- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05936788
Comparative Effects of ACBT and Diaphragmatic Breathing on Pulmonary Function and Sputum Diary After CABG
July 7, 2023 updated by: Riphah International University
Comparative Effects of Active Cycle of Breathing Technique and Diaphragmatic Breathing on Pulmonary Function and Sputum Diary After Coronary Artery Bypass Graft
To compare the effects of active cycle of breathing technique and diaphragmatic breathing on pulmonary functions and sputum diary after coronary artery bypass graf
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
It will be a randomized clinical trial.
Age of selected subjects will be between 40 to 60 years and data will be collected from intensive care units (ICUs) and cardiac care units (CCUs) of selected hospitals.
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.
After data collection, data will be analyzed using SPSS version 25
Study Type
Interventional
Enrollment (Estimated)
32
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 Contact
- Name: Iqbal Tariq, PHD
- Phone Number: O3338236752
- Email: iqbal.tariq@riphah.edu.pk
Study Locations
-
-
Punjab
-
Gujranwala,, Punjab, Pakistan, 54000
- Recruiting
- Sadiq Saadiq hospital Gujranwala, DHQ hospital Gujranwala
-
Contact:
- Sidra Faisal, MS.CPPT
- Phone Number: 03022001847
- Email: sidra.faisal@riphah.edu.pk
-
Sub-Investigator:
- Ghazia Asmat, DPT
-
-
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
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Post-CABG patients
- Gender: males and females
- Have speaking, hearing and cognitive ability
- On mechanical ventilation for ≤ 24 h after CABG
Exclusion Criteria:
- 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)
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: Active cycle of breathing technique
Group A will receive ACBTs with 1 session a day for total 2 days in a week.
|
Group A will receive ACBTs with 1 session a day for total 2 days in a week.
|
Experimental: diaphragmatic breathing
Group B will receive diaphragmatic breathing for 1 session a day for total 2 days in a week.
|
Group B will receive diaphragmatic breathing for 1 session a day for total 2 days in a week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
6 Min walk test
Time Frame: 4 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Borg Rating of Perceived scale
Time Frame: 4 weeks
|
Is a way of measuring physical activity intensity level.It has a range from 6 to 20 ,scale correlates with a person heart rate or how hard they feel they are working.Ask you to rate the difficulty of your breathing.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sidra Faisal, MS.CPPT, 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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)
May 15, 2023
Primary Completion (Estimated)
October 10, 2023
Study Completion (Estimated)
November 20, 2023
Study Registration Dates
First Submitted
June 14, 2023
First Submitted That Met QC Criteria
July 7, 2023
First Posted (Actual)
July 10, 2023
Study Record Updates
Last Update Posted (Actual)
July 10, 2023
Last Update Submitted That Met QC Criteria
July 7, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/23/0310
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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