AsthmaNCT05931952
Comparative Effects Of Buteyko Breathing Techniques And Papworth Method In Asthmatic Patients
A study testing Buteyko breathing technique and Papworth method in people with Asthma, run by Riphah International University at 1 site in Pakistan.
Trial summary
Asthma is an inflammatory condition which is characterized by coughing, sneezing, and shortness of breath. The ratio of asthma is increasing day by day around the globe. According to an estimate, more than 300 million people are affected from this chronic respiratory disorder throughout the world. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Buteyko breathing technique and Papworth method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jun 2023to 5 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnosed asthmatic patients
- Age group 20-60 years
- Both genders
- Lung function (FEV predicted < 80% \& FEV1/FVC < 75%)
- Nighttime awakening 3-4 times/month
- Symptoms > 2 days/week
Who cannot join
- Unstable asthmatic patients
- Acute upper respiratory infection
- History of radiation
- Taking any oral steroid, mental disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects Of Buteyko Breathing Techniques And Papworth Method On Pulmonary Functions And Oxygen Saturation In Asthmatic Patients
Asthma is an inflammatory condition which is characterized by coughing, sneezing, and shortness of breath. The ratio of asthma is increasing day by day around the globe. According to an estimate, more than 300 million people are affected from this chronic respiratory disorder throughout the world. The asthma is diagnosis on basis of sign and symptoms as there is no gold standard of evaluating the asthma. There are basically two treatment strategies for asthma involving medical management and physiotherapy treatment. In medical treatment, steroid drugs and bronchodilators are given to asthmatic patients. Now a day, the physiotherapy treatment has gained much importance. There are numerous physiotherapy approaches available for rehabilitating asthma patients such as breathing techniques, yoga, and relaxation exercises. Buteyko technique includes three steps (control pause, shallow breathing and combination of step 1 \& 2). While, papworth method includes five steps (breathing, education, relaxation, combination of breathing and relaxation exercise and home exercises). The randomized clinical trials will be conducted for this study and data will be calculated using simple random sampling technique. The study will be carried out in Clinical Private (Farooq Clinic) setting Khushab and THQ Khushab for a period of 10 months after approval from research and ethical committee. Firstly, consent will be taken from the study participants. Screening will be done using WHO Quality of Life Scale questionnaire and asthma control test adult scores. Lung spirometry values (FVC, FEV1, \& FEV1/FVC) and oxygen saturation will be evaluated at baseline, 2 weeks, and 4 weeks. Patients will be divided into two groups. Group A \& Group B. Buteyko breathing technique will be performed to Group A patients and papworth method will be performed to Group B. Chest physiotherapy will be performed to both groups as a conservative treatment at baseline, 2 weeks, and 4weeks
- Conditions
- Asthma
- Being tested
- Buteyko breathing technique, Papworth method
- Keywords
- asthma,, breathing exercises, humans, oxygen saturation,, patients
- 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 techniqueOther
Group A: Buteyko breathing technique and conventional (chest physiotherapy) treatment for 5 times a week for about 20 minutes in one session for a period of 4 weeks. There are three steps involved in buteyko breathing technique.
Step 1; control pause breathing test (patient is asked to sit in an upright position and take normal breath. After this, asked the patient to take small breath-in for 2s and out for 3s. Control pause phase should not exceed for >30 seconds).
Step 2; maximum pause or shallow breathing (patient is asked to place fingers under the nose to monitor inflow of air. 2 or 3 flickers of air is taken in and exhale as slowly as possible).
Step 3; combine step 1 and 2. Bronchial drainage will be performed as a conventional treatment for 2 to 3 minutes in each segment. During that time, patient is asked to take deep and slow breaths followed by cough to help in clearing mucus.
Papworth methodOther
Papworth method and conventional chest physiotherapy (bronchial drainage) treatment. Intervention will be given for a period of 5 sessions per week for 1 month. Duration of each session will be 20 minutes. This technique is performed particularly during remission period that make it feasible for respiratory physiotherapist to integrate this method into activities of daily living. Papworth method has five components including Papworth method ameliorates asthmatic symptoms breathing, education, relaxation, combination of breathing and relaxation exercise and home exercises and also improves quality of life.
Bronchial drainage will be performed as a conventional treatment for 2 to 3 minutes in each segment. During that time, patient is asked to take deep and slow breaths followed by cough to help in clearing mucus.
| Study group | Role | What they receive |
|---|---|---|
| Buteyko breathing technique | Experimental | Buteyko breathing technique and conventional (chest physiotherapy) treatment for 5 times a week for about 20 minutes in one session for a period of 4 weeks. There are three steps involved in buteyko breathing technique.
Step 1; control pause breathing test (patient is asked to sit in an upright position and take normal breath. After this, asked the patient to take small breath-in for 2s and out for 3s. Control pause phase should not exceed for >30 seconds).
Step 2; maximum pause or shallow breathing (patient is asked to place fingers under the nose to monitor inflow of air. 2 or 3 flickers of air is taken in and exhale as slowly as possible).
Step 3; combine step 1 and 2. Bronchial drainage will be performed as a conventional treatment for 2 to 3 minutes in each segment. During that time, patient is asked to take deep and slow breaths followed by cough to help in clearing mucus. Receives: Other: Buteyko breathing technique |
| Papworth method | Experimental | Papworth method and conventional chest physiotherapy (bronchial drainage) treatment. Intervention will be given for a period of 5 sessions per week for 1 month. Duration of each session will be 20 minutes. This technique is performed particularly during remission period that make it feasible for respiratory physiotherapist to integrate this method into activities of daily living. Papworth method has five components including Papworth method ameliorates asthmatic symptoms breathing, education, relaxation, combination of breathing and relaxation exercise and home exercises and also improves quality of life.
Bronchial drainage will be performed as a conventional treatment for 2 to 3 minutes in each segment. During that time, patient is asked to take deep and slow breaths followed by cough to help in clearing mucus. Receives: Other: Papworth method |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFT to assess change
It is the Pulmonary Function Test and these tests are used to measure lungs functions. These are specifically necessary for diagnosis of respiratory diseases. The data calculated from PFT include Force Vital Capacity (FVC), Force Expiratory Volume at 1 second (FEV1), and FEV1/FVC
Measured: baseline and fourth week
Asthma Control Test Adult (ACT) to assess change
Asthma Control Test (ACT) is a clinical tool for evaluation of symptoms of asthmatic patients. It is a 5-item questionnaire for the assessment of patient-reported asthma control. The study has illustrated that this tool has content validity
Measured: baseline and fourth week
WHOQOL to assess change
This questionnaire was represented by the WHO (World Health Organization) and it is used to assess quality and wellbeing of an individual. The study has elaborated the validity and reliability of this tool. Low score on this scale indicates depression and anxiety like symptoms
Measured: baseline and fourth week
Oximeter to assess change
It is an instrument which is used to evaluate oxygen level of blood. This test is performed in various lungs and heart diseases. It is a painless and non-invasive procedure of measuring oxygen saturation. It simply works by placing the device on finger
Measured: baseline and fourth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start15 Jun 2023
- Primary completion15 Sep 2023
- Study completion5 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sidra Afzal, PP-DPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931952
- Sponsor's protocol ID
- REC/RCR&AHS/23/0319
- Status last verified
- Dec 2023
- First submitted
- 6 Jun 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Andreasson KH, Skou ST, Ulrik CS, Madsen H, Sidenius K, Assing KD, Porsbjerg C, Bloch-Nielsen J, Thomas M, Bodtger U. Breathing Exercises for Patients with Asthma in Specialist Care: A Multicenter Randomized Clinical Trial. Ann Am Thorac Soc. 2022 Sep;19(9):1498-1506. doi: 10.1513/AnnalsATS.202111-1228OC.
PubMed 35588357Stern J, Pier J, Litonjua AA. Asthma epidemiology and risk factors. Semin Immunopathol. 2020 Feb;42(1):5-15. doi: 10.1007/s00281-020-00785-1. Epub 2020 Feb 4.
PubMed 32020334Vagedes J, Helmert E, Kuderer S, Vagedes K, Wildhaber J, Andrasik F. The Buteyko breathing technique in children with asthma: a randomized controlled pilot study. Complement Ther Med. 2021 Jan;56:102582. doi: 10.1016/j.ctim.2020.102582. Epub 2020 Oct 23.
PubMed 33197659Coulson E, Carpenter LM, Georgia TE, Baptist AP. Breathing exercises in older adults with asthma: a blinded, randomized, placebo-controlled trial. J Asthma. 2022 Jul;59(7):1438-1444. doi: 10.1080/02770903.2021.1936015. Epub 2021 Jun 14.
