- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07034937
- Original Trial
Aerobic and Resistance Training in Post-CABG Patients
June 19, 2025 updated by: Universitas Padjadjaran
Effect of Combination Aerobic and Resistance Training on Diaphragm Excursion Value and Pulmonary Functions in Post Coronary Artery Bypass Grafting Patients
This study investigates the effect of combined aerobic and resistance training using resistance bands on diaphragmatic excursion and pulmonary function (FVC, FEV₁, PEF) in post-CABG patients undergoing phase II cardiac rehabilitation.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Detailed Description
This quasi-experimental study with a pretest-posttest design evaluates the impact of a 6-week structured aerobic and resistance training program using resistance bands on the diaphragm excursion and pulmonary function.
Conducted at the rehabilitation polyclinics of Hasan Sadikin and Al Ihsan hospitals, this study includes post-CABG patients meeting specific inclusion criteria.
Intervention is performed twice a week and includes treadmill walking and upper/lower limb resistance exercises.
Outcomes will be assessed via ultrasound for diaphragm excursion and spirometry for lung function.
Study Type
Interventional
Enrollment (Estimated)
15
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: Dian M. Sari, MD., M.Sc., Ph.D
- Phone Number: +62 812 2181 2279
- Email: dian.marta@unpad.ac.id
Study Contact Backup
- Name: Nurul Aini, MD
- Phone Number: +62 856 4079 0029
- Email: drnurulaini06@gmail.com
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:
- Patients post-CABG surgery maximum 12 weeks after the procedure
- Age 40-65 years
- Visual and hearing health
- Ready to participate in research and sign informed consent.
Exclusion Criteria:
- Blood pressure greater than 160 mmHg for systolic and diastolic blood pressure greater than 100 mmHg
- Patients with contraindications to aerobic and resistance training, such as fractures that limit movement.
- Patients undergoing other therapies that may affect diaphragmatic muscle measurement results, such as electrical diaphragmatic stimulation.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Aerobic and Resistance Training Group
|
Combination of aerobic training (treadmill walking) and resistance training using resistance bands for deltoid, biceps, triceps, and quadriceps muscles.
Conducted twice weekly for 6 weeks (12 sessions).
Tools include treadmill and theraband loop bands.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diaphragm Excursion (cm)
Time Frame: Baseline to Week 6
|
The vertical movement of the diaphragm during the respiratory cycle shows the function and mobility of the diaphragm in the process of pulmonary ventilation. The data obtained is expressed in cm. Measured via ultrasound. |
Baseline to Week 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Forced Vital Capacity (FVC)
Time Frame: Baseline to Week 6
|
Lung function Forced Vital Capacity (FVC) is commonly assessed through spirometry and measured in liters (L) FVC: This measures the total volume of air that can be forcibly exhaled after a full inhalation.
FVC values less than 80% of the predicted value are indicative of restrictive respiratory impairments, where the lungs cannot fully expand.
FVC values equal to or greater than 80% are considered normal.
|
Baseline to Week 6
|
|
Forced Expiratory Volume in one second (FEV1)
Time Frame: Baseline to Week 6
|
Lung function Forced Expiratory Volume in one second (FEV1) is commonly assessed through spirometry and measured in liters (L) FEV1: This represents the air volume a person can forcefully exhale in the first second of a breath.
|
Baseline to Week 6
|
|
Peak Expiratory Flow (PEF)
Time Frame: Baseline to Week 6
|
Peak Expiratory Flow (PEF) is a spirometric parameter that measures the maximum airflow achieved at the beginning of a forced expiration, expressed in liters per second or minute.
It reflects the function of the large airways and expiratory muscle strength.
PEF interpretation is based on the percentage of predicted values according to age, sex, and height: ≥80% is considered normal, 60-79% indicates a mild reduction, 40-59% moderate reduction, and <40% signifies a severe reduction.
|
Baseline to Week 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Dian M Sari, MD., M.Sc., Ph.D, Faculty of Medicine Universitas Padjadjaran Bandung
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 (Estimated)
August 1, 2025
Primary Completion (Estimated)
April 1, 2026
Study Completion (Estimated)
July 30, 2026
Study Registration Dates
First Submitted
June 9, 2025
First Submitted That Met QC Criteria
June 19, 2025
First Posted (Actual)
June 24, 2025
Study Record Updates
Last Update Posted (Actual)
June 24, 2025
Last Update Submitted That Met QC Criteria
June 19, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IKFR-202506.01
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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