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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02674659
• Other study ID #: RUHK-2016
• Status: Completed
• Phase: N/A
• Start date: February 10, 2016
• Est. completion date: December 18, 2016

Study information

• Verified date: January 2020
• Source: National Cardiovascular Center Harapan Kita Hospital Indonesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: December 18, 2016
• Est. primary completion date: September 23, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

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.
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Cardiovascular Center Harapan Kita Hospital Indonesia

References & Publications (26)

Abifadel M, Varret M, Rabès JP, Allard D, Ouguerram K, Devillers M, Cruaud C, Benjannet S, Wickham L, Erlich D, Derré A, Villéger L, Farnier M, Beucler I, Bruckert E, Chambaz J, Chanu B, Lecerf JM, Luc G, Moulin P, Weissenbach J, Prat A, Krempf M, Junien — View Citation

Arsenault BJ, Pelletier-Beaumont E, Alméras N, Tremblay A, Poirier P, Bergeron J, Després JP. PCSK9 levels in abdominally obese men: association with cardiometabolic risk profile and effects of a one-year lifestyle modification program. Atherosclerosis. 2 — View Citation

Baass A, Dubuc G, Tremblay M, Delvin EE, O'Loughlin J, Levy E, Davignon J, Lambert M. Plasma PCSK9 is associated with age, sex, and multiple metabolic markers in a population-based sample of children and adolescents. Clin Chem. 2009 Sep;55(9):1637-45. doi — View Citation

Boyer M, Lévesque V, Poirier P, Marette A, Mathieu P, Després JP, Larose É, Arsenault BJ. Impact of a 1-year lifestyle modification program on plasma lipoprotein and PCSK9 concentrations in patients with coronary artery disease. J Clin Lipidol. 2016 Nov - — View Citation

Brooks N, Layne JE, Gordon PL, Roubenoff R, Nelson ME, Castaneda-Sceppa C. Strength training improves muscle quality and insulin sensitivity in Hispanic older adults with type 2 diabetes. Int J Med Sci. 2006 Dec 18;4(1):19-27. — View Citation

Busch JC, Lillou D, Wittig G, Bartsch P, Willemsen D, Oldridge N, Bjarnason-Wehrens B. Resistance and balance training improves functional capacity in very old participants attending cardiac rehabilitation after coronary bypass surgery. J Am Geriatr Soc. — View Citation

Careskey HE, Davis RA, Alborn WE, Troutt JS, Cao G, Konrad RJ. Atorvastatin increases human serum levels of proprotein convertase subtilisin/kexin type 9. J Lipid Res. 2008 Feb;49(2):394-8. Epub 2007 Nov 21. — View Citation

Chen YW, Hubal MJ, Hoffman EP, Thompson PD, Clarkson PM. Molecular responses of human muscle to eccentric exercise. J Appl Physiol (1985). 2003 Dec;95(6):2485-94. Epub 2003 Aug 22. — View Citation

Cohen JC, Boerwinkle E, Mosley TH Jr, Hobbs HH. Sequence variations in PCSK9, low LDL, and protection against coronary heart disease. N Engl J Med. 2006 Mar 23;354(12):1264-72. — View Citation

Cornelissen VA, Fagard RH, Coeckelberghs E, Vanhees L. Impact of resistance training on blood pressure and other cardiovascular risk factors: a meta-analysis of randomized, controlled trials. Hypertension. 2011 Nov;58(5):950-8. doi: 10.1161/HYPERTENSIONAHA.111.177071. Epub 2011 Sep 6. Review. — View Citation

European Association of Cardiovascular Prevention and Rehabilitation Committee for Science Guidelines; EACPR, Corrà U, Piepoli MF, Carré F, Heuschmann P, Hoffmann U, Verschuren M, Halcox J; Document Reviewers, Giannuzzi P, Saner H, Wood D, Piepoli MF, Cor — View Citation

Fiorina C, Vizzardi E, Lorusso R, Maggio M, De Cicco G, Nodari S, Faggiano P, Dei Cas L. The 6-min walking test early after cardiac surgery. Reference values and the effects of rehabilitation programme. Eur J Cardiothorac Surg. 2007 Nov;32(5):724-9. Epub — View Citation

Ghroubi S, Elleuch W, Abid L, Abdenadher M, Kammoun S, Elleuch MH. Effects of a low-intensity dynamic-resistance training protocol using an isokinetic dynamometer on muscular strength and aerobic capacity after coronary artery bypass grafting. Ann Phys Re — View Citation

