AsthmaNCT04310696
Comparison of Buteyko Technique and Pursed Lip Breathing in Asthma
A study testing Buteyko Breathing exercises and Pursed lip breathing in people with Asthma, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Asthma
- What is being tested?
- Buteyko Breathing exercises and Pursed lip breathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Aug 2018to 20 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients categorized as mild to moderate persistent asthma category according to the "National Asthma Education and Prevention Program"
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Buteyko Breathing Technique and Pursed Lip Breathing to Improve Pulmonary Function in Asthma
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.
Read the detailed description
Asthma is an inflammatory condition in which narrowing and swelling of the airways occur, accompanied with extra mucus production. This results in difficulty in breathing and triggers coughing, wheezing and dyspnea. In some cases asthma is a minor irritation, but on the other end of the spectrum it may interfered with activities of daily living and can even become life threatening in severe asthma attacks. According to a study conducted in Pakistan, the prevalence of asthma in adults was found to be 10.8% in adults, working in tanneries with 5.3% of them reporting their symptoms to be work related.
Non-pharmacological management of asthma includes patient education, guidance and physiotherapy. It is suggested that physical therapy may have positive effects in patients with asthma, as they possess dysfunctional breathing patterns accompanied with poor physical condition. Numerous reviews by Cochrane have been published in the recent years regarding the effects of physical therapy in patients with asthma, focusing on the effects of numerous techniques including Alexander technique, manual therapy, physical training, breathing exercises and inspiratory muscle training. In terms of specific effects of different physical therapy treatment techniques in patients with asthma, in light of the existing literature, breathing exercises have found to improve quality of life, reduce symptoms of anxiety, depression and hyperventilation, and decrease respiratory rate and medication use. Moreover, inspiratory muscle training is found to improve symptoms, decrease medication use and also improve inspiratory pressure.
Buteyko technique is a specialized breathing technique developed to reduce chronic hyperinflation.
A pre and post design quasi experimental study conducted was conducted in 2014 to determine the effects of Buteyko breathing technique on asthma control and QOL in school aged children with asthma where Buteyko breathing technique group showed significant improvements terms of asthma control and quality of life.
Based upon the review of the literature, evidence is inadequate in terms of comparison of Buteyko breathing technique with pursed lip breathing technique in the management of patients with asthma except for a single randomized controlled trial. For this reason the purpose of the current study is to compare the effects of Buteyko technique with pursed lip breathing in the management of patients with asthma.
- Conditions
- Asthma
- Being tested
- Buteyko Breathing exercises, Pursed lip breathing
- Keywords
- Asthma, Buteyko, Pursed lip breathing, Spirometer
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buteyko Breathing exercisesOther
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.
Pursed lip breathingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Buteyko group | Experimental | Buteyko breathing exercises Receives: Other: Buteyko Breathing exercises |
| Pursed lip breathing | Active comparator | Pursed lip breathing exercises Receives: Other: Pursed lip breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: After 4 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start30 Aug 2018
- Primary completion15 Feb 2019
- Study completion20 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suman Sheraz, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310696
- Sponsor's protocol ID
- REC/00424 Iqra Arshad Butt
- Status last verified
- Mar 2020
- First submitted
- 6 Mar 2020
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11575318Stoodley 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.
PubMed 31777565Arden-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.
PubMed 30813767Singh 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.
PubMed 1971670Zampogna 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.
PubMed 31317799Austin G. Buteyko technique use to control asthma symptoms. Nurs Times. 2013 Apr 24-30;109(16):16-7.
PubMed 23697004Barker 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.
PubMed 24347088Wang 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.
PubMed 30985726
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Buteyko Breathing Technique and Pursed Lip Breathing to Improve Pulmonary Function in Asthma
- ClinicalTrials.gov ID
- NCT04310696
- Acronym / sponsor ID
- REC/00424 Iqra Arshad Butt
- Conditions
- Asthma
- Keywords
- Asthma, Buteyko, Pursed lip breathing, Spirometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Aug 2018 (actual)
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 20 Aug 2019 (actual)
- First posted
- 17 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Asthma is an inflammatory condition in which narrowing and swelling of the airways occur, accompanied with extra mucus production. This results in difficulty in breathing and triggers coughing, wheezing and dyspnea. In some cases asthma is a minor irritation, but on the other end of the spectrum it may interfered with activities of daily living and can even become life threatening in severe asthma attacks. According to a study conducted in Pakistan, the prevalence of asthma in adults was found to be 10.8% in adults, working in tanneries with 5.3% of them reporting their symptoms to be work related.
Non-pharmacological management of asthma includes patient education, guidance and physiotherapy. It is suggested that physical therapy may have positive effects in patients with asthma, as they possess dysfunctional breathing patterns accompanied with poor physical condition. Numerous reviews by Cochrane have been published in the recent years regarding the effects of physical therapy in patients with asthma, focusing on the effects of numerous techniques including Alexander technique, manual therapy, physical training, breathing exercises and inspiratory muscle training. In terms of specific effects of different physical therapy treatment techniques in patients with asthma, in light of the existing literature, breathing exercises have found to improve quality of life, reduce symptoms of anxiety, depression and hyperventilation, and decrease respiratory rate and medication use. Moreover, inspiratory muscle training is found to improve symptoms, decrease medication use and also improve inspiratory pressure.
Buteyko technique is a specialized breathing technique developed to reduce chronic hyperinflation.
A pre and post design quasi experimental study conducted was conducted in 2014 to determine the effects of Buteyko breathing technique on asthma control and QOL in school aged children with asthma where Buteyko breathing technique group showed significant improvements terms of asthma control and quality of life.
Based upon the review of the literature, evidence is inadequate in terms of comparison of Buteyko breathing technique with pursed lip breathing technique in the management of patients with asthma except for a single randomized controlled trial. For this reason the purpose of the current study is to compare the effects of Buteyko technique with pursed lip breathing in the management of patients with asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buteyko group | Experimental | Other: Buteyko Breathing exercisesButeyko breathing exercises |
| Pursed lip breathing | Active comparator | Other: Pursed lip breathingPursed lip breathing exercises |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients categorized as mild to moderate persistent asthma category according to the "National Asthma Education and Prevention Program"
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buteyko Breathing exercisesButeyko 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. | Other | Buteyko group |
| Pursed lip breathingPursed 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. | Other | Pursed lip breathing |
Primary outcome
Peak expiratory flow rate (PEFR)
Time frame: After 4 weeks of intervention
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.
Forced vital capacity (FVC)
Time frame: After 4 weeks of intervention
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.
Forced expiratory volume in 1sec (FEV1)
Time frame: After 4 weeks of intervention
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.
FVC/FEV1
Time frame: After 4 weeks of intervention
FVC/FEV1 measured through digital spirometer. The normal value for the FEV1/FVC ratio is 70% (and 65% in persons older than age 65).
Asthma Control Questionnaire
Time frame: After 4 weeks of intervention
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Background: PubMed 11575318Davies 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.
- Background: PubMed 31777565Stoodley 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.
- Background: PubMed 30813767Arden-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.
- Background: PubMed 1971670Singh 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.
- Background: PubMed 31317799Zampogna 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.
- Background: PubMed 23697004Austin G. Buteyko technique use to control asthma symptoms. Nurs Times. 2013 Apr 24-30;109(16):16-7.
- Background: PubMed 24347088Barker 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.
- Background: PubMed 30985726Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suman Sheraz, PhD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buteyko Breathing exercises and Pursed lip breathing in people with Asthma, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak expiratory flow rate (PEFR) (time frame: After 4 weeks of intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04310696, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.