistance exercises for upper and lower limbs. | Other: Pulmonary Rehabilitation<br>* Pulmonary Rehabilitation Group Intervention consisted of 12-week pulmonary rehabilitation. Two 1 hour sessions a week, consisting of: 30 min of aerobic training followed by resistance exercises for upper and lower limbs.<br>|
| Experimental: Yoga Group<br>Yoga Bhastrika Pranayama breathing exercises consisted of: 12-week pulmonary rehabilitation (two 1 hour sessions a week, consisting of: 30 min of aerobic training followed by resistance exercises for upper and lower limbs). After each pulmonary rehabilitation session, participants of this group performed 10 bhastrika pranayama breathing exercises (1 bhastrika is formed by 20 kapalabhati followed by 1 surya bedhana - described earlier). | Other: Yoga bhastrika pranayama breathing exercise<br>* Bhastrika Pranayama is formed by a set of 20 nasal forced and rapid expirations, followed by passive nasal inspirations, followed by 1 alternate nasal breath which always begins through the right nostril, and has a retention between intake and outflow. The set of this breathing exercise is supposed to bring respiratory relief.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in COPD Clinical Impact | Evaluated by COPD Assessment Test Questionnaire | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Anxiety and Depression Scale | Evaluated by Hospital Anxiety and Depression Scale | Baseline and 12 weeks | 
| Changes in Quality of Life Questionnaire | Evaluated by self-reported Chronic Respiratory Questionnaire | Baseline and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clinical impact, anxiety, quality of life, Yoga