The Effect of Pranayama Breathing Technique on Asthma Control, Pulmonary Function and Quality of Life

Asthma Clinical Trial

Official title:

The Effect of Pranayama Breathing Technique on Asthma Control, Pulmonary Function and Quality of Life: A Single-Blind Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04110951
• Other study ID #: TDK-2017-7652
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: May 17, 2019

Study information

• Verified date: September 2019
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Most of the asthma patients prefer complementary and integrative applications as they continue to experience asthma symptoms despite pharmacological treatment. Pranayama, one of these treatments, is a breathing-based technique and is a part of yoga, an ancient Indian science. This study was carried out as randomized controlled single blind study in order to analyze the effect of pranayama breathing technique applied to individuals suffering from asthma on asthma control, pulmonary functions and quality of life. The study comprised 50 patients in total, as 25 patients in pranayama group and 25 patients in control group. The approval of ethics committee, permissions from the institutions, and informed voluntary approval of the individuals were obtained to conduct the research. The data of the research were collected through the application of Asthma Control Test (ACT), Asthma Quality of Life Questionnaire (AQLQ), pulmonary function test (PFT), and patient observation chart. Pranayama breathing technique was applied to pranayama group 20 minutes once a day for four weeks, and relaxation technique was applied to relaxation group similarly in addition to standard treatment. ACT, AQLQ, and PFT were evaluated twice as before and after the one month of application process. Meanwhile, the patients' PEF measurements were followed with individual PEF meter on daily basis. The value of p<0.05 was accepted statistically significant in the data analyses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 17, 2019
• Est. primary completion date: December 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Can communicate,

• To have an increase of %12 or 200 ml in FEV1 value after inhaler bronchodilator at breathing function test,

• To have chronic asthma diagnose with 6 months approved by doctors and receiving treatment,

• Asthma controls are not under control or partly under control in relation to GINA (Global Initiative for Asthma) values,

• Taking beta2-agonist and/or ICS twice a week or more to control asthma symptoms,

• There is not any chance in inhaler bronchodilator drug potions during the last four weeks,

• Can use a smart phone.

Exclusion Criteria:

• To have lung diseases such as COPD,

• To have tuberculosis and respiratory infection,

• To have diabetes and coronary artery disease,

• Smokers

• Pregnant or nursing mother,

• Doing regular exercise,

• Benefitng from other complementary and integrative health applications during treatments

Related Conditions & MeSH terms

• Asthma
• Respiratory Aspiration

Intervention

Behavioral:
• Pranayama Breathing Technique
Yogic Breathing Technique
• Relaxation technique
Progressive relaxation technique

Locations

Country	Name	City	State
Turkey	Nevsehir Haci Bektas Veli Üniversitesi	Nevsehir	Nerkez

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

References & Publications (25)

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Aggarwal T, Khatri A, Siddiqui SS, Hasan SN, Singh D, Kulshreshtha M, Agarwal S. Pranayama has additive beneficial effects along with medication in bronchial asthma patients. Journal of Physiology and Pharmacology Advances, 2013; 3(12): 292-297.

Agnihotri S, Kant S, Mishra SK, Verma A. Assessment of significance of Yoga on quality of life in asthma patients: A randomized controlled study. Ayu. 2017 Jan-Jun;38(1-2):28-32. doi: 10.4103/ayu.AYU_3_16. — View Citation

Arulmozhi S, Joice SP, Maruthy KN. Effect of pranayama on respiratory muscle strength in chronic asthmatics. National Journal of Physiology, Pharmacy and Pharmacology, 2018; 8(12): 1700-1703.

Bhatt A, Rampallivar S. Effect of pranayam on ventilatory functions in patients of bronchial asthma. Journal of evolution of medical and dental sciences-jemds, 2016; 5(28): 1453-1455.

Cooper S, Oborne J, Newton S, Harrison V, Thompson Coon J, Lewis S, Tattersfield A. Effect of two breathing exercises (Buteyko and pranayama) in asthma: a randomised controlled trial. Thorax. 2003 Aug;58(8):674-9. — View Citation

Cowie RL, Conley DP, Underwood MF, Reader PG. A randomised controlled trial of the Buteyko technique as an adjunct to conventional management of asthma. Respir Med. 2008 May;102(5):726-32. doi: 10.1016/j.rmed.2007.12.012. Epub 2008 Jan 31. — View Citation

Flüge T, Richter J, Fabel H, Zysno E, Weller E, Wagner TO. [Long-term effects of breathing exercises and yoga in patients with bronchial asthma]. Pneumologie. 1994 Jul;48(7):484-90. German. — View Citation

George M, Topaz M. A systematic review of complementary and alternative medicine for asthma self-management. Nurs Clin North Am. 2013 Mar;48(1):53-149. doi: 10.1016/j.cnur.2012.11.002. Epub 2013 Jan 10. Review. — View Citation

Gulati K, Babita R. A clinical study to evaluate the effects of yogic intervention on pulmonary functions, inflammatory markers and quality of life in patients of bronchial asthma. EC Pharmacology and Toxicology, 2017; 3: 174-181.

Hoang KAT, Nguyen HM. The effectiveness of practicing pranayama yoga on some respiratory indicators in patients suffering from bronchial disease. International Journal of Science Culture and Sport (IntJSCS), 2015; 3(2): 6-12.

