Effects of Yoga on Clinical Impact and Psychosocial Aspects of COPD

Chronic Pulmonary Obstructive Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02539524
• Other study ID #: 102838/2014
• Status: Completed
• Phase: N/A
• First received: August 28, 2015
• Last updated: September 12, 2016
• Start date: January 2015
• Est. completion date: December 2015

Study information

• Verified date: September 2016
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Chronic Pulmonary Obstructive Disease

Intervention

Other:
• Yoga bhastrika pranayama breathing exercise
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.
• Pulmonary Rehabilitation
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.

Locations

Country	Name	City	State
Brazil	Pulmonary and Rehabilitation Ambulatory of the Clinical Hospital of the University of São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

Brown RP, Gerbarg PL. Sudarshan Kriya yogic breathing in the treatment of stress, anxiety, and depression: part I-neurophysiologic model. J Altern Complement Med. 2005 Feb;11(1):189-201. Review. Erratum in: J Altern Complement Med. 2005 Apr;11(2):383-4. — View Citation

Donesky-Cuenco D, Nguyen HQ, Paul S, Carrieri-Kohlman V. Yoga therapy decreases dyspnea-related distress and improves functional performance in people with chronic obstructive pulmonary disease: a pilot study. J Altern Complement Med. 2009 Mar;15(3):225-34. doi: 10.1089/acm.2008.0389. — View Citation

Pomidori L, Campigotto F, Amatya TM, Bernardi L, Cogo A. Efficacy and tolerability of yoga breathing in patients with chronic obstructive pulmonary disease: a pilot study. J Cardiopulm Rehabil Prev. 2009 Mar-Apr;29(2):133-7. doi: 10.1097/HCR.0b013e31819a0227. — View Citation

Rabe KF, Hurd S, Anzueto A, Barnes PJ, Buist SA, Calverley P, Fukuchi Y, Jenkins C, Rodriguez-Roisin R, van Weel C, Zielinski J; Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2007 Sep 15;176(6):532-55. Epub 2007 May 16. Review. — View Citation

Santaella DF, Devesa CR, Rojo MR, Amato MB, Drager LF, Casali KR, Montano N, Lorenzi-Filho G. Yoga respiratory training improves respiratory function and cardiac sympathovagal balance in elderly subjects: a randomised controlled trial. BMJ Open. 2011 May 24;1(1):e000085. doi: 10.1136/bmjopen-2011-000085. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in COPD Clinical Impact	Evaluated by COPD Assessment Test Questionnaire	Baseline and 12 weeks	No
Secondary	Changes in Anxiety and Depression Scale	Evaluated by Hospital Anxiety and Depression Scale	Baseline and 12 weeks	No
Secondary	Changes in Quality of Life Questionnaire	Evaluated by self-reported Chronic Respiratory Questionnaire	Baseline and 12 weeks	No