The efficacy of lifestyle changes based on the principles of yoga in the management of bronchial asthma

ISRCTN	ISRCTN00815962
DOI	https://doi.org/10.1186/ISRCTN00815962
Protocol serial number	N-581
Sponsor	Central Council for Research in Yoga & Naturopathy (CCRYN) (India)
Funder	Central Council for Research in Yoga & Naturopathy (CCRYN) (India)

Submission date: 08/10/2008
Registration date: 21/10/2008
Last edited: 04/08/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Kishore Kumar Deepak
Scientific

Department of Physiology
All India Institute of Medical Sciences
Ansari Nagar
New Delhi
110029
India

Phone	+91 (0)11 2659 3370
Email	kkdeepak@gmail.com

Study information

Primary study design	Interventional
Study design	Parallel-group randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Effect of yoga on pulmonary function, mast cell activation and quality of life in bronchial asthma: a randomised controlled trial
Study objectives	There are several studies suggesting that yoga has a favourable effect on the frequency and severity of attacks, pulmonary functions, dependence on medication and quality of life in bronchial asthma. Nevertheless, very few of the previous studies are randomised controlled trials (RCT), and none of them have investigated any immunological mechanisms by which yoga might work in bronchial asthma. Bronchial asthma is characterised by hyperreactivity of airways leading to airway obstruction, and is aggravated during stressful periods. Therefore yoga, which leads to improvement in respiratory function as well as stress reduction, is likely to be useful in the management of bronchial asthma.
Ethics approval(s)	The Ethics Committee of All India Institute of Medical Sciences (AIIMS) for human studies approved the original protocol of the study on 9th February 2001 and amendments were approved on 7th January 2004.
Health condition(s) or problem(s) studied	Bronchial asthma
Intervention	Group I (yoga group) was given an integrated course on lifestyle based on the principles of yoga for 2 weeks while continuing with the conventional treatment. At the end of the 2-week training, participants were asked to continue the practice at home for an additional 6 weeks. Parameters were recorded at regular intervals (0 weeks, 2 weeks, 4 weeks and 8 weeks). During the follow-up period, the patients were expected to continue the yoga practice daily. Their compliance was monitored by a diary, which they brought at each visit. Group II (control group) was a wait-listed control group. For the first 8 weeks, the patients in Group II did not receive any yogic intervention but they continued to receive conventional treatment. The parameters were recorded at regular intervals as in Group I. At the end of 8 weeks, the patients in Group II were also offered yoga intervention as for Group I, i.e. a two-week course. Parameters from both the groups are recorded at regular intervals at 0 weeks, 2 weeks, 4 weeks and 8 weeks, although the last timepoint for recording parameters was not equally separated, taking our patients convenience and continued compliance into consideration, we have kept 4 week separation for last study visit.
Intervention type	Other
Primary outcome measure(s)	1. Spirometric indices of pulmonary function 2. Eosinophilic cationic protein as a marker of the course of the disease 3. The degree of exercise-induced bronchoconstriction as percentage of fall in FEV1 with exercise challenge 4. Urinary concentration of the prostaglandin D2 metabolite, 11 beta-Prostaglandin F2a (11 beta-PGF2a), before and after the exercise challenge as a marker of mast cell activation Recorded at regular intervals at 0 weeks, 2 weeks, 4 weeks and 8 weeks.
Key secondary outcome measure(s)	1. Asthma quality of life: quality of life was measured by using a self-administered Asthma Quality of Life Questionnaire (AQLQ) which is available in bilingual form, i.e. English and Hindi (local Indian language) 2. Frequency of rescue medication Recorded at regular intervals at 0 weeks, 2 weeks, 4 weeks and 8 weeks.
Completion date	28/02/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	60
Key inclusion criteria	The potential subjects (adults of either sex) went through a step-wise screening procedure which consisted of satisfying the following criteria: 1. Clinical history of episodic airway obstruction 2. Forced expiratory volume of one second (FEV1), or peak expiratory flow rate (PEFR) less than 80 percent of predicted normal and more than 10% or at least 200 mL increase in FEV1 15 minutes after administration of two puffs of salbutamol 3. Presence of at least two clinical criteria of mild or moderate bronchial asthma for at least 6 months
Key exclusion criteria	1. Any respiratory tract infection during the past 4 weeks 2. On systemic or oral corticosteroid therapy 3. Smokers (any one who had smoked during the last one year was considered a smoker) 4. Concomitant major illness such as coronary heart disease, renal disease or diabetes 5. Practiced yoga or any other similar discipline during 6 months preceding the study
Date of first enrolment	19/04/2002
Date of final enrolment	28/02/2006

Locations

Countries of recruitment

India

Study participating centre

Department of Physiology

New Delhi
110029
India

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	30/07/2009		Yes	No
Abstract results		25/05/2007		No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes