The Effect of Resistance Training on Proprotein Subtilisin Convertase Kexin 9 Level After Coronary Bypass Surgery
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
resistance training
aerobic training
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Artery Disease focused on measuring resistance training, PCSK9, coronary artery bypass grafting
Eligibility Criteria
Inclusion Criteria:
- post elective coronary artery bypass surgery
- > 18 years old
- sign informed consent
Exclusion Criteria:
- contraindications of resistance training (unstable angina, uncontrolled blood pressure (systolic > 160 mmHg diastolic > 100 mmHg), acute heart failure, pulmonary diseases, arrhythmia malignant)
- musculoskeletal pain, visual analog scale >3
- post congenital heart disease surgery
- post elective coronary artery bypass surgery with malfunction valves (operated or not)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Control group
Intervention group
Arm Description
Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program (aerobic training only)
Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program plus resistance training (aerobic and resistance training as well)
Outcomes
Primary Outcome Measures
PCSK-9 Level
this outcome measurement will be achieved by taking patient's blood sample after cardiac rehabilitation program. The method that we use to check PCSK-9 level is ELISA method
Secondary Outcome Measures
Low Density Lipoprotein
this outcome measurement will be achieved by taking patient's blood sample after cardiac rehabilitation program
Body Mass Index
Body Mass Index is calculated by calculating the measured body weight divided by the height square in measure. We take BMI data after cardiac rehabilitation program in every participant.
High-Density Lipoprotein
this outcome measurement will be achieved by taking patient's blood sample after cardiac rehabilitation program
Total Cholesterol
this outcome measurement will be achieved by taking patient's blood sample after cardiac rehabilitation program
Triglyceride
This outcome measurement will be achieved by taking the patient's blood sample after cardiac rehabilitation program
Fasting Blood Glucose
Blood glucose concentration was taken after 10-12-hour fasting. This outcome measurement will be achieved by taking the patient's blood sample after cardiac rehabilitation program
Systolic Blood Pressure
this outcome measurement will be achieved by taking the patient's blood pressure after cardiac rehabilitation program
Diastolic Blood Pressure
this outcome measurement will be achieved by taking the patient's blood pressure after cardiac rehabilitation program
Full Information
NCT ID
NCT02674659
First Posted
February 2, 2016
Last Updated
January 7, 2020
Sponsor
National Cardiovascular Center Harapan Kita Hospital Indonesia
1. Study Identification
Unique Protocol Identification Number
NCT02674659
Brief Title
The Effect of Resistance Training on Proprotein Subtilisin Convertase Kexin 9 Level After Coronary Bypass Surgery
Official Title
The Effect of Resistance Training on Proprotein Subtilisin Convertase Kexin 9 (PCSK-9) Level in Patients After Coronary Bypass Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 10, 2016 (Actual)
Primary Completion Date
September 23, 2016 (Actual)
Study Completion Date
December 18, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cardiovascular Center Harapan Kita Hospital Indonesia
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
This research add resistance training to patients who undergo cardiac rehabilitation program after coronary bypass surgery, comparing the level of PCSK9 level on that group to another group who receives conventional rehabilitation program (only aerobic exercise)
Detailed Description
The PCSK9 level measured before and after cardiac rehabilitation program (around 3-4 weeks), and compared between two groups. ELISA method will be used to measure plasma PCSK9 level.
Resistance training will be given by professional trainer in gymnasium of National Cardiovascular Center Harapan Kita supervised by cardiologists, following rules from American College of Sports Medicine guideline regarding to exercise after cardiac event.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
resistance training, PCSK9, coronary artery bypass grafting
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Experimental
Arm Description
Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program (aerobic training only)
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program plus resistance training (aerobic and resistance training as well)
Intervention Type
Behavioral
Intervention Name(s)
resistance training
Intervention Description
resistance training consists of lower and upper extremities exercises. We focus on biceps and hamstring to be trained. One session was held for around 30 minutes.
Intervention Type
Behavioral
Intervention Name(s)
aerobic training
Intervention Description
aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)
Primary Outcome Measure Information:
Title
PCSK-9 Level
Description
this outcome measurement will be achieved by taking patient's blood sample after cardiac rehabilitation program. The method that we use to check PCSK-9 level is ELISA method
Time Frame
3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
Secondary Outcome Measure Information:
Title
Low Density Lipoprotein
Description
this outcome measurement will be achieved by taking patient's blood sample after cardiac rehabilitation program
Time Frame
3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
Title
Body Mass Index
Description
Body Mass Index is calculated by calculating the measured body weight divided by the height square in measure. We take BMI data after cardiac rehabilitation program in every participant.
Time Frame
3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
Title
High-Density Lipoprotein
Description
this outcome measurement will be achieved by taking patient's blood sample after cardiac rehabilitation program
Time Frame
3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
Title
Total Cholesterol
Description
this outcome measurement will be achieved by taking patient's blood sample after cardiac rehabilitation program
Time Frame
3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
Title
Triglyceride
Description
This outcome measurement will be achieved by taking the patient's blood sample after cardiac rehabilitation program
Time Frame
3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
Title
Fasting Blood Glucose
Description
Blood glucose concentration was taken after 10-12-hour fasting. This outcome measurement will be achieved by taking the patient's blood sample after cardiac rehabilitation program
Time Frame
3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
Title
Systolic Blood Pressure
Description
this outcome measurement will be achieved by taking the patient's blood pressure after cardiac rehabilitation program
Time Frame
3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
Title
Diastolic Blood Pressure
Description
this outcome measurement will be achieved by taking the patient's blood pressure after cardiac rehabilitation program
Time Frame
3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
post elective coronary artery bypass surgery
> 18 years old
sign informed consent
Exclusion Criteria:
contraindications of resistance training (unstable angina, uncontrolled blood pressure (systolic > 160 mmHg diastolic > 100 mmHg), acute heart failure, pulmonary diseases, arrhythmia malignant)
musculoskeletal pain, visual analog scale >3
post congenital heart disease surgery
post elective coronary artery bypass surgery with malfunction valves (operated or not)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bambang Dwiputra, MD
Organizational Affiliation
National Cardiovascular Center Harapan Kita
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Links:
URL
http://www.pjnhk.go.id/
Description
website of hospital where the study protocol will be held
URL
http://www.ui.ac.id
Description
website of educational institution inside the hospital
Available IPD and Supporting Information:
Available IPD/Information Type
informed consent, research proposal, good clinical practice certificate, questioner (in one folder)
Available IPD/Information URL
https://drive.google.com/folderview?id=0Bzz_LouDZWOkU1FoTWh1bC1HNmM&usp=sharing
Available IPD/Information Comments
informed consent, research proposal, good clinical practice certificate, World health organization quality of life questioner (in one folder)
Learn more about this trial
The Effect of Resistance Training on Proprotein Subtilisin Convertase Kexin 9 Level After Coronary Bypass Surgery
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