NCT02674659

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)

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable coronary-artery-disease

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 4, 2016

Completed
6 days until next milestone

Study Start

First participant enrolled

February 10, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2016

Completed
3 years until next milestone

Results Posted

Study results publicly available

December 9, 2019

Completed
Last Updated

January 21, 2020

Status Verified

January 1, 2020

Enrollment Period

8 months

First QC Date

February 2, 2016

Results QC Date

November 19, 2019

Last Update Submit

January 7, 2020

Conditions

Coronary Artery Disease

Keywords

resistance training, PCSK9, coronary artery bypass grafting

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Low Density Lipoprotein

    3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)

  • Body Mass Index

    3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)

  • High-Density Lipoprotein

    3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)

  • Total Cholesterol

    3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)

  • Triglyceride

    3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)

  • +3 more secondary outcomes

Study Arms (2)

Control group

EXPERIMENTAL

Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program (aerobic training only)

Behavioral: aerobic training

Intervention group

EXPERIMENTAL

Patients after coronary bypass surgery who undergo conventional cardiac rehabilitation program plus resistance training (aerobic and resistance training as well)

Behavioral: resistance trainingBehavioral: aerobic training

Interventions

resistance trainingBEHAVIORAL

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 group
aerobic trainingBEHAVIORAL

aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)

Control groupIntervention group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • post elective coronary artery bypass surgery
  • \> 18 years old
  • sign informed consent

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (27)

  • 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. doi: 10.1016/j.amjmed.2004.01.009.

    PMID: 15121495BACKGROUND

  • 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.

    PMID: 21896934BACKGROUND

  • 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 Rehabil Med. 2013 Mar;56(2):85-101. doi: 10.1016/j.rehab.2012.10.006. Epub 2012 Dec 7.

    PMID: 23414745RESULT

  • 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. 2012 Dec;60(12):2270-6. doi: 10.1111/jgs.12030. Epub 2012 Nov 23.

    PMID: 23176104RESULT

  • 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 Aug 26.

    PMID: 26081791RESULT

  • Urban D, Poss J, Bohm 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.

    PMID: 23973703RESULT

  • 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 Lipid Therapy in Asia (REALITY-Asia) study. Curr Med Res Opin. 2008 Jul;24(7):1951-63. doi: 10.1185/03007990802138731. Epub 2008 Jun 10.

    PMID: 18547466RESULT

  • 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):2497-506. doi: 10.1001/jama.2012.25790.

    PMID: 23128163RESULT

  • 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. doi: 10.1056/NEJMoa054013.

    PMID: 16554528RESULT

  • 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. doi: 10.1172/JCI29383.

    PMID: 17080197RESULT

  • 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 increases degradation. J Biol Chem. 2007 Jun 22;282(25):18602-18612. doi: 10.1074/jbc.M702027200. Epub 2007 Apr 23.

    PMID: 17452316RESULT

  • 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.

    PMID: 23862065RESULT

  • European Association of Cardiovascular Prevention and Rehabilitation Committee for Science Guidelines; EACPR; Corra U, Piepoli MF, Carre F, Heuschmann P, Hoffmann U, Verschuren M, Halcox J; Document Reviewers; Giannuzzi P, Saner H, Wood D, Piepoli MF, Corra U, Benzer W, Bjarnason-Wehrens B, Dendale P, Gaita D, McGee H, Mendes M, Niebauer J, Zwisler AD, Schmid JP. Secondary prevention through cardiac rehabilitation: physical activity counselling and exercise training: key components of the position paper from the Cardiac Rehabilitation Section of the European Association of Cardiovascular Prevention and Rehabilitation. Eur Heart J. 2010 Aug;31(16):1967-74. doi: 10.1093/eurheartj/ehq236. Epub 2010 Jul 19.

    PMID: 20643803RESULT

  • 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. doi: 10.1016/j.ejcts.2007.08.013. Epub 2007 Sep 18.

