Post-Cardiac Surgery PatientsNCT05425095
Comparative Effects of Buteyko Exercise and Corpse-Pose Technique on Cardiac Surgery Patients
A study testing Buteyko Breathing Technique and Corpse-Pose Technique in people with Post-Cardiac Surgery Patients, run by Riphah International University at 1 site in Pakistan.
Trial summary
Open-heart surgeries such as coronary artery bypass grafting and valve replacements have been used to improve patient outcomes related to cardiac symptoms, prolongation of life, and health-related quality of life. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Post-Cardiac Surgery Patients
- What is being tested?
- Buteyko Breathing Technique and Corpse-Pose Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2022to 30 Jan 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable Post-Op Cardiac Surgery Patients (Post-3 months)
- Both genders.
- Age 40-70.
Who cannot join
- Patients on other medications. (Corticosteroids)
- Patients with underlying severe medical conditions
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Cardiac Rehabilitation Centre of Faisalabad institute of cardiology Hospital
Faisalabad, Punjab Province, 38000
About this study
Official title: Comparative Effects of Buteyko Exercise and Corpse-Pose Technique on Physical Health and Quality of Life in Post-Cardiac Surgery Patients
Open-heart surgeries such as coronary artery bypass grafting and valve replacements have been used to improve patient outcomes related to cardiac symptoms, prolongation of life, and health-related quality of life. Recovery from cardiac surgery is not entirely determined by physical attributes and medical treatment, but social and psychological factors may also influence the process of postoperative short and long-term recovery. The objective of this study is to find out the Comparative Effects of Buteyko Exercise and Corpse-Pose Technique on Physical Health and Quality of Life in Post-Cardiac Surgery Patients. This study will be a Randomized controlled trial and will be conducted in Faisalabad institute of cardiology after ethical approval. The study will be completed within the duration of 10 months after approval of synopsis. Nonprobability convenience sampling technique will be used. The sample size of 46 patients will be taken: 25 post-cardiac surgery patients in each group with a 10% attrition rate. There will be two groups in this study one will be given with the Buteyko breathing technique and other will be provided with corpse-pose technique. Treatment protocol for both techniques will be 4 weeks with 3 sets per day. A pre assessment at week 1 and a final assessment at week 4 will be made by using SF-36 questionnaire. Data will be analyzed on SPSS-25.
- Conditions
- Post-Cardiac Surgery Patients
- Being tested
- Buteyko Breathing Technique, Corpse-Pose Technique
- Keywords
- Cardiac surgery, Buteyko breathing technique, Corpse pose, Yoga, Quality of life, Physical Health, Short-form health survey SF-36
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buteyko Breathing TechniqueOther
Group A will be treated with Buteyko Breathing Technique. Patient in a relaxed sitting position will ask to take a gentle breath in (2 sec), breath out (3sec) followed by pinching the nose with hands to hold the breath. The therapist will count the no. of seconds the patient can comfortably hold the breath until feels the need to breathe in again. Followed by releasing the nose and continue breathing.
Corpse-Pose TechniqueOther
Group B will be treated with Corpse-Pose Technique for 15-20 min.
| Study group | Role | What they receive |
|---|---|---|
| Buteyko Breathing Technique | Experimental | Group A Receives: Other: Buteyko Breathing Technique |
| Corpse-Pose Technique | Experimental | Group B Receives: Other: Corpse-Pose Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Form-36 Health Survey Questionnaire (SF-36)
SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes. this questionnaire has 36 scoring. 1 is minimum score and 36 is highest score.
