The Effect of Pranayama Breathing Technique on Asthma Control, Pulmonary Function and Quality of Life: A Single-Blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Forced Expiratory Volume First Second
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •To have lung diseases such as COPD,
- •To have tuberculosis and respiratory infection,
- •To have diabetes and coronary artery disease,
- •Pregnant or nursing mother,
- •Doing regular exercise,
- •Benefitng from other complementary and integrative health applications during treatments
研究组 & 干预措施
Pranayama group
Kapalbhati, 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.
干预措施: Pranayama Breathing Technique (Behavioral)
Relaxation group
As 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.
干预措施: Relaxation technique (Behavioral)
结局指标
主要结局
Forced Expiratory Volume First Second
时间窗: 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.
FEV1/FVC
时间窗: 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.
Asthma Control Test
时间窗: 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
Forced Vital Capacity
时间窗: 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.
Asthma Quality of Life Questionnaire
时间窗: 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" .
Peak Ekspiratuar Flow
时间窗: 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.
次要结局
未报告次要终点
研究者
Gülyeter Erdoğan Yüce
Principal Investigator
TC Erciyes University