    PMID: 17881241RESULT

  • 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. 2017 Feb;31(1):26-31. doi: 10.1053/j.jvca.2016.08.004. Epub 2016 Aug 4.

    PMID: 27771273RESULT

  • Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Despres 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, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2015 update: a report from the American Heart Association. Circulation. 2015 Jan 27;131(4):e29-322. doi: 10.1161/CIR.0000000000000152. Epub 2014 Dec 17. No abstract available.

    PMID: 25520374RESULT

  • 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. doi: 10.1186/s12871-016-0271-5.

    PMID: 27760527RESULT

  • Abifadel M, Varret M, Rabes JP, Allard D, Ouguerram K, Devillers M, Cruaud C, Benjannet S, Wickham L, Erlich D, Derre A, Villeger L, Farnier M, Beucler I, Bruckert E, Chambaz J, Chanu B, Lecerf JM, Luc G, Moulin P, Weissenbach J, Prat A, Krempf M, Junien C, Seidah NG, Boileau C. Mutations in PCSK9 cause autosomal dominant hypercholesterolemia. Nat Genet. 2003 Jun;34(2):154-6. doi: 10.1038/ng1161.

    PMID: 12730697RESULT

  • 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. doi: 10.1194/jlr.M700437-JLR200. Epub 2007 Nov 21.

    PMID: 18033751RESULT

  • Boyer M, Levesque V, Poirier P, Marette A, Mathieu P, Despres JP, Larose E, 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-Dec;10(6):1353-1361. doi: 10.1016/j.jacl.2016.08.014. Epub 2016 Sep 2.

    PMID: 27919352RESULT

  • 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: 10.1373/clinchem.2009.126987. Epub 2009 Jul 23.

    PMID: 19628659RESULT

  • 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. doi: 10.1152/japplphysiol.01161.2002. Epub 2003 Aug 22.

    PMID: 12937035RESULT

  • 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. doi: 10.7150/ijms.4.19.

    PMID: 17211497RESULT

  • Arsenault BJ, Pelletier-Beaumont E, Almeras N, Tremblay A, Poirier P, Bergeron J, Despres JP. PCSK9 levels in abdominally obese men: association with cardiometabolic risk profile and effects of a one-year lifestyle modification program. Atherosclerosis. 2014 Oct;236(2):321-6. doi: 10.1016/j.atherosclerosis.2014.07.010. Epub 2014 Jul 26.

    PMID: 25128757RESULT

  • 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. doi: 10.1249/01.mss.0000227304.88406.0f.

    PMID: 16826016RESULT

  • 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. doi: 10.1161/01.hyp.35.3.838.

    PMID: 10720604RESULT

  • Dwiputra B, Santoso A, Purwowiyoto BS, Radi B, Ambari AM. The effect of resistance training on PCSK9 levels in patients undergoing cardiac rehabilitation after coronary artery bypass grafting: a randomized study. BMC Cardiovasc Disord. 2023 Nov 9;23(1):549. doi: 10.1186/s12872-023-03571-7.

    PMID: 37946122DERIVED

Related Links

MeSH Terms

Conditions

Coronary Artery DiseaseHypercholesterolemia, Autosomal Dominant, 3

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

This study only investigated selected population of patients (post CABG patients) and cannot explain further the mechanism of reduced PCSK9 level by doing resistance training

Results Point of Contact

Title
Bambang Dwiputra, MD, FIHA
Organization
Harapan Kita National Cardiovascular Center
bambangdwiputra@gmail.com
0215684093

Study Officials

  • Bambang Dwiputra, MD

    National Cardiovascular Center Harapan Kita

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 2, 2016

First Posted

February 4, 2016

Study Start

February 10, 2016

Primary Completion

September 23, 2016

Study Completion

December 18, 2016

Last Updated

January 21, 2020

Results First Posted

December 9, 2019

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share