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AsthmaNCT04110951

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

A study testing Pranayama Breathing Technique and Relaxation technique in people with Asthma, run by TC Erciyes University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Asthma
What is being tested?
Pranayama Breathing Technique and Relaxation technique
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Feb 2018to 17 May 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Nevşehir Haci Bektaş Veli Üniversitesi

    Nevşehir, Nerkez, 50000

Other trials in Turkey (Türkiye)

About this study

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

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.

Conditions
Asthma
Being tested
Pranayama Breathing Technique, Relaxation technique
Keywords
Asthma, Yoga, Breathing exercises, Quality of life, Nursing
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pranayama Breathing TechniqueBehavioural

    Yogic Breathing Technique

  • Relaxation techniqueBehavioural

    Progressive relaxation technique

Study groups in NCT04110951
Study groupRoleWhat they receive
Pranayama groupExperimentalKapalbhati, Ujjayi and Anuloma-Viloma pranayama techniques were applied to the experimental group. Within this scope, a three days of applied training program was prepared and a guide involving the steps of Pranayama breathing technique was formed. The patients in of pranayama group were trained by the researcher who had yoga trainer certificate. After completing three days of training and observations regarding their accomplishment of applications properly, a pranayama breathing technique video showing how the pranayama breathing technique is done with its details was downloaded to their smartphones and a guide including the application steps was distributed to the patients. The patients were required to apply pranayama technique, in company with the video, 20 min every day and a month in total.
Receives: Behavioral: Pranayama Breathing Technique
Relaxation groupActive comparatorAs there was not placebo breathing control treatment appropriate to yoga breathing technique, relaxation technique was decided to apply in the second group to equalize psychological effects of the treatment. Progressive relaxation technique was taught to the relaxation group during the same training span.A three days of applied training program and Relaxation Technique Application Guide, including steps of progressive relaxation technique, were prepared within this scope. After completing three days of training and observations regarding their accomplishment of applications properly, a relaxing music to listen during applications and a training video involving progressive relaxation directives were downloaded to smartphones of the patients. Also, Relaxation Technique Application Guide involving application steps were distributed to the patients. The patients were required to apply relaxation technique, in company with the video, 20 min every day and a month in total.
Receives: Behavioral: Relaxation technique

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: change from baseline score at the end of one month

  2. 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" .

    Measured: change from baseline score at the end of one month

  3. 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.

    Measured: change from baseline score at the end of one month

  4. 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.

    Measured: change from baseline score at the end of one month

  5. Forced Vital Capacity

    Effort related part of forced vital capacity (FVC) reflects airways, pulmonary expriratory muscles and the situation of lung elastic recession power.

    Measured: change from baseline score at the end of one month

  6. 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.

    Measured: change from baseline score at the end of one month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2019
  2. Study start1 Feb 2018
  3. Primary completion25 Dec 2018
  4. Study completion17 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04110951
Sponsor's protocol ID
TDK-2017-7652
Status last verified
Sep 2019
First submitted
27 Sep 2019
Last updated
1 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There are no plans.

Publications

  • Agarwal D, Gupta PP, Sood S. Assessment for Efficacy of Additional Breathing Exercises Over Improvement in Health Impairment Due to Asthma Assessed using St. George's Respiratory Questionnaire. Int J Yoga. 2017 Sep-Dec;10(3):145-151. doi: 10.4103/0973-6131.213472.

    PubMed 29422745
  • 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.

    PubMed 29861589
  • 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. doi: 10.1136/thorax.58.8.674.

    PubMed 12885982
  • 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.

    PubMed 18249107
  • Fluge 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.

    PubMed 7937658
  • 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.

    PubMed 23465447
  • 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. doi: 10.1136/thx.2006.076430. Epub 2007 Jun 15.

    PubMed 17573445
  • Husseın NA, Afıfy 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. doi: 10.1016/j.mehy.2006.02.042. Epub 2006 Apr 18.

    PubMed 16624497
  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing Pranayama Breathing Technique and Relaxation technique in people with Asthma, run by TC Erciyes University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Asthma Control Test (time frame: change from baseline score at the end of one month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04110951, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2019.

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