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Completed

NCT Number: NCT04110951

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nevşehir Haci Bektaş Veli Üniversitesi

Nevşehir, Nerkez, 50000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pranayama Breathing Technique

Behavioral

Yogic Breathing Technique

relaxation technique

Behavioral

Progressive relaxation technique

Primary outcomes

  1. Asthma Control Test

    Time frame: change from baseline score at the end of one month

    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

  2. Asthma Quality of Life Questionnaire

    Time frame: change from baseline score at the end of one month

    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" .

  3. Peak Ekspiratuar Flow

    Time frame: change from baseline score at the end of one month

    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.

  4. Forced Expiratory Volume First Second

    Time frame: change from baseline score at the end of one month

    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.

  5. Forced Vital Capacity

    Time frame: change from baseline score at the end of one month

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

  6. FEV1/FVC

    Time frame: change from baseline score at the end of one month

    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.

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Oct 1, 2019
Registry last updated
Oct 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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