Trial Outcomes & Findings for The Effect of Resistance Training on Proprotein Subtilisin Convertase Kexin 9 Level After Coronary Bypass Surgery (NCT NCT02674659)
NCT ID: NCT02674659
Last Updated: 2020-01-21
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
87 participants
Primary outcome timeframe
3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
Results posted on
2020-01-21
Participant Flow
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.
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.
Participant milestones
| Measure |
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)
|
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)
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
44
|
|
Overall Study
COMPLETED
|
39
|
40
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CABG patients on pump (using CPB machine)
Baseline characteristics by cohort
| Measure |
Control Group
n=43 Participants
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)
|
Intervention Group
n=44 Participants
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)
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age
|
57.2 years old
STANDARD_DEVIATION 8.4 • n=43 Participants
|
56.3 years old
STANDARD_DEVIATION 8.1 • n=44 Participants
|
56.8 years old
STANDARD_DEVIATION 8.3 • n=87 Participants
|
|
Sex/Gender, Customized
Sex : Sex
|
43 Participants
n=43 Participants
|
44 Participants
n=44 Participants
|
87 Participants
n=87 Participants
|
|
Sex/Gender, Customized
Sex : Male
|
38 Participants
n=43 Participants
|
39 Participants
n=44 Participants
|
77 Participants
n=87 Participants
|
|
Sex/Gender, Customized
Sex : Female
|
5 Participants
n=43 Participants
|
5 Participants
n=44 Participants
|
10 Participants
n=87 Participants
|
|
Height
|
164.5 cm
STANDARD_DEVIATION 6.8 • n=43 Participants
|
162.9 cm
STANDARD_DEVIATION 6.4 • n=44 Participants
|
163.7 cm
STANDARD_DEVIATION 6.6 • n=87 Participants
|
|
weight
|
68.2 kg
STANDARD_DEVIATION 10.6 • n=43 Participants
|
65.9 kg
STANDARD_DEVIATION 10.9 • n=44 Participants
|
67.1 kg
STANDARD_DEVIATION 10.8 • n=87 Participants
|
|
waist circumference
|
97.5 cm
STANDARD_DEVIATION 10.5 • n=43 Participants
|
95.1 cm
STANDARD_DEVIATION 10.8 • n=44 Participants
|
96.3 cm
STANDARD_DEVIATION 10.7 • n=87 Participants
|
|
Body Mass Index
|
25.2 kg/m^2
STANDARD_DEVIATION 2.9 • n=43 Participants
|
24.6 kg/m^2
STANDARD_DEVIATION 3.1 • n=44 Participants
|
24.9 kg/m^2
STANDARD_DEVIATION 3 • n=87 Participants
|
|
Cardiovascular risk factor
Hypertension
|
32 Participants
n=43 Participants
|
31 Participants
n=44 Participants
|
63 Participants
n=87 Participants
|
|
Cardiovascular risk factor
Diabetes Mellitus
|
20 Participants
n=43 Participants
|
21 Participants
n=44 Participants
|
41 Participants
n=87 Participants
|
|
Cardiovascular risk factor
Dyslipidemia
|
21 Participants
n=43 Participants
|
21 Participants
n=44 Participants
|
42 Participants
n=87 Participants
|
|
Cardiovascular risk factor
Smoking
|
32 Participants
n=43 Participants
|
33 Participants
n=44 Participants
|
65 Participants
n=87 Participants
|
|
Cardiovascular risk factor
Family history
|
6 Participants
n=43 Participants
|
8 Participants
n=44 Participants
|
14 Participants
n=87 Participants
|
|
Ejection Fraction
|
52.1 %
STANDARD_DEVIATION 15.2 • n=43 Participants
|
50.2 %
STANDARD_DEVIATION 15.4 • n=44 Participants
|
51.1 %
STANDARD_DEVIATION 15.3 • n=87 Participants
|
|
Systolic Blood Pressure
|
121.1 mmHg
STANDARD_DEVIATION 14.8 • n=43 Participants
|
125.3 mmHg
STANDARD_DEVIATION 17.9 • n=44 Participants
|
123.2 mmHg
STANDARD_DEVIATION 16.4 • n=87 Participants
|
|
Diastolic Blood Pressure
|
74.5 mmHg
STANDARD_DEVIATION 9.8 • n=43 Participants
|
76.8 mmHg
STANDARD_DEVIATION 9.9 • n=44 Participants
|
75.7 mmHg
STANDARD_DEVIATION 9.9 • n=87 Participants
|
|
Statin therapy
Simvastatin
|
32 Participants
n=43 Participants
|
33 Participants
n=44 Participants
|
65 Participants
n=87 Participants
