NCT04310696

Brief Summary

The objective of the study was to compare the effects of Buteyko breathing technique and pursed lip breathing technique in the management of asthma. A randomized controlled trial was conducted on 60 asthmatic patients randomly allocated to Buteyko technique group and pursed lip breathing group. Both the groups received 4 weeks of treatment, 3 times per week. Data was collected at base line, 2nd week and 4th week. Outcome measurements included FVC, FEV, PEFR and Asthma Control Test Questionnaire scores. Data analysis was carried out on Statistical Package for the Social Sciences (SPSS) v.21.0. Confidence interval was kept at 95% and a p-value of less than 0.05 was considered significant.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 17, 2020

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

6 months

First QC Date

March 6, 2020

Last Update Submit

March 12, 2020

Conditions

Keywords

AsthmaButeykoPursed lip breathingSpirometer

Outcome Measures

Primary Outcomes (5)

  • Peak expiratory flow rate (PEFR)

    Peak expiratory flow rate (PEFR) measured through digital spirometer. Peak Expiratory Flow Rate (PEFR) measured through digital spirometer. Three zones of measurement are commonly used to interpret peak flow rates. Normal value of PEFR is (80-100%). Green zone indicates 80 to 100 percent of the usual or normal peak flow reading, yellow zone indicates 50 to 79 percent of the usual or normal peak flow readings, and red zone indicates less than 50 percent of the usual or normal peak flow readings.

    After 4 weeks of intervention

  • Forced vital capacity (FVC)

    Forced vital capacity (FVC) measured through digital spirometer. If the value of FVC is within 80% of the reference value, the results are considered normal.

    After 4 weeks of intervention

  • Forced expiratory volume in 1sec (FEV1)

    Forced expiratory volume in 1sec (FEV1) measured through digital spirometer. If the value of FEV1 is within 80% of the reference value, the results are considered normal.

    After 4 weeks of intervention

  • FVC/FEV1

    FVC/FEV1 measured through digital spirometer. The normal value for the FEV1/FVC ratio is 70% (and 65% in persons older than age 65).

    After 4 weeks of intervention

  • Asthma Control Questionnaire

    Asthma Control questionnaire is a self-reported subjective outcome measurement tool that is used to measure the sufficiency of asthma symptom control and changes in asthma symptoms. It is 5 point scale with scores ranging from 0 to 5 for each item. The greater the score of Asthma Control questionnaire, the better the prognosis and outcome.

    After 4 weeks of intervention

Study Arms (2)

Buteyko group

EXPERIMENTAL

Buteyko breathing exercises

Other: Buteyko Breathing exercises

Pursed lip breathing

ACTIVE COMPARATOR

Pursed lip breathing exercises

Other: Pursed lip breathing

Interventions

Buteyko breathing technique was performed by asking the patient to take a small breath in and then out and hold his/her breath and count the time in seconds, as long as he or she can, until first signs of air hunger start to appear, followed by normal breathing once again. This procedure was repeated 15 times, three sets of 15 repetitions were given to the patient per day, 3 days per week and the treatment was continued for 4 weeks.

Buteyko group

Pursed lip breathing was performed as nasal inspiration followed by expiratory blowing against partially closed lips. Participants received a total of 3 sets of 15 repetitions per day, 3 times a week and the treatment was continued for 4 weeks.

Pursed lip breathing

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients categorized as mild to moderate persistent asthma category according to the "National Asthma Education and Prevention Program"

You may not qualify if:

  • Use of oral steroids within the four-week run-in period,
  • Change in inhaled steroid dose and type,
  • Other significant unstable medical conditions,
  • They have undertaken Buteyko breathing technique previously.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (8)

  • Davies SJ, Jackson PR, Ramsay LE. Dysfunctional breathing and asthma. Panic disorder needs to be considered. BMJ. 2001 Sep 15;323(7313):631; author reply 631-2. No abstract available.

    PMID: 11575318BACKGROUND
  • Stoodley I, Williams L, Thompson C, Scott H, Wood L. Evidence for lifestyle interventions in asthma. Breathe (Sheff). 2019 Jun;15(2):e50-e61. doi: 10.1183/20734735.0019-2019.

    PMID: 31777565BACKGROUND
  • Arden-Close EJ, Kirby SE, Yardley L, Bruton A, Ainsworth B, Thomas DM. Evaluation of a breathing retraining intervention to improve quality of life in asthma: quantitative process analysis of the BREATHE randomized controlled trial. Clin Rehabil. 2019 Jul;33(7):1139-1149. doi: 10.1177/0269215519832942. Epub 2019 Feb 27.

    PMID: 30813767BACKGROUND
  • Singh V, Wisniewski A, Britton J, Tattersfield A. Effect of yoga breathing exercises (pranayama) on airway reactivity in subjects with asthma. Lancet. 1990 Jun 9;335(8702):1381-3. doi: 10.1016/0140-6736(90)91254-8.

    PMID: 1971670BACKGROUND
  • Zampogna E, Centis R, Negri S, Fiore E, Cherubino F, Pignatti P, Heffler E, Canonica GW, Sotgiu G, Saderi L, Migliori GB, Spanevello A, Visca D. Effectiveness of pulmonary rehabilitation in severe asthma: a retrospective data analysis. J Asthma. 2020 Dec;57(12):1365-1371. doi: 10.1080/02770903.2019.1646271. Epub 2019 Aug 13.

    PMID: 31317799BACKGROUND
  • Austin G. Buteyko technique use to control asthma symptoms. Nurs Times. 2013 Apr 24-30;109(16):16-7.

    PMID: 23697004BACKGROUND
  • Barker NJ, Jones M, O'Connell NE, Everard ML. Breathing exercises for dysfunctional breathing/hyperventilation syndrome in children. Cochrane Database Syst Rev. 2013 Dec 18;2013(12):CD010376. doi: 10.1002/14651858.CD010376.pub2.

    PMID: 24347088BACKGROUND
  • Wang Q, Zhang W, Liu L, Yang W, Liu H. Effects of physical therapy on lung function in children with asthma: Study protocol for a systematic review and meta-analysis. Medicine (Baltimore). 2019 Apr;98(15):e15226. doi: 10.1097/MD.0000000000015226.

    PMID: 30985726BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Suman Sheraz, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2020

First Posted

March 17, 2020

Study Start

August 30, 2018

Primary Completion

February 15, 2019

Study Completion

August 20, 2019

Last Updated

March 17, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations