- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07006441
- Original Trial
Cardiac Rehabilitation in Coronary Artery Bypass Graft Surgery
August 21, 2025 updated by: Hikmet Ucgun, Atlas University
The Effects of Preoperative and Postoperative Cardiac Rehabilitation in Patients Undergoing Coronary Artery Bypass Graft Surgery
This randomized controlled trial investigates the comparative effects of a combined preoperative and postoperative cardiac rehabilitation program versus a postoperative-only program on functional capacity, pulmonary function, peripheral muscle strength, pain, kinesiophobia, and quality of life in patients undergoing coronary artery bypass graft (CABG) surgery.
The study aims to determine whether initiating rehabilitation prior to surgery improves short-term postoperative outcomes.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
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 Locations
-
-
-
Istanbul, Turkey (Türkiye)
- İstanbul atlas university
-
-
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
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Having undergone coronary artery bypass graft surgery
- Ejection Fraction (EF) > 40%
- Being between the ages of 18-65
- Being able to speak, read and understand in their own language
- Volunteering to participate in the study
Exclusion Criteria:
- Having an active or suspected infection
- Presence of an active tumour
- History of thrombophlebitis or pulmonary embolism within the last 3 months
- Having an orthopaedic, neurological or cardiovascular disease that may affect the assessments
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: Experimental Group
Preoperative cardiac rehabilitation + postoperative cardiac rehabilitation (structured exercise, respiratory physiotherapy, and patient education)
|
Structured exercise program, respiratory physiotherapy, and patient education
Structured exercise program, respiratory physiotherapy, and patient education
|
|
Active Comparator: Control Group
Postoperative cardiac rehabilitation (structured exercise, respiratory physiotherapy, and patient education)
|
Structured exercise program, respiratory physiotherapy, and patient education
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Forced Vital Capacity (FVC)
Time Frame: 2 weeks
|
Forced Vital Capacity will be measured before six-minute walk test according to the guideline of ERS.
|
2 weeks
|
|
Forced Expiratory Volume in 1 second (FEV1)
Time Frame: 2 weeks
|
Forced Expiratory Volume in 1 second will be measured before six-minute walk test according to the guideline of ERS.
|
2 weeks
|
|
Peak Expiratory Flow (PEF)
Time Frame: 2 weeks
|
Peak Expiratory Flow will be measured before six-minute walk test according to the guideline of ERS.
|
2 weeks
|
|
Forced Expiratory Flow 25-75% (FEF25-75)
Time Frame: 2 weeks
|
Forced Expiratory Flow 25-75% will be measured before six-minute walk test according to the guideline of ERS.
|
2 weeks
|
|
6-minute Walk Test
Time Frame: 2 weeks
|
The 6-minute Walk Test will be performed according to ATS guidelines.
Walking distance, minute ventilation, respiratory rate, inspiratory capacity and breathing reserve will be recorded.
|
2 weeks
|
|
M. Quadriceps Muscle Strength
Time Frame: 2 weeks
|
The m. quadriceps muscle strength will be measured using the MicroFet 2 hand-held dynamometer (Hogan Health Industries, USA).
The test will be repeated three times for the dominant side and the average value in kilograms (kg) will be recorded.
|
2 weeks
|
|
M. Biceps Muscle Strength
Time Frame: 2 weeks
|
The m. biceps muscle strength will be measured using the MicroFet 2 hand-held dynamometer (Hogan Health Industries, USA).
The test will be repeated three times for the dominant side and the average value in kilograms (kg) will be recorded.
|
2 weeks
|
|
Cough Peak Flow
Time Frame: 2 weeks
|
Cough Peak Flow (CPF) will be measured using a peak expiratory flow meter.
Participants will be instructed to take a maximal deep breath and then cough as forcefully as possible into the device; the highest value from three trials will be recorded in liters per minute (L/min).
Measurements will be performed in a seated position, ensuring a tight mouth seal and consistent technique.
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Level of Pain
Time Frame: 2 weeks
|
Pain assessment will be performed using the Visual Analog Scale (VAS) to evaluate chest pain levels.
Participants will be asked to mark their current pain intensity on a 10 cm horizontal line, with "no pain" at one end and "worst imaginable pain" at the other.
The distance in centimeters from the "no pain" end to the mark will be measured and recorded as the pain score.
|
2 weeks
|
|
Level of Fear of Movement
Time Frame: 2 weeks
|
Fear of movement (kinesiophobia) will be assessed using the Tampa Scale for Kinesiophobia (TSK).
Participants will complete the 17-item questionnaire, which evaluates fear of movement and re-injury on a 4-point Likert scale.
The total score, ranging from 17 to 68, will be calculated, with higher scores indicating greater fear of movement.
|
2 weeks
|
|
Level of Quality of Life
Time Frame: 2 weeks
|
Quality of life will be assessed using the Short Form-36 (SF-36) Health Survey.
Participants will complete the 36-item questionnaire, which evaluates eight domains including physical functioning, bodily pain, general health, and mental well-being.
Each domain will be scored from 0 to 100, with higher scores indicating better perceived quality of life.
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hikmet Ucgun, PT, PhD, Atlas University
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)
August 1, 2024
Primary Completion (Actual)
August 1, 2025
Study Completion (Actual)
August 1, 2025
Study Registration Dates
First Submitted
May 28, 2025
First Submitted That Met QC Criteria
May 28, 2025
First Posted (Actual)
June 5, 2025
Study Record Updates
Last Update Posted (Estimated)
August 27, 2025
Last Update Submitted That Met QC Criteria
August 21, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- auhucgun04
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
product manufactured in and exported from the U.S.
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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