PubMed 34044738Das RR, Sankar J, Kabra SK. Role of Breathing Exercises in Asthma-Yoga and Pranayama. Indian J Pediatr. 2022 Feb;89(2):174-180. doi: 10.1007/s12098-021-03998-w. Epub 2021 Nov 23.
PubMed 34812995
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects Of Buteyko Breathing Techniques And Papworth Method On Pulmonary Functions And Oxygen Saturation In Asthmatic Patients
- ClinicalTrials.gov ID
- NCT05931952
- Acronym / sponsor ID
- REC/RCR&AHS/23/0319
- Conditions
- Asthma
- Keywords
- asthma,, breathing exercises, humans, oxygen saturation,, patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 5 Dec 2023 (actual)
- First posted
- 6 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.
Asthma is an inflammatory condition which is characterized by coughing, sneezing, and shortness of breath. The ratio of asthma is increasing day by day around the globe. According to an estimate, more than 300 million people are affected from this chronic respiratory disorder throughout the world. The asthma is diagnosis on basis of sign and symptoms as there is no gold standard of evaluating the asthma. There are basically two treatment strategies for asthma involving medical management and physiotherapy treatment. In medical treatment, steroid drugs and bronchodilators are given to asthmatic patients. Now a day, the physiotherapy treatment has gained much importance. There are numerous physiotherapy approaches available for rehabilitating asthma patients such as breathing techniques, yoga, and relaxation exercises. Buteyko technique includes three steps (control pause, shallow breathing and combination of step 1 \& 2). While, papworth method includes five steps (breathing, education, relaxation, combination of breathing and relaxation exercise and home exercises). The randomized clinical trials will be conducted for this study and data will be calculated using simple random sampling technique. The study will be carried out in Clinical Private (Farooq Clinic) setting Khushab and THQ Khushab for a period of 10 months after approval from research and ethical committee. Firstly, consent will be taken from the study participants. Screening will be done using WHO Quality of Life Scale questionnaire and asthma control test adult scores. Lung spirometry values (FVC, FEV1, \& FEV1/FVC) and oxygen saturation will be evaluated at baseline, 2 weeks, and 4 weeks. Patients will be divided into two groups. Group A \& Group B. Buteyko breathing technique will be performed to Group A patients and papworth method will be performed to Group B. Chest physiotherapy will be performed to both groups as a conservative treatment at baseline, 2 weeks, and 4weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buteyko breathing technique | Experimental | Other: Buteyko breathing techniqueButeyko breathing technique and conventional (chest physiotherapy) treatment for 5 times a week for about 20 minutes in one session for a period of 4 weeks. There are three steps involved in buteyko breathing technique. Step 1; control pause breathing test (patient is asked to sit in an upright position and take normal breath. After this, asked the patient to take small breath-in for 2s and out for 3s. Control pause phase should not exceed for >30 seconds). Step 2; maximum pause or shallow breathing (patient is asked to place fingers under the nose to monitor inflow of air. 2 or 3 flickers of air is taken in and exhale as slowly as possible). Step 3; combine step 1 and 2. Bronchial drainage will be performed as a conventional treatment for 2 to 3 minutes in each segment. During that time, patient is asked to take deep and slow breaths followed by cough to help in clearing mucus. |
| Papworth method | Experimental | Other: Papworth methodPapworth method and conventional chest physiotherapy (bronchial drainage) treatment. Intervention will be given for a period of 5 sessions per week for 1 month. Duration of each session will be 20 minutes. This technique is performed particularly during remission period that make it feasible for respiratory physiotherapist to integrate this method into activities of daily living. Papworth method has five components including Papworth method ameliorates asthmatic symptoms breathing, education, relaxation, combination of breathing and relaxation exercise and home exercises and also improves quality of life. Bronchial drainage will be performed as a conventional treatment for 2 to 3 minutes in each segment. During that time, patient is asked to take deep and slow breaths followed by cough to help in clearing mucus. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Diagnosed asthmatic patients
- Age group 20-60 years
- Both genders
- Lung function (FEV predicted < 80% \& FEV1/FVC < 75%)
- Nighttime awakening 3-4 times/month
Key exclusion criteria (4 listed)
- Unstable asthmatic patients
- Acute upper respiratory infection
- History of radiation
- Taking any oral steroid, mental disorder
