Condition category
Respiratory
Date applied
08/10/2008
Date assigned
21/10/2008
Last edited
04/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Kishore Kumar Deepak

ORCID ID

Contact details

Department of Physiology
All India Institute of Medical Sciences
Ansari Nagar
New Delhi
110029
India
+91 (0)11 2659 3370
kkdeepak@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N-581

Study information

Scientific title

Effect of yoga on pulmonary function, mast cell activation and quality of life in bronchial asthma: a randomised controlled trial

Acronym

Study hypothesis

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

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.

Study design

Parallel-group randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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.

Secondary outcome measures

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.

Overall trial start date

19/04/2002

Overall trial end date

28/02/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant 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

Recruitment start date

19/04/2002

Recruitment end date

28/02/2006

Locations

Countries of recruitment

India

Trial participating centre

Department of Physiology
New Delhi
110029
India

Sponsor information

Organisation

Central Council for Research in Yoga & Naturopathy (CCRYN) (India)

Sponsor details

Department of Ayurveda
Yoga & Naturopathy
Unani
Siddha and Homeopathy
Ministry of Health and Family Welfare (Government of India)
Jawahar Lal Nehru Bhartiya Chikitsa Evam
Homeopathy Anusandhan Bhawan
61 - 65 Institutional Area
Janakpuri
Phankha Road
New Delhi
110058
India
+91 (0)11 2852 0430/0431/0432
ccryn@vsnl.net

Sponsor type

Research organisation

Website

http://www.ccryn.org

Funders

Funder type

Research organisation

Funder name

Central Council for Research in Yoga & Naturopathy (CCRYN) (India)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19643002

Abstracts published in Conferences & Workshops:
1. World Allergy Congress 2007: The use of yoga as an adjuvant therapy in the management of bronchial asthma: based on a randomized controlled trial. Vempati R, Deepak KK. World Allergy Organization Journal; WAC 2007: S153
2. European Academy of Allergology and Clinical Immunology Conference 2007: Effect of yogic practices on airway inflammation, mast cell activation and exercise induced asthma: a randomized controlled trial. R Vempati, K Deepak. Allergy 2007; 62 (Suppl 83): 217
3. World Allergy Congress 2005: Effect of yoga on exercise induced bronchoconstriction and urinary prostaglandin D2 metabolite in bronchial asthma. Vempati RP, Bijlani RL, Deepak KK (2005). Allergy Clin Immunol Int: Journal of World Allergy Organization, 2005 (1): 593
4. APPICON 2004: A Randomized controlled trial on the efficacy of yoga in the management of bronchial asthma. RP Vempati, S Manjunatha, RL Bijlani. Indian J Physiol Pharmacol 2004; 48 (5): 242-243
5. International Conference on Yoga & Its Applications (ICYA 2004): A controlled study on the efficacy of yoga in bronchial asthma. RP Vempati & RL Bijlani

Publication citations

  1. Results

    Vempati R, Bijlani RL, Deepak KK, The efficacy of a comprehensive lifestyle modification programme based on yoga in the management of bronchial asthma: a randomized controlled trial., BMC Pulm Med, 2009, 9, 37, doi: 10.1186/1471-2466-9-37.

Additional files

Editorial Notes