The Effect of Resistance Training on Proprotein Subtilisin Convertase Kexin 9 Level After Coronary Bypass Surgery

January 7, 2020 updated by: Bambang Dwiputra, National Cardiovascular Center Harapan Kita Hospital Indonesia

The Effect of Resistance Training on Proprotein Subtilisin Convertase Kexin 9 (PCSK-9) Level in Patients After Coronary Bypass Surgery

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Not Applicable

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control group
Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program (aerobic training only)
Behavioral: aerobic training
aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)
Experimental: Intervention group
Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program plus resistance training (aerobic and resistance training as well)
Behavioral: aerobic training
aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)
Behavioral: resistance training
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PCSK-9 Level
Time Frame: 3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
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
3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Low Density Lipoprotein
Time Frame: 3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
this outcome measurement will be achieved by taking patient's blood sample after cardiac rehabilitation program
3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
Body Mass Index
Time Frame: 3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
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.
3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
High-Density Lipoprotein
Time Frame: 3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
this outcome measurement will be achieved by taking patient's blood sample after cardiac rehabilitation program
3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
Total Cholesterol
Time Frame: 3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
this outcome measurement will be achieved by taking patient's blood sample after cardiac rehabilitation program
3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
Triglyceride
Time Frame: 3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
This outcome measurement will be achieved by taking the patient's blood sample after cardiac rehabilitation program
3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
Fasting Blood Glucose
Time Frame: 3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
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
3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
Systolic Blood Pressure
Time Frame: 3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
this outcome measurement will be achieved by taking the patient's blood pressure after cardiac rehabilitation program
3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
Diastolic Blood Pressure
Time Frame: 3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
this outcome measurement will be achieved by taking the patient's blood pressure after cardiac rehabilitation program
3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cardiovascular Center Harapan Kita Hospital Indonesia

Investigators

  • Principal Investigator: Bambang Dwiputra, MD, National Cardiovascular Center Harapan Kita

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

Helpful Links

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)

February 10, 2016

Primary Completion (Actual)

September 23, 2016

Study Completion (Actual)

December 18, 2016

Study Registration Dates

First Submitted

February 2, 2016

First Submitted That Met QC Criteria

February 3, 2016

First Posted (Estimate)

February 4, 2016

Study Record Updates

Last Update Posted (Actual)

January 21, 2020

Last Update Submitted That Met QC Criteria

January 7, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RUHK-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. informed consent, research proposal, good clinical practice certificate, questioner (in one folder)
    Information comments: informed consent, research proposal, good clinical practice certificate, World health organization quality of life questioner (in one folder)

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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