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 techniqueGroup A: Buteyko breathing technique and conventional (chest physiotherapy) treatment for 5 times a week for about 20 minutes in one session for a period of 4 weeks. There are three steps involved in buteyko breathing technique. Step 1; control pause breathing test (patient is asked to sit in an upright position and take normal breath. After this, asked the patient to take small breath-in for 2s and out for 3s. Control pause phase should not exceed for >30 seconds). Step 2; maximum pause or shallow breathing (patient is asked to place fingers under the nose to monitor inflow of air. 2 or 3 flickers of air is taken in and exhale as slowly as possible). Step 3; combine step 1 and 2. Bronchial drainage will be performed as a conventional treatment for 2 to 3 minutes in each segment. During that time, patient is asked to take deep and slow breaths followed by cough to help in clearing mucus. | Other | Buteyko breathing technique |
| Papworth methodPapworth method and conventional chest physiotherapy (bronchial drainage) treatment. Intervention will be given for a period of 5 sessions per week for 1 month. Duration of each session will be 20 minutes. This technique is performed particularly during remission period that make it feasible for respiratory physiotherapist to integrate this method into activities of daily living. Papworth method has five components including Papworth method ameliorates asthmatic symptoms breathing, education, relaxation, combination of breathing and relaxation exercise and home exercises and also improves quality of life. Bronchial drainage will be performed as a conventional treatment for 2 to 3 minutes in each segment. During that time, patient is asked to take deep and slow breaths followed by cough to help in clearing mucus. | Other | Papworth method |
Primary outcome
PFT to assess change
Time frame: baseline and fourth week
It is the Pulmonary Function Test and these tests are used to measure lungs functions. These are specifically necessary for diagnosis of respiratory diseases. The data calculated from PFT include Force Vital Capacity (FVC), Force Expiratory Volume at 1 second (FEV1), and FEV1/FVC
Asthma Control Test Adult (ACT) to assess change
Time frame: baseline and fourth week
Asthma Control Test (ACT) is a clinical tool for evaluation of symptoms of asthmatic patients. It is a 5-item questionnaire for the assessment of patient-reported asthma control. The study has illustrated that this tool has content validity
WHOQOL to assess change
Time frame: baseline and fourth week
This questionnaire was represented by the WHO (World Health Organization) and it is used to assess quality and wellbeing of an individual. The study has elaborated the validity and reliability of this tool. Low score on this scale indicates depression and anxiety like symptoms
Oximeter to assess change
Time frame: baseline and fourth week
It is an instrument which is used to evaluate oxygen level of blood. This test is performed in various lungs and heart diseases. It is a painless and non-invasive procedure of measuring oxygen saturation. It simply works by placing the device on finger
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 27 Dec 2023.
- Background: PubMed 35588357Andreasson KH, Skou ST, Ulrik CS, Madsen H, Sidenius K, Assing KD, Porsbjerg C, Bloch-Nielsen J, Thomas M, Bodtger U. Breathing Exercises for Patients with Asthma in Specialist Care: A Multicenter Randomized Clinical Trial. Ann Am Thorac Soc. 2022 Sep;19(9):1498-1506. doi: 10.1513/AnnalsATS.202111-1228OC.
- Background: PubMed 32020334Stern J, Pier J, Litonjua AA. Asthma epidemiology and risk factors. Semin Immunopathol. 2020 Feb;42(1):5-15. doi: 10.1007/s00281-020-00785-1. Epub 2020 Feb 4.
- Background: PubMed 33197659Vagedes J, Helmert E, Kuderer S, Vagedes K, Wildhaber J, Andrasik F. The Buteyko breathing technique in children with asthma: a randomized controlled pilot study. Complement Ther Med. 2021 Jan;56:102582. doi: 10.1016/j.ctim.2020.102582. Epub 2020 Oct 23.
- Background: PubMed 34044738Coulson E, Carpenter LM, Georgia TE, Baptist AP. Breathing exercises in older adults with asthma: a blinded, randomized, placebo-controlled trial. J Asthma. 2022 Jul;59(7):1438-1444. doi: 10.1080/02770903.2021.1936015. Epub 2021 Jun 14.
- Background: PubMed 34812995Das RR, Sankar J, Kabra SK. Role of Breathing Exercises in Asthma-Yoga and Pranayama. Indian J Pediatr. 2022 Feb;89(2):174-180. doi: 10.1007/s12098-021-03998-w. Epub 2021 Nov 23.
- 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 Afzal, PP-DPT 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 technique and Papworth method 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 6 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 27 Dec 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?
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?
PFT to assess change (time frame: baseline and fourth week). The study lists 4 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 NCT05931952, which also lists 5 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 27 Dec 2023.