Coronary Artery Disease
Conditions
Keywords
resistance training, PCSK9, coronary artery bypass grafting
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.
Interventions
BEHAVIORALresistance 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.
BEHAVIORALaerobic training
aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)
Sponsors
National Cardiovascular Center Harapan Kita Hospital Indonesia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PCSK-9 Level | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index | 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. |
| High-Density Lipoprotein | 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 |
| Total Cholesterol | 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 |
| Low Density Lipoprotein | 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 |
| Fasting Blood Glucose | 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 |
| Systolic Blood Pressure | 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 |
| Diastolic Blood Pressure | 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 |
| Triglyceride | 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 |
Participant flow
Recruitment details
We initiate this project from February 10th, 2016 until September 23rd, 2016. All the subjects (post coronary artery bypass graft operation) were collected from the National Cardiovascular Center Harapan Kita.
Pre-assignment details
There is no specific run-in period for every patient enrolled in this study. If they meet the inclusion criteria, they will be randomly assigned to the intervention or control group.
Participants by arm
| Arm | Count |
|---|---|
| Control Group Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program (aerobic training only)
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) | 43 |
| Intervention Group Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program plus resistance training (aerobic and resistance training as well)
resistance training: resistance training consists of lower and upper extremities exercises. We focus on biceps and hamstring to be trained. One session will be held for around 15 minutes.
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) | 44 |
| Total | 87 |
Baseline characteristics
| Characteristic | Total | Intervention Group | Control Group |
|---|---|---|---|
| Age, Customized Age | 56.8 years old STANDARD_DEVIATION 8.3 | 56.3 years old STANDARD_DEVIATION 8.1 | 57.2 years old STANDARD_DEVIATION 8.4 |
| Alanine Aminotransferase (ALT) | 46.8 mg/dL STANDARD_DEVIATION 23.8 | 49.2 mg/dL STANDARD_DEVIATION 24.2 | 44.3 mg/dL STANDARD_DEVIATION 23.3 |
| Aortic cross clamp duration | 48.3 minutes STANDARD_DEVIATION 20.5 | 47.6 minutes STANDARD_DEVIATION 16.9 | 48.9 minutes STANDARD_DEVIATION 24.1 |
| Aspartate Aminotransferase (AST) | 26.7 mg/dL STANDARD_DEVIATION 16.6 | 28.8 mg/dL STANDARD_DEVIATION 16.6 | 24.6 mg/dL STANDARD_DEVIATION 16.5 |
| Body Mass Index | 24.9 kg/m^2 STANDARD_DEVIATION 3 | 24.6 kg/m^2 STANDARD_DEVIATION 3.1 | 25.2 kg/m^2 STANDARD_DEVIATION 2.9 |
| Cardiac Rehabilitation Program Type Frequency 3 times/week | 38 Participants | 20 Participants | 18 Participants |
| Cardiac Rehabilitation Program Type Frequency 5 times/week | 49 Participants | 24 Participants | 25 Participants |
| Cardiovascular risk factor Diabetes Mellitus | 41 Participants | 21 Participants | 20 Participants |
| Cardiovascular risk factor Dyslipidemia | 42 Participants | 21 Participants | 21 Participants |
| Cardiovascular risk factor Family history | 14 Participants | 8 Participants | 6 Participants |
| Cardiovascular risk factor Hypertension | 63 Participants | 31 Participants | 32 Participants |
| Cardiovascular risk factor Smoking | 65 Participants | 33 Participants | 32 Participants |
| CPB duration | 81.4 minutes STANDARD_DEVIATION 23.9 | 81.2 minutes STANDARD_DEVIATION 21.3 | 81.5 minutes STANDARD_DEVIATION 26.4 |
| Creatinine | 1.05 mg/dL STANDARD_DEVIATION 0.3 | 1.03 mg/dL STANDARD_DEVIATION 0.2 | 1.07 mg/dL STANDARD_DEVIATION 0.3 |
| Diastolic Blood Pressure | 75.7 mmHg STANDARD_DEVIATION 9.9 | 76.8 mmHg STANDARD_DEVIATION 9.9 | 74.5 mmHg STANDARD_DEVIATION 9.8 |
| Ejection Fraction | 51.1 % STANDARD_DEVIATION 15.3 | 50.2 % STANDARD_DEVIATION 15.4 | 52.1 % STANDARD_DEVIATION 15.2 |
| Fasting Blood Glucose | 116.6 mg/dL STANDARD_DEVIATION 39.6 | 116.6 mg/dL STANDARD_DEVIATION 37.6 | 116.5 mg/dL STANDARD_DEVIATION 41.5 |
| Height | 163.7 cm STANDARD_DEVIATION 6.6 | 162.9 cm STANDARD_DEVIATION 6.4 | 164.5 cm STANDARD_DEVIATION 6.8 |
