Breathing ExercisesNCT05936788
Comparative Effects of ACBT and Diaphragmatic Breathing on Pulmonary Function and Sputum Diary After CABG
A study testing Active cycle of breathing technique and diaphragmatic breathing in people with Breathing Exercises, run by Riphah International University at 1 site in Pakistan.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Breathing Exercises
- What is being tested?
- Active cycle of breathing technique and diaphragmatic breathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jun 2023to 20 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Post-CABG patients
- Gender: males and females
- Have speaking, hearing and cognitive ability
- On mechanical ventilation for ≤ 24 h after CABG
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Sadiq Saadiq hospital Gujranwala, DHQ hospital Gujranwala
Gujranwala, Punjab Province, 54000
About this study
Official title: 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
Read the 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
- Conditions
- Breathing Exercises
- Being tested
- Active cycle of breathing technique, diaphragmatic breathing
- Keywords
- diaphragmatic exercise, pulmonary function test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active cycle of breathing techniqueOther
Group A will receive ACBTs with 1 session a day for total 2 days in a week.
diaphragmatic breathingOther
Group B will receive diaphragmatic breathing for 1 session a day for total 2 days in a week.
| Study group | Role | What they receive |
|---|---|---|
| Active cycle of breathing technique | Experimental | Group A will receive ACBTs with 1 session a day for total 2 days in a week. Receives: 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. Receives: Other: diaphragmatic breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (1)
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start15 Jun 2023
- Primary completion10 Aug 2023
- Study completion20 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Breathing ExercisesStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sidra Faisal, MS.CPPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05936788
- Sponsor's protocol ID
- REC/RCR & AHS/23/0310
- Status last verified
- Jun 2024
- First submitted
- 14 Jun 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30152648Urell 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.
PubMed 22924127Ono 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.
PubMed 34082905Moradian 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.
PubMed 28838589Montrief 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.
PubMed 30217621Rademacher 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.
PubMed 22211147
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Active Cycle of Breathing Technique and Diaphragmatic Breathing on Pulmonary Function and Sputum Diary After Coronary Artery Bypass Graft
- ClinicalTrials.gov ID
- NCT05936788
- Acronym / sponsor ID
- REC/RCR & AHS/23/0310
- Conditions
- Breathing Exercises
- Keywords
- diaphragmatic exercise, pulmonary function test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Active cycle of breathing technique | Experimental | Other: Active cycle of breathing techniqueGroup A will receive ACBTs with 1 session a day for total 2 days in a week. |
| diaphragmatic breathing | Experimental | Other: diaphragmatic breathingGroup B will receive diaphragmatic breathing for 1 session a day for total 2 days in a week. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Post-CABG patients
- Gender: males and females
- Have speaking, hearing and cognitive ability
- On mechanical ventilation for ≤ 24 h after CABG
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active cycle of breathing techniqueGroup A will receive ACBTs with 1 session a day for total 2 days in a week. | Other | Active cycle of breathing technique |
| diaphragmatic breathingGroup B will receive diaphragmatic breathing for 1 session a day for total 2 days in a week. | Other | diaphragmatic breathing |
Primary outcome
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.
1 secondary outcome
Borg Rating of Perceived scale
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Background: PubMed 30152648Jasani 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.
- Background: PubMed 22924127Urell 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.
- Background: PubMed 34082905Ono 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.
- Background: PubMed 28838589Moradian 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.
- Background: PubMed 30217621Montrief 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.
- Background: PubMed 22211147Rademacher 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sidra Faisal, MS.CPPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active cycle of breathing technique and diaphragmatic breathing in people with Breathing Exercises, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 Min walk test (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05936788, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.