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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
National Cardiovascular Center Harapan Kita Hospital Indonesia
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    February 2, 2016
    Last Updated
    January 7, 2020
    Sponsor
    National Cardiovascular Center Harapan Kita Hospital Indonesia
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    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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