Measured: 4 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start1 Jun 2022
- Primary completion30 Jan 2023
- Study completion30 Jan 2023
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 Post-Cardiac Surgery PatientsStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hafiza Muriam Ghani, MSPT-CP, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05425095
- Sponsor's protocol ID
- REC/RCR&AHS/22/0322
- Status last verified
- Jan 2023
- First submitted
- 15 Jun 2022
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Management of Physical Health Conditions in Adults with Severe Mental Disorders. Geneva: World Health Organization; 2018. Available from http://www.ncbi.nlm.nih.gov/books/NBK534487/
PubMed 30507109Haraldstad K, Wahl A, Andenaes R, Andersen JR, Andersen MH, Beisland E, Borge CR, Engebretsen E, Eisemann M, Halvorsrud L, Hanssen TA, Haugstvedt A, Haugland T, Johansen VA, Larsen MH, Lovereide L, Loyland B, Kvarme LG, Moons P, Norekval TM, Ribu L, Rohde GE, Urstad KH, Helseth S; LIVSFORSK network. A systematic review of quality of life research in medicine and health sciences. Qual Life Res. 2019 Oct;28(10):2641-2650. doi: 10.1007/s11136-019-02214-9. Epub 2019 Jun 11.
PubMed 31187410Chen DM, Yu WC, Hung HF, Tsai JC, Wu HY, Chiou AF. The effects of Baduanjin exercise on fatigue and quality of life in patients with heart failure: A randomized controlled trial. Eur J Cardiovasc Nurs. 2018 Jun;17(5):456-466. doi: 10.1177/1474515117744770. Epub 2017 Nov 30.
PubMed 29189045Grand N, Bouchet JB, Zufferey P, Beraud AM, Awad S, Sandri F, Campisi S, Fuzellier JF, Molliex S, Vola M, Morel J. Quality of Life After Cardiac Operations Based on the Minimal Clinically Important Difference Concept. Ann Thorac Surg. 2018 Aug;106(2):548-554. doi: 10.1016/j.athoracsur.2018.02.050. Epub 2018 Mar 23.
PubMed 29580777Shah CH, Brown JD. Reliability and Validity of the Short-Form 12 Item Version 2 (SF-12v2) Health-Related Quality of Life Survey and Disutilities Associated with Relevant Conditions in the U.S. Older Adult Population. J Clin Med. 2020 Feb 29;9(3):661. doi: 10.3390/jcm9030661.
PubMed 32121371Guzelhan Y, Ugurlucan M, Oztas DM, Beyaz MO, Unal O, Bektas N, Conkbayir C, Alpagut U, Bozbuga N. Anxiety and health-related quality of life after cardiac surgery. Arch Med Sci Atheroscler Dis. 2020 Apr 8;5:e27-e35. doi: 10.5114/amsad.2020.94376. eCollection 2020.
PubMed 33585722
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Buteyko Exercise and Corpse-Pose Technique on Physical Health and Quality of Life in Post-Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT05425095
- Acronym / sponsor ID
- REC/RCR&AHS/22/0322
- Conditions
- Post-Cardiac Surgery Patients
- Keywords
- Cardiac surgery, Buteyko breathing technique, Corpse pose, Yoga, Quality of life, Physical Health, Short-form health survey SF-36
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 21 Jun 2022 (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.
Open-heart surgeries such as coronary artery bypass grafting and valve replacements have been used to improve patient outcomes related to cardiac symptoms, prolongation of life, and health-related quality of life. Recovery from cardiac surgery is not entirely determined by physical attributes and medical treatment, but social and psychological factors may also influence the process of postoperative short and long-term recovery. The objective of this study is to find out the Comparative Effects of Buteyko Exercise and Corpse-Pose Technique on Physical Health and Quality of Life in Post-Cardiac Surgery Patients. This study will be a Randomized controlled trial and will be conducted in Faisalabad institute of cardiology after ethical approval. The study will be completed within the duration of 10 months after approval of synopsis. Nonprobability convenience sampling technique will be used. The sample size of 46 patients will be taken: 25 post-cardiac surgery patients in each group with a 10% attrition rate. There will be two groups in this study one will be given with the Buteyko breathing technique and other will be provided with corpse-pose technique. Treatment protocol for both techniques will be 4 weeks with 3 sets per day. A pre assessment at week 1 and a final assessment at week 4 will be made by using SF-36 questionnaire. Data will be analyzed on SPSS-25.
