- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06476756
Combined Effects of Active Cycle Breathing Technique and Buteyko Technique in Post Sternotomy Patients
June 24, 2024 updated by: Riphah International University
Combined Effects of Active Cycle Breathing Technique and Buteyko Technique on Airway Clearance in Post Sternotomy Patients
This randomized clinical trial seeks to compare the efficacy of the Active Cycle of Breathing Technique (ACBT) and Buteyko breathing techniques in sternotomy patients undergoing coronary artery bypass graft (CABG) surgery, aged 30 to 60.
Data will be collected from Surgical Intensive Care Unit (ICU) in selected hospitals.
Participants will be assigned to intervention to receiving ACBT and Buteyko breathing techniques standard protocol including chest percussion , tissue blowing exercises, incentive spirometer , cough technique, breathing control, deep breathing, and deep breathing techniques.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This randomized clinical trial seeks to compare the efficacy of the Active Cycle of Breathing Technique (ACBT) and Buteyko breathing techniques in sternotomy patients undergoing coronary artery bypass graft (CABG) surgery, aged 30 to 60.
Data will be collected from Surgical Intensive Care Unit (ICU) in selected hospitals.
Participants will be assigned to intervention to receiving ACBT and Buteyko breathing techniques standard protocol including chest percussion , tissue blowing exercises, incentive spirometer , cough technique, breathing control, deep breathing, and deep breathing techniques.
The three-day trial, starting upon ICU/CCU admission, will measure primary and secondary outcomes before and after each session for both groups.
Statistical analysis using SPSS version 25 will be employed post data collection.
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: Imran Amjad, PhD
- Phone Number: 03324390125
- Email: Imran.amjad@riphah.edu.pk
Study Contact Backup
- Name: Iqbal Tariq, PHD
- Phone Number: O3338236752
- Email: iqbal.tariq@riphah.edu.pk
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- Recruiting
- Gulab Devi teaching hospital
-
Contact:
- Sidra Faisal, MS.CPPT
- Phone Number: 03022001847
- Email: sidra.faisal@riphah.edu.pk
-
-
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:
- Age 40-60 years
- Patient underwent cardiac surgery for first time
- Having speaking, hearing, cognitive ability
- Both genders ( Male and female)
- On mechanical ventilation for less than 24h after surgery
Exclusion Criteria:
• Hemodynamic ally unstable patients
- Patients with reopening of sternum
- Infection patients
- Renal failure
- Arrhythmia
- Patient on mechanical ventilator
- Cancer
- Tuberculosis
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ACTIVE CYCLE OF BREATHING TECHNIQUE
Group A: combine effects of ACBT and Buteyko techniques will be performed first 3days of cardiac rehab phase 1.
|
Group A: combine effects of ACBT and Buteyko techniques will be performed first 3days of cardiac rehab phase 1.
|
|
Experimental: Buteyko techniques
Group B: effect of buteyko techniques will be performed first three days of cardiac rehab phase 1.
|
Group B: effect of buteyko techniques will be performed first three days of cardiac rehab phase 1.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Borg dyspnea scale
Time Frame: base line and 4 week
|
The Borg RPE scale rates exertion from a scale of 6 (no exertion) to 20 (maximum effort).
A rating between 12 to 14 typically reflects a moderate or somewhat hard level of intensity.
|
base line and 4 week
|
|
BREATHLESSNESS, COUGH AND SPUTUM SCALE (BCSS)
Time Frame: 4 weeks
|
The BCSS is a three-item patient-reported questionnaire that rates sputum, cough, and dyspnea .
This instrument can identify a disease aggravation with sensitivity and specificity.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sidra Faisal, PP-DPT, 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
- Cappello IA, Candelari M, Pannone L, Monaco C, Bori E, Talevi G, Ramak R, La Meir M, Gharaviri A, Chierchia GB, Innocenti B, de Asmundis C. 3D Printed Surgical Guide for Coronary Artery Bypass Graft: Workflow from Computed Tomography to Prototype. Bioengineering (Basel). 2022 Apr 19;9(5):179. doi: 10.3390/bioengineering9050179.
- Frak W, Wojtasinska A, Lisinska W, Mlynarska E, Franczyk B, Rysz J. Pathophysiology of Cardiovascular Diseases: New Insights into Molecular Mechanisms of Atherosclerosis, Arterial Hypertension, and Coronary Artery Disease. Biomedicines. 2022 Aug 10;10(8):1938. doi: 10.3390/biomedicines10081938.
- Kamiya K, Takei M, Nagai T, Miyoshi T, Ito H, Fukumoto Y, Obara H, Kakuma T, Sakuma I, Daida H, Iimuro S, Shimokawa H, Kimura T, Nagai R, Anzai T. Association between Non-Lipid Residual Risk Factors and Cardiovascular Events in Patients with Stable Coronary Artery Disease Treated with Pitavastatin: An Observation from the REAL-CAD Study. J Atheroscler Thromb. 2024 Jan 1;31(1):61-80. doi: 10.5551/jat.64304. Epub 2023 Aug 11.
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)
March 10, 2024
Primary Completion (Estimated)
July 15, 2024
Study Completion (Estimated)
August 20, 2024
Study Registration Dates
First Submitted
June 12, 2024
First Submitted That Met QC Criteria
June 24, 2024
First Posted (Actual)
June 26, 2024
Study Record Updates
Last Update Posted (Actual)
June 26, 2024
Last Update Submitted That Met QC Criteria
June 24, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- REC/RCR & AHS/23/0375
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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