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Comparative Effects of ACBT and Diaphragmatic Breathing on Pulmonary Function and Sputum Diary After CABG

Primary Purpose

Breathing Exercises

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Active cycle of breathing technique
diaphragmatic breathing
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breathing Exercises focused on measuring diaphragmatic exercise, pulmonary function test

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Sadiq Saadiq hospital Gujranwala, DHQ hospital GujranwalaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Active cycle of breathing technique

diaphragmatic breathing

Arm Description

Group A will receive ACBTs with 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Borg Rating of Perceived scale
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.

Full Information

First Posted
June 14, 2023
Last Updated
July 7, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05936788
Brief Title
Comparative Effects of ACBT and Diaphragmatic Breathing on Pulmonary Function and Sputum Diary After CABG
Official Title
Comparative Effects of Active Cycle of Breathing Technique and Diaphragmatic Breathing on Pulmonary Function and Sputum Diary After Coronary Artery Bypass Graft
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
October 10, 2023 (Anticipated)
Study Completion Date
November 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breathing Exercises
Keywords
diaphragmatic exercise, pulmonary function test

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
Participant
Masking Description
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
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active cycle of breathing technique
Arm Type
Experimental
Arm Description
Group A will receive ACBTs with 1 session a day for total 2 days in a week.
Arm Title
diaphragmatic breathing
Arm Type
Experimental
Arm Description
Group B will receive diaphragmatic breathing for 1 session a day for total 2 days in a week.
Intervention Type
Other
Intervention Name(s)
Active cycle of breathing technique
Intervention Description
Group A will receive ACBTs with 1 session a day for total 2 days in a week.
Intervention Type
Other
Intervention Name(s)
diaphragmatic breathing
Intervention Description
Group B will receive diaphragmatic breathing for 1 session a day for total 2 days in a week.
Primary Outcome Measure Information:
Title
6 Min walk test
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Borg Rating of Perceived scale
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Iqbal Tariq, PHD
Phone
O3338236752
Email
iqbal.tariq@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sidra Faisal, MS.CPPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sadiq Saadiq hospital Gujranwala, DHQ hospital Gujranwala
City
Gujranwala,
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sidra Faisal, MS.CPPT
Phone
03022001847
Email
sidra.faisal@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Ghazia Asmat, DPT

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30152648
Citation
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.
Results Reference
background
PubMed Identifier
22924127
Citation
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.
Results Reference
background
PubMed Identifier
34082905
Citation
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.
Results Reference
background
PubMed Identifier
28838589
Citation
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.
Results Reference
background
PubMed Identifier
30217621
Citation
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.
Results Reference
background
PubMed Identifier
22211147
Citation
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.
Results Reference
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Comparative Effects of ACBT and Diaphragmatic Breathing on Pulmonary Function and Sputum Diary After CABG

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