NCT05425095

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
Last Updated

February 1, 2023

Status Verified

January 1, 2023

Enrollment Period

8 months

First QC Date

June 15, 2022

Last Update Submit

January 31, 2023

Conditions

Post-Cardiac Surgery Patients

Keywords

Cardiac surgeryButeyko breathing techniqueCorpse poseYogaQuality of lifePhysical HealthShort-form health survey SF-36

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 Week

Study Arms (2)

Buteyko Breathing Technique

EXPERIMENTAL

Group A

Other: Buteyko Breathing Technique

Corpse-Pose Technique

EXPERIMENTAL

Group B

Other: Corpse-Pose Technique

Interventions

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.

Buteyko Breathing Technique
Corpse-Pose TechniqueOTHER

Group B will be treated with Corpse-Pose Technique for 15-20 min.

Corpse-Pose Technique

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stable Post-Op Cardiac Surgery Patients (Post-3 months)
  • Both genders.
  • Age 40-70.

You may not qualify if:

  • Patients on other medications. (Corticosteroids)
  • Patients with underlying severe medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiac Rehabilitation Centre of Faisalabad institute of cardiology Hospital

Faisalabad, Punjab Province, 38000, Pakistan

Location

Related Publications (6)

  • 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/

    PMID: 30507109BACKGROUND

  • 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.

    PMID: 31187410BACKGROUND

  • 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.

    PMID: 29189045BACKGROUND

  • 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.

    PMID: 29580777BACKGROUND

  • 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.

    PMID: 32121371BACKGROUND

  • 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.

    PMID: 33585722BACKGROUND

Study Officials

  • Hafiza Muriam Ghani, MSPT-CP

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2022

First Posted

June 21, 2022

Study Start

June 1, 2022

Primary Completion

January 30, 2023

Study Completion

January 30, 2023

Last Updated

February 1, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)