COPDNCT05947253
Comparative Effects of BBT and Active Cycle of Breathing Technique on Dyspnea and Quality of Life in COPD
A study testing Buyteko breathing technique and active cycle of breathing technique in people with COPD, run by Riphah International University at 1 site in Pakistan.
Trial summary
Comparative effects of Butyeko breathing technique and Active Cycle of Breathing technique on dyspnea and quality of life in patients with chronic obstructive pulmonary disease Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- COPD
- What is being tested?
- Buyteko breathing technique and active cycle of breathing technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 15 May 2023to 15 Dec 2023
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of COPD confirmed by smoking history.
- PFT showing irreversible airflow limitation.
- Patients hemodynamically stable.
- Males and females.
- Patients capable of completing IPAQ questionnaire
Who cannot join
- Evidence of unstable cardiac disease, Pulmonale decompensation
- Disabling diseases which prevented participation in the exercise program, such as orthopedic inabilities or peripheral vascular disease.
- Systemic illness.
- Resting O2 saturation <90% with room air breathing and Patient with viral infection
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Pulmonary ward Jinnah hospital Lahore.
Lahore, Punjab Province, 54000
Sidra Faisal, MS.CPPT, 03022001847, sidra.faisal@riphah.edu.pk
Bilal Baig, DPT
About this study
Comparative effects of Butyeko breathing technique and Active Cycle of Breathing technique on dyspnea and quality of life in patients with chronic obstructive pulmonary disease
Read the detailed description
A comparative study to determine the effects of butyeko breathing techniques and Active Cycle of Breathing technique on dyspnea and quality of life in patients with chronic obstructive pulmonary disease. As few researches on Butyeko breathing techniques are still present on COPD most of them are on asthma. The goal of the Butyeko Method is to improve breathing patterns, as indicated by achieving a higher breath hold time (control pause). Every five seconds improvement to the control pause, results in an alleviation of breathing difficulty and improved control of COPD The Butyeko method is a purported method of "retraining" the body's breathing pattern to correct for the presumed chronic hyperventilation and hypocapnea, and thereby treat or cure the body of these medical problems. Patients with chronic obstructive pulmonary disease (COPD) often suffer from expectoration. To address this problem, active cycle of breathing techniques (ACBT) can be applied in patients of COPD. In our study daily Butyeko breathing exercise and active cycle of breathing technique session of 30 to 35 minutes will be given to patients and effects of both techniques will be compared.
A randomized clinical trial will be conducted using convenient sampling or randomized sampling technique in population of chronic obstructive pulmonary disease (COPD).Total sample size will be of 40 and two Groups will be made Group A 20 participants received Buyteko breathing technique and Groups B 20 participants received Active cycle of breathing technique. Data will be collected by using Borg's dyspnea scale, St.George Respiratory questionnaire and by pulmonary function testing. Data will be collected from pulmonary ward Jinnah hospital Lahore whole study will take total duration of 10 months and data will be analyzed using latest version of SPSS-25 software.
- Conditions
- COPD
- Being tested
- Buyteko breathing technique, active cycle of breathing technique
- Keywords
- Buteyko breathing technique
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buyteko breathing techniqueOther
group A 20 participants received Buyteko breathing technique 2 session for 3 weeks
active cycle of breathing techniqueOther
Group B 20 participants received active cycle of breathing technique 2 session for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| BUTYEKO BREATHING TECHNIQUE | Experimental | First Group A 20 participants received Buyteko breathing technique while will be given 5 days per week Receives: Other: Buyteko breathing technique |
| active cycle of breathing technique | Experimental | Group B 20 participants received active cycle of breathing technique and session of 35min will be given 5 days per week Receives: Other: active cycle of breathing technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Borg's dyspnea scale.
For the measurement of dyspnea The Modified Borg Dyspnea Scale (MBS) is a 0 to 10 rated numerical score used to measure dyspnea as reported by the patient during submaximal exercise and is routinely administered during six-minute walk testing (6MWT
Measured: 4 weeks
Spirometry
Spirometry is the most common of the pulmonary function tests. It measures lung function, specifically the amount and/or speed of air that can be inhaled and exhaled.
