- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05425095
Comparative Effects of Buteyko Exercise and Corpse-Pose Technique on Cardiac Surgery Patients
January 23, 2023 updated by: Riphah International University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Punjab
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Faisalabad, Punjab, Pakistan, 38000
- Cardiac Rehabilitation Centre of Faisalabad institute of cardiology Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Stable Post-Op Cardiac Surgery Patients (Post-3 months)
- Both genders.
- Age 40-70.
Exclusion Criteria:
- Patients on other medications. (Corticosteroids)
- Patients with underlying severe medical conditions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Buteyko Breathing Technique
Group A
|
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.
|
|
Experimental: Corpse-Pose Technique
Group B
|
Group B will be treated with Corpse-Pose Technique for 15-20 min.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
4 Week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hafiza Muriam Ghani, MSPT-CP, Riphah International University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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/
- Haraldstad 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.
- Chen 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.
- Grand 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.
- Shah 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.
- Guzelhan 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2022
Primary Completion (Actual)
December 25, 2022
Study Completion (Actual)
December 31, 2022
Study Registration Dates
First Submitted
June 15, 2022
First Submitted That Met QC Criteria
June 15, 2022
First Posted (Actual)
June 21, 2022
Study Record Updates
Last Update Posted (Estimate)
January 25, 2023
Last Update Submitted That Met QC Criteria
January 23, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/22/0322
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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