| Length of stay | 9.1 days STANDARD_DEVIATION 4 | 9.1 days STANDARD_DEVIATION 3.9 | 9.1 days STANDARD_DEVIATION 4 |
| Lipid profile High Density Lipoprotein | 33.7 mg/dL STANDARD_DEVIATION 8.3 | 34.5 mg/dL STANDARD_DEVIATION 8 | 32.9 mg/dL STANDARD_DEVIATION 8.5 |
| Lipid profile Low Density Lipoprotein | 96.5 mg/dL STANDARD_DEVIATION 30.2 | 96.3 mg/dL STANDARD_DEVIATION 30.2 | 96.7 mg/dL STANDARD_DEVIATION 30.1 |
| Lipid profile Total Cholesterol | 160.8 mg/dL STANDARD_DEVIATION 34.5 | 160.4 mg/dL STANDARD_DEVIATION 36.5 | 161.1 mg/dL STANDARD_DEVIATION 32.4 |
| Lipid profile Trigliseride | 172 mg/dL STANDARD_DEVIATION 70 | 171.8 mg/dL STANDARD_DEVIATION 58.7 | 172.2 mg/dL STANDARD_DEVIATION 63.2 |
| PCSK-9 | 394.7 ng/ml STANDARD_DEVIATION 119.8 | 407.04 ng/ml STANDARD_DEVIATION 112.3 | 382.4 ng/ml STANDARD_DEVIATION 127.3 |
| Sex/Gender, Customized Sex : Female | 10 Participants | 5 Participants | 5 Participants |
| Sex/Gender, Customized Sex : Male | 77 Participants | 39 Participants | 38 Participants |
| Sex/Gender, Customized Sex : Sex | 87 Participants | 44 Participants | 43 Participants |
| Statin therapy Atorvastatin | 22 Participants | 11 Participants | 11 Participants |
| Statin therapy Simvastatin | 65 Participants | 33 Participants | 32 Participants |
| Statin therapy Simvastatin 10 mg | 7 Participants | 3 Participants | 4 Participants |
| Statin therapy Simvastatin 20 mg | 58 Participants | 30 Participants | 28 Participants |
| Systolic Blood Pressure | 123.2 mmHg STANDARD_DEVIATION 16.4 | 125.3 mmHg STANDARD_DEVIATION 17.9 | 121.1 mmHg STANDARD_DEVIATION 14.8 |
| Uric acid | 7.1 mg/dL STANDARD_DEVIATION 1.4 | 7.1 mg/dL STANDARD_DEVIATION 1.6 | 7.1 mg/dL STANDARD_DEVIATION 1.1 |
| waist circumference | 96.3 cm STANDARD_DEVIATION 10.7 | 95.1 cm STANDARD_DEVIATION 10.8 | 97.5 cm STANDARD_DEVIATION 10.5 |
| weight | 67.1 kg STANDARD_DEVIATION 10.8 | 65.9 kg STANDARD_DEVIATION 10.9 | 68.2 kg STANDARD_DEVIATION 10.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 44 |
| other Total, other adverse events | 2 / 43 | 0 / 44 |
| serious Total, serious adverse events | 1 / 43 | 1 / 44 |
Outcome results
Primary
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
Time frame: 3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
Population: Patients who completed the cardiac rehabilitation program
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | PCSK-9 Level | 377.5 ng/ml | Standard Deviation 118.9 |
| Intervention Group | PCSK-9 Level | 322.53 ng/ml | Standard Deviation 107.5 |
Secondary
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.
Time frame: 3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Body Mass Index | 25.3 kg/m^2 | Standard Deviation 2.9 |
| Intervention Group | Body Mass Index | 24.7 kg/m^2 | Standard Deviation 3 |
Secondary
Diastolic Blood Pressure
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Diastolic Blood Pressure | 73.8 mmHg | Standard Deviation 6.3 |
| Intervention Group | Diastolic Blood Pressure | 74.8 mmHg | Standard Deviation 10.3 |
Secondary
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
Time frame: 3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Fasting Blood Glucose | 107.7 mg/dL | Standard Deviation 24.6 |
| Intervention Group | Fasting Blood Glucose | 102.4 mg/dL | Standard Deviation 22.9 |
Secondary
High-Density Lipoprotein
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | High-Density Lipoprotein | 36.1 mg/dL | Standard Deviation 7 |
| Intervention Group | High-Density Lipoprotein | 37.4 mg/dL | Standard Deviation 7.9 |
Secondary
Low Density Lipoprotein
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Low Density Lipoprotein | 106.3 mg/dL | Standard Deviation 26.6 |
| Intervention Group | Low Density Lipoprotein | 96.2 mg/dL | Standard Deviation 24.9 |
Secondary
Systolic Blood Pressure
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Systolic Blood Pressure | 117.3 mmHg | Standard Deviation 11.4 |
| Intervention Group | Systolic Blood Pressure | 118.8 mmHg | Standard Deviation 12.5 |
Secondary
Total Cholesterol
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Total Cholesterol | 162.2 mg/dL | Standard Deviation 32.6 |
| Intervention Group | Total Cholesterol | 162.1 mg/dL | Standard Deviation 35.5 |
Secondary
Triglyceride
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Triglyceride | 145.7 mg/dL | Standard Deviation 50.2 |
| Intervention Group | Triglyceride | 139.4 mg/dL | Standard Deviation 50.7 |