Spirometry is helpful in assessing breathing patterns that identify conditions such as asthma, Chronic obstructive pulmonary disease
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start15 May 2023
- Primary completion10 Oct 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- 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
- Model description
- make 2 groups Patients who will meet the inclusion criteria will be recruited by convenient sampling technique and allocated in two groups by simple randomization process. First Group A 20 participants received Buyteko breathing technique while Group B 20 participants received active cycle of breathing technique and session of 35min will be given 5 days per week and data will be collected by using St. George's respiratory questionnaire for determining the quality of life and Borg's dyspnea scale for measuring breathlessness.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sidra Faisal, MS.CPPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05947253
- Sponsor's protocol ID
- REC/RCR & AHS/22/0318
- Status last verified
- Jul 2023
- First submitted
- 14 Jun 2023
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vogelmeier CF, Roman-Rodriguez M, Singh D, Han MK, Rodriguez-Roisin R, Ferguson GT. Goals of COPD treatment: Focus on symptoms and exacerbations. Respir Med. 2020 May;166:105938. doi: 10.1016/j.rmed.2020.105938. Epub 2020 Mar 21.
PubMed 32250871May SM, Li JT. Burden of chronic obstructive pulmonary disease: healthcare costs and beyond. Allergy Asthma Proc. 2015 Jan-Feb;36(1):4-10. doi: 10.2500/aap.2015.36.3812.
PubMed 25562549Halpin DM, Miravitlles M. Chronic obstructive pulmonary disease: the disease and its burden to society. Proc Am Thorac Soc. 2006 Sep;3(7):619-23. doi: 10.1513/pats.200603-093SS.
PubMed 16963544Fazleen A, Wilkinson T. Early COPD: current evidence for diagnosis and management. Ther Adv Respir Dis. 2020 Jan-Dec;14:1753466620942128. doi: 10.1177/1753466620942128.
PubMed 32664818Smith MC, Wrobel JP. Epidemiology and clinical impact of major comorbidities in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2014 Aug 27;9:871-88. doi: 10.2147/COPD.S49621. eCollection 2014.
PubMed 25210449Lopez AD, Shibuya K, Rao C, Mathers CD, Hansell AL, Held LS, Schmid V, Buist S. Chronic obstructive pulmonary disease: current burden and future projections. Eur Respir J. 2006 Feb;27(2):397-412. doi: 10.1183/09031936.06.00025805. No abstract available.
PubMed 16452599
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of BBT and Active Cycle of Breathing Technique on Dyspnea and Quality of Life in COPD
- ClinicalTrials.gov ID
- NCT05947253
- Acronym / sponsor ID
- REC/RCR & AHS/22/0318
- Conditions
- COPD
- Keywords
- Buteyko breathing technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 10 Oct 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 17 Jul 2023 (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.
Comparative effects of Butyeko breathing technique and Active Cycle of Breathing technique on dyspnea and quality of life in patients with chronic obstructive pulmonary disease
Detailed description
A comparative study to determine the effects of butyeko breathing techniques and Active Cycle of Breathing technique on dyspnea and quality of life in patients with chronic obstructive pulmonary disease. As few researches on Butyeko breathing techniques are still present on COPD most of them are on asthma. The goal of the Butyeko Method is to improve breathing patterns, as indicated by achieving a higher breath hold time (control pause). Every five seconds improvement to the control pause, results in an alleviation of breathing difficulty and improved control of COPD The Butyeko method is a purported method of "retraining" the body's breathing pattern to correct for the presumed chronic hyperventilation and hypocapnea, and thereby treat or cure the body of these medical problems. Patients with chronic obstructive pulmonary disease (COPD) often suffer from expectoration. To address this problem, active cycle of breathing techniques (ACBT) can be applied in patients of COPD. In our study daily Butyeko breathing exercise and active cycle of breathing technique session of 30 to 35 minutes will be given to patients and effects of both techniques will be compared.