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 TechniqueGroup A |
| Corpse-Pose Technique | Experimental | Other: Corpse-Pose TechniqueGroup B |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stable Post-Op Cardiac Surgery Patients (Post-3 months)
- Both genders.
- Age 40-70.
Key exclusion criteria (2 listed)
- Patients on other medications. (Corticosteroids)
- Patients with underlying severe medical conditions
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 will be treated with Buteyko Breathing Technique. Patient in a relaxed sitting position will ask to take a gentle breath in (2 sec), breath out (3sec) followed by pinching the nose with hands to hold the breath. The therapist will count the no. of seconds the patient can comfortably hold the breath until feels the need to breathe in again. Followed by releasing the nose and continue breathing. | Other | Buteyko Breathing Technique |
| Corpse-Pose TechniqueGroup B will be treated with Corpse-Pose Technique for 15-20 min. | Other | Corpse-Pose Technique |
Primary outcome
Short Form-36 Health Survey Questionnaire (SF-36)
Time frame: 4 Week
SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes. this questionnaire has 36 scoring. 1 is minimum score and 36 is highest score.
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 1 Feb 2023.
- Background: PubMed 30507109Management of Physical Health Conditions in Adults with Severe Mental Disorders. Geneva: World Health Organization; 2018. Available from http://www.ncbi.nlm.nih.gov/books/NBK534487/
- Background: PubMed 31187410Haraldstad K, Wahl A, Andenaes R, Andersen JR, Andersen MH, Beisland E, Borge CR, Engebretsen E, Eisemann M, Halvorsrud L, Hanssen TA, Haugstvedt A, Haugland T, Johansen VA, Larsen MH, Lovereide L, Loyland B, Kvarme LG, Moons P, Norekval TM, Ribu L, Rohde GE, Urstad KH, Helseth S; LIVSFORSK network. A systematic review of quality of life research in medicine and health sciences. Qual Life Res. 2019 Oct;28(10):2641-2650. doi: 10.1007/s11136-019-02214-9. Epub 2019 Jun 11.
- Background: PubMed 29189045Chen DM, Yu WC, Hung HF, Tsai JC, Wu HY, Chiou AF. The effects of Baduanjin exercise on fatigue and quality of life in patients with heart failure: A randomized controlled trial. Eur J Cardiovasc Nurs. 2018 Jun;17(5):456-466. doi: 10.1177/1474515117744770. Epub 2017 Nov 30.
- Background: PubMed 29580777Grand N, Bouchet JB, Zufferey P, Beraud AM, Awad S, Sandri F, Campisi S, Fuzellier JF, Molliex S, Vola M, Morel J. Quality of Life After Cardiac Operations Based on the Minimal Clinically Important Difference Concept. Ann Thorac Surg. 2018 Aug;106(2):548-554. doi: 10.1016/j.athoracsur.2018.02.050. Epub 2018 Mar 23.
- Background: PubMed 32121371Shah CH, Brown JD. Reliability and Validity of the Short-Form 12 Item Version 2 (SF-12v2) Health-Related Quality of Life Survey and Disutilities Associated with Relevant Conditions in the U.S. Older Adult Population. J Clin Med. 2020 Feb 29;9(3):661. doi: 10.3390/jcm9030661.
- Background: PubMed 33585722Guzelhan Y, Ugurlucan M, Oztas DM, Beyaz MO, Unal O, Bektas N, Conkbayir C, Alpagut U, Bozbuga N. Anxiety and health-related quality of life after cardiac surgery. Arch Med Sci Atheroscler Dis. 2020 Apr 8;5:e27-e35. doi: 10.5114/amsad.2020.94376. eCollection 2020.
- 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.
Hafiza Muriam Ghani, MSPT-CP 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 Corpse-Pose Technique in people with Post-Cardiac Surgery Patients, 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 3 inclusion and 2 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 1 Feb 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?
Short Form-36 Health Survey Questionnaire (SF-36) (time frame: 4 Week). 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 NCT05425095, 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 1 Feb 2023.