Kamani CH, Gencer B, Montecucco F, Courvoisier D, Vuilleumier N, Meyer P, Mach F. Stairs instead of elevators at the workplace decreases PCSK9 levels in a healthy population. Eur J Clin Invest. 2015 Oct;45(10):1017-24. doi: 10.1111/eci.12480. Epub 2015 Au — View Citation

Kelley GA, Kelley KS. Progressive resistance exercise and resting blood pressure : A meta-analysis of randomized controlled trials. Hypertension. 2000 Mar;35(3):838-43. — View Citation

Kim HS, Wu Y, Lin SJ, Deerochanawong C, Zambahari R, Zhao L, Zhang Q, Yan P. Current status of cholesterol goal attainment after statin therapy among patients with hypercholesterolemia in Asian countries and region: the Return on Expenditure Achieved for — View Citation

Lagace TA, Curtis DE, Garuti R, McNutt MC, Park SW, Prather HB, Anderson NN, Ho YK, Hammer RE, Horton JD. Secreted PCSK9 decreases the number of LDL receptors in hepatocytes and in livers of parabiotic mice. J Clin Invest. 2006 Nov;116(11):2995-3005. — View Citation

Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Després JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, — View Citation

Pieri M, Belletti A, Monaco F, Pisano A, Musu M, Dalessandro V, Monti G, Finco G, Zangrillo A, Landoni G. Outcome of cardiac surgery in patients with low preoperative ejection fraction. BMC Anesthesiol. 2016 Oct 18;16(1):97. — View Citation

Shaibi GQ, Cruz ML, Ball GD, Weigensberg MJ, Salem GJ, Crespo NC, Goran MI. Effects of resistance training on insulin sensitivity in overweight Latino adolescent males. Med Sci Sports Exerc. 2006 Jul;38(7):1208-15. — View Citation

Sullivan D, Olsson AG, Scott R, Kim JB, Xue A, Gebski V, Wasserman SM, Stein EA. Effect of a monoclonal antibody to PCSK9 on low-density lipoprotein cholesterol levels in statin-intolerant patients: the GAUSS randomized trial. JAMA. 2012 Dec 19;308(23):24 — View Citation

Taylor RS, Brown A, Ebrahim S, Jolliffe J, Noorani H, Rees K, Skidmore B, Stone JA, Thompson DR, Oldridge N. Exercise-based rehabilitation for patients with coronary heart disease: systematic review and meta-analysis of randomized controlled trials. Am J Med. 2004 May 15;116(10):682-92. Review. — View Citation

Urban D, Pöss J, Böhm M, Laufs U. Targeting the proprotein convertase subtilisin/kexin type 9 for the treatment of dyslipidemia and atherosclerosis. J Am Coll Cardiol. 2013 Oct 15;62(16):1401-8. doi: 10.1016/j.jacc.2013.07.056. Epub 2013 Aug 21. Review. — View Citation

Wang J, Yu W, Zhao D, Liu N, Yu Y. In-Hospital and Long-Term Mortality in 35,173 Chinese Patients Undergoing Coronary Artery Bypass Grafting in Beijing: Impact of Sex, Age, Myocardial Infarction, and Cardiopulmonary Bypass. J Cardiothorac Vasc Anesth. 201 — View Citation

Wen S, Jadhav KS, Williamson DL, Rideout TC. Treadmill Exercise Training Modulates Hepatic Cholesterol Metabolism and Circulating PCSK9 Concentration in High-Fat-Fed Mice. J Lipids. 2013;2013:908048. doi: 10.1155/2013/908048. Epub 2013 Jun 19. — View Citation

Zhang DW, Lagace TA, Garuti R, Zhao Z, McDonald M, Horton JD, Cohen JC, Hobbs HH. Binding of proprotein convertase subtilisin/kexin type 9 to epidermal growth factor-like repeat A of low density lipoprotein receptor decreases receptor recycling and increa — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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	3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
Secondary	Low Density Lipoprotein	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)
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.	3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
Secondary	High-Density Lipoprotein	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)
Secondary	Total Cholesterol	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)
Secondary	Triglyceride	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)
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	3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)
Secondary	Systolic Blood Pressure	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)
Secondary	Diastolic Blood Pressure	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)

External Links

•   website of educational institution inside the hospital
•   website of hospital where the study protocol will be held