A randomized clinical trial will be conducted using convenient sampling or randomized sampling technique in population of chronic obstructive pulmonary disease (COPD).Total sample size will be of 40 and two Groups will be made Group A 20 participants received Buyteko breathing technique and Groups B 20 participants received Active cycle of breathing technique. Data will be collected by using Borg's dyspnea scale, St.George Respiratory questionnaire and by pulmonary function testing. Data will be collected from pulmonary ward Jinnah hospital Lahore whole study will take total duration of 10 months and data will be analyzed using latest version of SPSS-25 software.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- make 2 groups Patients who will meet the inclusion criteria will be recruited by convenient sampling technique and allocated in two groups by simple randomization process. First Group A 20 participants received Buyteko breathing technique while Group B 20 participants received active cycle of breathing technique and session of 35min will be given 5 days per week and data will be collected by using St. George's respiratory questionnaire for determining the quality of life and Borg's dyspnea scale for measuring breathlessness.
| Arm | Type | Receives |
|---|---|---|
| BUTYEKO BREATHING TECHNIQUE | Experimental | Other: Buyteko breathing techniqueFirst Group A 20 participants received Buyteko breathing technique while will be given 5 days per week |
| active cycle of breathing technique | Experimental | Other: active cycle of breathing techniqueGroup B 20 participants received active cycle of breathing technique and session of 35min will be given 5 days per week |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of COPD confirmed by smoking history.
- PFT showing irreversible airflow limitation.
- Patients hemodynamically stable.
- Males and females.
- Patients capable of completing IPAQ questionnaire
Key exclusion criteria (4 listed)
- Evidence of unstable cardiac disease, Pulmonale decompensation
- Disabling diseases which prevented participation in the exercise program, such as orthopedic inabilities or peripheral vascular disease.
- Systemic illness.
- Resting O2 saturation <90% with room air breathing and Patient with viral infection
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 |
|---|---|---|
| Buyteko breathing techniquegroup A 20 participants received Buyteko breathing technique 2 session for 3 weeks | Other | BUTYEKO BREATHING TECHNIQUE |
| active cycle of breathing techniqueGroup B 20 participants received active cycle of breathing technique 2 session for 3 weeks | Other | active cycle of breathing technique |
Primary outcome
Borg's dyspnea scale.
Time frame: 4 weeks
For the measurement of dyspnea The Modified Borg Dyspnea Scale (MBS) is a 0 to 10 rated numerical score used to measure dyspnea as reported by the patient during submaximal exercise and is routinely administered during six-minute walk testing (6MWT
Spirometry
Time frame: 4 weeks
Spirometry is the most common of the pulmonary function tests. It measures lung function, specifically the amount and/or speed of air that can be inhaled and exhaled. Spirometry is helpful in assessing breathing patterns that identify conditions such as asthma, Chronic obstructive pulmonary disease
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- Background: PubMed 32250871Vogelmeier CF, Roman-Rodriguez M, Singh D, Han MK, Rodriguez-Roisin R, Ferguson GT. Goals of COPD treatment: Focus on symptoms and exacerbations. Respir Med. 2020 May;166:105938. doi: 10.1016/j.rmed.2020.105938. Epub 2020 Mar 21.
- Background: PubMed 25562549May SM, Li JT. Burden of chronic obstructive pulmonary disease: healthcare costs and beyond. Allergy Asthma Proc. 2015 Jan-Feb;36(1):4-10. doi: 10.2500/aap.2015.36.3812.
- Background: PubMed 16963544Halpin DM, Miravitlles M. Chronic obstructive pulmonary disease: the disease and its burden to society. Proc Am Thorac Soc. 2006 Sep;3(7):619-23. doi: 10.1513/pats.200603-093SS.
- Background: PubMed 32664818Fazleen A, Wilkinson T. Early COPD: current evidence for diagnosis and management. Ther Adv Respir Dis. 2020 Jan-Dec;14:1753466620942128. doi: 10.1177/1753466620942128.
- Background: PubMed 25210449Smith MC, Wrobel JP. Epidemiology and clinical impact of major comorbidities in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2014 Aug 27;9:871-88. doi: 10.2147/COPD.S49621. eCollection 2014.
- Background: PubMed 16452599Lopez AD, Shibuya K, Rao C, Mathers CD, Hansell AL, Held LS, Schmid V, Buist S. Chronic obstructive pulmonary disease: current burden and future projections. Eur Respir J. 2006 Feb;27(2):397-412. doi: 10.1183/09031936.06.00025805. No abstract available.
- 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.
Sidra Faisal, MS.CPPT 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 Buyteko breathing technique and active cycle of breathing technique in people with COPD, 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 5 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: status not confirmed, as of the sponsor's last update on 17 Jul 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Iqbal Tariq, PHD (O3338236752, iqbal.tariq@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Borg's dyspnea scale. (time frame: 4 weeks). The study lists 2 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 NCT05947253, which also lists 6 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 Jul 2023.