Holloway EA, West RJ. Integrated breathing and relaxation training (the Papworth method) for adults with asthma in primary care: a randomised controlled trial. Thorax. 2007 Dec;62(12):1039-42. Epub 2007 Jun 15. — View Citation

Hussein NA, Afify AM, Obaya HE, Rafea AS. Effects of Ujjayi Pranayama Trainning on Selected Ventilatory Function Test in Patients with Mild Bronchial Asthma. Med. J. Cairo Univ., 2016; 84(2): 445-452.

Jerath R, Edry JW, Barnes VA, Jerath V. Physiology of long pranayamic breathing: neural respiratory elements may provide a mechanism that explains how slow deep breathing shifts the autonomic nervous system. Med Hypotheses. 2006;67(3):566-71. Epub 2006 Apr 18. — View Citation

Kant S, Agnihotri S. Asthma diagnosis and treatment-1029. Yoga as an adjuvant therapy in asthma management. In World Allergy Organization Journal, 2013; 6(1): 28.

Karam M, Kaur BP, Baptist AP. A modified breathing exercise program for asthma is easy to perform and effective. J Asthma. 2017 Mar;54(2):217-222. doi: 10.1080/02770903.2016.1196368. Epub 2016 Jun 10. — View Citation

Karmakar S, Karmakar S. The Role of Yoga in Bronchial Asthma. J Complement Med Alt Healthc. J, 2018; 7(2): 1-4.

Malarvizhi M, Maheshkumar K. Effect of 6 months of yoga practice on quality of life among patient with asthma: a randomized control trial. Advances in Integrative Medicine, 2018, 1-8.

Manivannan D. Effect of Yoga Therapy on Clinical Profile and PEFR among Women with Bronchial Asthma. Indian Journal of Ancient Medicine and Yoga, 2017; 10(4): 125-130.

Manocha R, Marks GB, Kenchington P, Peters D, Salome CM. Sahaja yoga in the management of moderate to severe asthma: a randomised controlled trial. Thorax. 2002 Feb;57(2):110-5. — View Citation

Morse D. Yoga for asthma. International Journal of Yoga Therapy, 2007; 17(1): 81-88. Morse, 2007

Murthy KJ, Sahay BK, Sitaramaraju P, Sunita M, Yogi R, Annapurna N, Ramesh M, Prasad V, Reddy E. Effect of pranayama (rechaka, puraka and kumbaka) on bronchial asthma-an open study. Lung India, 1984; 2(2): 187-191.

Nagarathna R, Nagendra HR. Yoga for bronchial asthma: a controlled study. Br Med J (Clin Res Ed). 1985 Oct 19;291(6502):1077-9. — View Citation

Pandit DP, Vaidya SM. Effect of yoga on pulmonary function tests in patients of bronchial asthma. International Journal 2013; 2(3): 58-63.

Prem V, Sahoo RC, Adhikari P. Comparison of the effects of Buteyko and pranayama breathing techniques on quality of life in patients with asthma - a randomized controlled trial. Clin Rehabil. 2013 Feb;27(2):133-41. doi: 10.1177/0269215512450521. Epub 2012 Jul 26. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma Control Test	Asthma Control Test (ACT) is composed of 5 main sections involving asthma influence level of patients due to daily actions of patients, frequency of asthma symptoms at daytimes and nights, need of urgent relaxing drug, and evaluation of disease by patients. Patients are required to respond each question with values between 1 and 5. Total score of these 5 questions ranges between 5 and 25	change from baseline score at the end of one month
Primary	Asthma Quality of Life Questionnaire	Standard Asthma Quality of Life Questionnaire (AQLQ) is a quality of life questionnaire specific to asthma comprising 32 questions. AQLQ was developed by Juniper et al. (1993) to use in clinical studies. The questionnaire evaluates responses through a 7 scores scale (1: severely impaired; 7: not impaired at all) based on changes in last two weeks regarding asthma. Standard AQLQ involves 12 questions about symptoms, 11 questions about activity limitation, 5 questions about emotional functions, and 4 questions about environment stimuli. Mean scores are calculated for subcategories and overall scores. The mean of obtained scores are evaluated between 1 and 7. The minimum score change clinically accepted important in the questionnaire is 0.50 and this situation is called "minimal significant difference" .	change from baseline score at the end of one month
Primary	Peak Ekspiratuar Flow	Peak Ekspiratuar Flow (PEF) measurement kind of test which can be accomplished through mobile hand-held tools that enable patients to follow their situations even at their own homes in asthma diagnose and treatment. Repeatability of the test is very high though its application is connected with effort. As PEF measurement gives information about big airways, lower values are obtained in comparison to FEV1 value at 30-50% of the patients. In PEF follow-up, the best PEF value of patient value is primarily defined. Because, the follow-up of patient is conducted in terms of his/her best value not in terms of prediction value indifferent to spirometer in PEF follow-up.	change from baseline score at the end of one month
Primary	Forced Expiratory Volume First Second	Forced expiratory volume in first second (FEV1), measured during breathing function test and a flow velocity, is the best indicator of obstruction in asthma. However, FEV1 reflects real obstruction only with powerful and maximum effort as it mostly related with effort.	change from baseline score at the end of one month
Primary	Forced Vital Capacity	Effort related part of forced vital capacity (FVC) reflects airways, pulmonary expriratory muscles and the situation of lung elastic recession power.	change from baseline score at the end of one month
Primary	FEV1/FVC	FEV1/FVC rate is an important final parameter in defining obstruction as there is not a great change observed in FVC values at early stages of the disease in most of the asthma patients.	change from baseline score at the end of one month