Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatments resistance training, aerobic training
Phase phase 3
Sponsor National Cardiovascular Center Harapan Kita Hospital Indonesia
Start date February 2016
End date August 2016
Trial size 78 participants
Trial identifier NCT02674659, RUHK-2016

Summary

This research will 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)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose prevention
Arm
(Experimental)
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)
(Experimental)
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)

Primary Outcomes

Measure
PCSK-9 level
time frame: 2-4 weeks (after completion of 10-12 sessions of cardiac rehabilitation phase II)

Secondary Outcomes

Measure
low density lipoprotein (LDL) level
time frame: 2-4 weeks (after completion of 10-12 sessions of cardiac rehabilitation phase II)
quality of life
time frame: 2-4 weeks (after completion of 10-12 sessions of cardiac rehabilitation phase II)
oxygen consumption
time frame: 2-4 weeks (after completion of 10-12 sessions of cardiac rehabilitation phase II)

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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 diastolic > 100), 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)

Additional Information

Official title The Effect of Resistance Training on Proprotein Subtilisin Convertase Kexin 9 (PCSK-9) Level in Patients After Coronary Bypass Surgery
Principal investigator Bambang Dwiputra, MD
Description The PCSK9 level will be measured before and after cardiac rehabilitation program (around 2-4 weeks), and will be 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 Cardiac Center Harapan Kita, following rules from American College of Sports Medicine guideline regarding to exercise after cardiac event.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by National Cardiovascular Center Harapan Kita Hospital Indonesia.