|
|
Statin therapy
Simvastatin 10 mg
|
4 Participants
n=43 Participants
|
3 Participants
n=44 Participants
|
7 Participants
n=87 Participants
|
|
Statin therapy
Simvastatin 20 mg
|
28 Participants
n=43 Participants
|
30 Participants
n=44 Participants
|
58 Participants
n=87 Participants
|
|
Statin therapy
Atorvastatin
|
11 Participants
n=43 Participants
|
11 Participants
n=44 Participants
|
22 Participants
n=87 Participants
|
|
Length of stay
|
9.1 days
STANDARD_DEVIATION 4.0 • n=43 Participants
|
9.1 days
STANDARD_DEVIATION 3.9 • n=44 Participants
|
9.1 days
STANDARD_DEVIATION 4.0 • n=87 Participants
|
|
CPB duration
|
81.5 minutes
STANDARD_DEVIATION 26.4 • n=38 Participants • CABG patients on pump (using CPB machine)
|
81.2 minutes
STANDARD_DEVIATION 21.3 • n=40 Participants • CABG patients on pump (using CPB machine)
|
81.4 minutes
STANDARD_DEVIATION 23.9 • n=78 Participants • CABG patients on pump (using CPB machine)
|
|
Aortic cross clamp duration
|
48.9 minutes
STANDARD_DEVIATION 24.1 • n=38 Participants • CABG patients on pump (using CPB machine)
|
47.6 minutes
STANDARD_DEVIATION 16.9 • n=40 Participants • CABG patients on pump (using CPB machine)
|
48.3 minutes
STANDARD_DEVIATION 20.5 • n=78 Participants • CABG patients on pump (using CPB machine)
|
|
Cardiac Rehabilitation Program Type
Frequency 3 times/week
|
18 Participants
n=43 Participants
|
20 Participants
n=44 Participants
|
38 Participants
n=87 Participants
|
|
Cardiac Rehabilitation Program Type
Frequency 5 times/week
|
25 Participants
n=43 Participants
|
24 Participants
n=44 Participants
|
49 Participants
n=87 Participants
|
|
Fasting Blood Glucose
|
116.5 mg/dL
STANDARD_DEVIATION 41.5 • n=43 Participants
|
116.6 mg/dL
STANDARD_DEVIATION 37.6 • n=44 Participants
|
116.6 mg/dL
STANDARD_DEVIATION 39.6 • n=87 Participants
|
|
Lipid profile
Total Cholesterol
|
161.1 mg/dL
STANDARD_DEVIATION 32.4 • n=43 Participants
|
160.4 mg/dL
STANDARD_DEVIATION 36.5 • n=44 Participants
|
160.8 mg/dL
STANDARD_DEVIATION 34.5 • n=87 Participants
|
|
Lipid profile
High Density Lipoprotein
|
32.9 mg/dL
STANDARD_DEVIATION 8.5 • n=43 Participants
|
34.5 mg/dL
STANDARD_DEVIATION 8.0 • n=44 Participants
|
33.7 mg/dL
STANDARD_DEVIATION 8.3 • n=87 Participants
|
|
Lipid profile
Low Density Lipoprotein
|
96.7 mg/dL
STANDARD_DEVIATION 30.1 • n=43 Participants
|
96.3 mg/dL
STANDARD_DEVIATION 30.2 • n=44 Participants
|
96.5 mg/dL
STANDARD_DEVIATION 30.2 • n=87 Participants
|
|
Lipid profile
Trigliseride
|
172.2 mg/dL
STANDARD_DEVIATION 63.2 • n=43 Participants
|
171.8 mg/dL
STANDARD_DEVIATION 58.7 • n=44 Participants
|
172 mg/dL
STANDARD_DEVIATION 70 • n=87 Participants
|
|
Aspartate Aminotransferase (AST)
|
24.6 mg/dL
STANDARD_DEVIATION 16.5 • n=43 Participants
|
28.8 mg/dL
STANDARD_DEVIATION 16.6 • n=44 Participants
|
26.7 mg/dL
STANDARD_DEVIATION 16.6 • n=87 Participants
|
|
Alanine Aminotransferase (ALT)
|
44.3 mg/dL
STANDARD_DEVIATION 23.3 • n=43 Participants
|
49.2 mg/dL
STANDARD_DEVIATION 24.2 • n=44 Participants
|
46.8 mg/dL
STANDARD_DEVIATION 23.8 • n=87 Participants
|
|
Uric acid
|
7.1 mg/dL
STANDARD_DEVIATION 1.1 • n=43 Participants
|
7.1 mg/dL
STANDARD_DEVIATION 1.6 • n=44 Participants
|
7.1 mg/dL
STANDARD_DEVIATION 1.4 • n=87 Participants
|
|
Creatinine
|
1.07 mg/dL
STANDARD_DEVIATION 0.3 • n=43 Participants
|
1.03 mg/dL
STANDARD_DEVIATION 0.2 • n=44 Participants
|
1.05 mg/dL
STANDARD_DEVIATION 0.3 • n=87 Participants
|
|
PCSK-9
|
382.4 ng/ml
STANDARD_DEVIATION 127.3 • n=43 Participants
|
407.04 ng/ml
STANDARD_DEVIATION 112.3 • n=44 Participants
|
394.7 ng/ml
STANDARD_DEVIATION 119.8 • n=87 Participants
|
PRIMARY outcome
Timeframe: 3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)Population: Patients who completed the 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
Outcome measures
| Measure |
Control Group
n=39 Participants
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)
|
Intervention Group
n=40 Participants
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)
|
|---|---|---|
|
PCSK-9 Level
|
377.5 ng/ml
Standard Deviation 118.9
|
322.53 ng/ml
Standard Deviation 107.5
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Control Group
n=43 Participants
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)
|
Intervention Group
n=44 Participants
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)
|
|---|---|---|
|
Low Density Lipoprotein
|
106.3 mg/dL
Standard Deviation 26.6
|
96.2 mg/dL
Standard Deviation 24.9
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Control Group
n=43 Participants
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)
|
Intervention Group
n=44 Participants
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)
|
|---|---|---|
|
Body Mass Index
|
25.3 kg/m^2
Standard Deviation 2.9
|
24.7 kg/m^2
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Control Group
n=43 Participants
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)
|
Intervention Group
n=44 Participants
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)
|
|---|---|---|
|
High-Density Lipoprotein
|
36.1 mg/dL
Standard Deviation 7.0
|
37.4 mg/dL
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Control Group
n=43 Participants
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)
|
Intervention Group
n=44 Participants
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)
|
|---|---|---|
|
Total Cholesterol
|
162.2 mg/dL
Standard Deviation 32.6
|
162.1 mg/dL
Standard Deviation 35.5
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Control Group
n=43 Participants
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)
|
Intervention Group
n=44 Participants
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)
|
|---|---|---|
|
Triglyceride
|
145.7 mg/dL
Standard Deviation 50.2
|
139.4 mg/dL
Standard Deviation 50.7
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Control Group
n=43 Participants
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)
|
Intervention Group
n=44 Participants
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)
|
|---|---|---|
|
Fasting Blood Glucose
|
107.7 mg/dL
Standard Deviation 24.6
|
102.4 mg/dL
Standard Deviation 22.9
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Control Group
n=43 Participants
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)
|
Intervention Group
n=44 Participants
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)
|
|---|---|---|
|
Systolic Blood Pressure
|
117.3 mmHg
Standard Deviation 11.4
|
118.8 mmHg
Standard Deviation 12.5
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Control Group
n=43 Participants
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)
|
Intervention Group
n=44 Participants
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)
|
|---|---|---|
|
Diastolic Blood Pressure
|
73.8 mmHg
Standard Deviation 6.3
|
74.8 mmHg
Standard Deviation 10.3
|
Adverse Events
Control Group
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Intervention Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control Group
n=43 participants at risk
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)
|
Intervention Group
n=44 participants at risk
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)
|
|---|---|---|
|
Cardiac disorders
Acute heart failure
|
2.3%
1/43 • Number of events 1 • 2 months
|
2.3%
1/44 • Number of events 1 • 2 months
|
Other adverse events
| Measure |
Control Group
n=43 participants at risk
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)
|
Intervention Group
n=44 participants at risk
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)
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
wound infection
|
4.7%
2/43 • Number of events 2 • 2 months
|
0.00%
0/44 • 2 months
|
Additional Information
Bambang Dwiputra, MD, FIHA
Harapan Kita National Cardiovascular Center
Phone: 0215684093
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place