NCT05936788

Brief Summary

To compare the effects of active cycle of breathing technique and diaphragmatic breathing on pulmonary functions and sputum diary after coronary artery bypass graf

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

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

First Submitted

Initial submission to the registry

June 14, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

June 15, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2023

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

June 14, 2023

Last Update Submit

June 11, 2024

Conditions

Keywords

diaphragmatic exercisepulmonary function test

Outcome Measures

Primary Outcomes (1)

  • 6 Min walk test

    The 6 min walk test is a sub-maximal exercise test used to assess aerobic capacity and endurance.It is also use to monitor your response to treatments for heart lung and other health problems. Provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.

    4 weeks

Secondary Outcomes (1)

  • Borg Rating of Perceived scale

    4 weeks

Study Arms (2)

Active cycle of breathing technique

EXPERIMENTAL

Group A will receive ACBTs with 1 session a day for total 2 days in a week.

Other: Active cycle of breathing technique

diaphragmatic breathing

EXPERIMENTAL

Group B will receive diaphragmatic breathing for 1 session a day for total 2 days in a week.

Other: diaphragmatic breathing

Interventions

Group A will receive ACBTs with 1 session a day for total 2 days in a week.

Active cycle of breathing technique

Group B will receive diaphragmatic breathing for 1 session a day for total 2 days in a week.

diaphragmatic breathing

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Post-CABG patients
  • Gender: males and females
  • Have speaking, hearing and cognitive ability
  • On mechanical ventilation for ≤ 24 h after CABG

You may not qualify if:

  • Prior history of open heart surgery
  • Prior severe pulmonary/hepatic or renal disease- Complications after CABG (cardiogenic shock, bleeding requiring transfusion, acute kidney injury, cardiac temponade and severe hypotension)
  • Life-threatening arrhythmias (ventricular fibrillation, ventricular tachycardia, atrial fibrillation)
  • On mechanical ventilator for more than 24 h after CABG
  • Pulmonary complications (atelectasis, acute respiratory distress syndrome (ARDS), diaphragmatic injury)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sadiq Saadiq hospital Gujranwala, DHQ hospital Gujranwala

Gujranwala, Punjab Province, 54000, Pakistan

Location

Related Publications (6)

  • Jasani N, Awad NT, Raut C. Effect of Coronary Artery Bypass Grafting Surgery on Pulmonary Function Tests and Arterial Blood Gases. Indian J Chest Dis Allied Sci. 2016 Jul;58(3):161-164.

    PMID: 30152648BACKGROUND
  • Urell C, Westerdahl E, Hedenstrom H, Janson C, Emtner M. Lung Function before and Two Days after Open-Heart Surgery. Crit Care Res Pract. 2012;2012:291628. doi: 10.1155/2012/291628. Epub 2012 Aug 8.

    PMID: 22924127BACKGROUND
  • Ono M, Serruys PW, Hara H, Kawashima H, Gao C, Wang R, Takahashi K, O'Leary N, Wykrzykowska JJ, Sharif F, Piek JJ, Garg S, Mack MJ, Holmes DR, Morice MC, Head SJ, Kappetein AP, Thuijs DJFM, Noack T, Davierwala PM, Mohr FW, Cohen DJ, Onuma Y; SYNTAX Extended Survival Investigators. 10-Year Follow-Up After Revascularization in Elderly Patients With Complex Coronary Artery Disease. J Am Coll Cardiol. 2021 Jun 8;77(22):2761-2773. doi: 10.1016/j.jacc.2021.04.016.

    PMID: 34082905BACKGROUND
  • Moradian ST, Najafloo M, Mahmoudi H, Ghiasi MS. Early mobilization reduces the atelectasis and pleural effusion in patients undergoing coronary artery bypass graft surgery: A randomized clinical trial. J Vasc Nurs. 2017 Sep;35(3):141-145. doi: 10.1016/j.jvn.2017.02.001.

    PMID: 28838589BACKGROUND
  • Montrief T, Koyfman A, Long B. Coronary artery bypass graft surgery complications: A review for emergency clinicians. Am J Emerg Med. 2018 Dec;36(12):2289-2297. doi: 10.1016/j.ajem.2018.09.014. Epub 2018 Sep 8.

    PMID: 30217621BACKGROUND
  • Rademacher J, Welte T. Bronchiectasis--diagnosis and treatment. Dtsch Arztebl Int. 2011 Dec;108(48):809-15. doi: 10.3238/arztebl.2011.0809. Epub 2011 Dec 2.

    PMID: 22211147BACKGROUND

Study Officials

  • Sidra Faisal, MS.CPPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
There will be 2 groups i.e. group A will receive active cycle of breathing technique (ACBT) and group B will receive diaphragmatic breathing technique. Spirometer will be used to evaluate pulmonary functions and breathless, cough and sputum scale (BCSS) will be used to evaluate the improvement in sputum diary of patients. The trial will be completed in two days after patients admitted in the ICUs/CCUs and before and after each session, primary and secondary outcomes will be measured for both groups. A
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: There will be 2 groups i.e. group A will receive active cycle of breathing technique (ACBT) and group B will receive diaphragmatic breathing technique. Spirometer will be used to evaluate pulmonary functions and breathless, cough and sputum scale (BCSS) will be used to evaluate the improvement in sputum diary of patients. The trial will be completed in two days after patients admitted in the ICUs/CCUs and before and after each session, primary and secondary outcomes will be measured for both groups. A
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2023

First Posted

July 10, 2023

Study Start

June 15, 2023

Primary Completion

August 10, 2023

Study Completion

November 20, 2023

Last Updated

June 13, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations