Influence of Different Forms of Exercise Training in Patients With Coronary Artery Disease

NCT02831829 | Completed DMC

• 1 other identifier: UKCLRehab0012016
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of the study is to compare the effect of water-based and land-based exercise training, and usual care (no exercise training) in patient with coronary artery disease, on exercise capacity, vascular function, arrhythmogenic potential and cardiac autonomic function, and markers of neurohormonal activity, activated hemostasis and inflammation.

Conditions

Coronary Artery Disease

Keywords

cardiac rehabilitation; coronary artery disease

Outcome Measures

Primary Outcomes (1)

• Change of maximal oxygen consumption during cardiopulmonary bicycle exercise testing

  14 days

Secondary Outcomes (8)

• Change of flow-mediated dilation of brachial artery measured in %

  14 days

• Change of arrhythmogenic potential estimated by high resolution ECG

  14 days

• Change of the C-reactive protein serum concentration value, measured in g/l

  14 days

• Change of N terminal - proBNP serum concentration value , measured in ng/l

  14 days

• Change of the D-dimer serum concentration value, measured in microg/l

  14 days

Study Arms (3)

Water-based exercise training group

ACTIVE COMPARATOR

Intervention: Patients randomized to the "water-based exercise training group" will undergo water-based exercise training. The immersed exercise will include two session of aerobic (water-based) and calisthenic exercise per day, six days of a week, each lasting 30 minutes.

Other: water-based exercise training

Land-based exercise training group

ACTIVE COMPARATOR

Patients randomized to the "land-based exercise training group" will undergo exercise training which will include two aerobic and calisthenic exercise session per day, six days of a week, lasting 30 minutes

Other: land-based exercise training

Control group (usual care)

NO INTERVENTION

Control group: patients randomized in control group will have usual care with no exercise

Interventions

water-based exercise training OTHER

Water-based training will be performed in upright position, in waist to xyphoid process deep thermo-neutral water at temperature of 32,8 C. The immersed exercise will include two session of aerobic and calisthenic exercise per day, six days of a week, both lasting 30 minutes

Water-based exercise training group

land-based exercise training OTHER

Land-based training will include two aerobic and calisthenic exercise session per day, six days of a week, both lasting 30 minutes

Land-based exercise training group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with coronary artery disease after myocardial infarction or myocardial revascularization (percutaneous coronary procedure or surgical revascularization)

You may not qualify if:

• unstable coronary artery disease, ejection fraction of the left ventricle of 40% or less, heart valve defect that dictate specific treatment, condition after valve replacement, heart rhythm disorders, the presence of a permanent pacemaker, contraindications to exercise, inability to perform exercise testing, mental retardation, severe anemia, obstructive/restrictive lung disease severe degree, recent thrombo embolic events, age over 80 years.

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead
• KRKA: collaborator

Study Sites (2)

University medical center Ljubljana

Ljubljana, 1000, Slovenia

Location

Terme Krka

Novo Mesto, 8000, Slovenia

Location

Related Publications (12)

• Piepoli MF, Corra U, Benzer W, Bjarnason-Wehrens B, Dendale P, Gaita D, McGee H, Mendes M, Niebauer J, Zwisler AD, Schmid JP; Cardiac Rehabilitation Section of the European Association of Cardiovascular Prevention and Rehabilitation. Secondary prevention through cardiac rehabilitation: from knowledge to implementation. A position paper from the Cardiac Rehabilitation Section of the European Association of Cardiovascular Prevention and Rehabilitation. Eur J Cardiovasc Prev Rehabil. 2010 Feb;17(1):1-17. doi: 10.1097/HJR.0b013e3283313592.

  PMID: 19952757 BACKGROUND

• Aspry K, Wu WC, Salmoirago-Blotcher E. Cardiac Rehabilitation in Patients with Established Atherosclerotic Vascular Disease: New Directions in the Era of Value-Based Healthcare. Curr Atheroscler Rep. 2016 Feb;18(2):10. doi: 10.1007/s11883-016-0561-x.

  PMID: 26803511 BACKGROUND

• St John Sutton M, Lee D, Rouleau JL, Goldman S, Plappert T, Braunwald E, Pfeffer MA. Left ventricular remodeling and ventricular arrhythmias after myocardial infarction. Circulation. 2003 May 27;107(20):2577-82. doi: 10.1161/01.CIR.0000070420.51787.A8. Epub 2003 May 5.

  PMID: 12732606 BACKGROUND

• McDermott MM, Greenland P, Guralnik JM, Ferrucci L, Green D, Liu K, Criqui MH, Schneider JR, Chan C, Ridker P, Pearce WH, Martin G, Clark E, Taylor L. Inflammatory markers, D-dimer, pro-thrombotic factors, and physical activity levels in patients with peripheral arterial disease. Vasc Med. 2004 May;9(2):107-15. doi: 10.1191/1358863x04vm525oa.

  PMID: 15521700 BACKGROUND

• Passino C, Severino S, Poletti R, Piepoli MF, Mammini C, Clerico A, Gabutti A, Nassi G, Emdin M. Aerobic training decreases B-type natriuretic peptide expression and adrenergic activation in patients with heart failure. J Am Coll Cardiol. 2006 May 2;47(9):1835-9. doi: 10.1016/j.jacc.2005.12.050. Epub 2006 Apr 19.

  PMID: 16682309 BACKGROUND

• Swardfager W, Herrmann N, Cornish S, Mazereeuw G, Marzolini S, Sham L, Lanctot KL. Exercise intervention and inflammatory markers in coronary artery disease: a meta-analysis. Am Heart J. 2012 Apr;163(4):666-76.e1-3. doi: 10.1016/j.ahj.2011.12.017.

  PMID: 22520533 BACKGROUND

• Autenrieth C, Schneider A, Doring A, Meisinger C, Herder C, Koenig W, Huber G, Thorand B. Association between different domains of physical activity and markers of inflammation. Med Sci Sports Exerc. 2009 Sep;41(9):1706-13. doi: 10.1249/MSS.0b013e3181a15512.

  PMID: 19657301 BACKGROUND

• Hammett CJ, Prapavessis H, Baldi JC, Varo N, Schoenbeck U, Ameratunga R, French JK, White HD, Stewart RA. Effects of exercise training on 5 inflammatory markers associated with cardiovascular risk. Am Heart J. 2006 Feb;151(2):367.e7-367.e16. doi: 10.1016/j.ahj.2005.08.009.

  PMID: 16442901 BACKGROUND

• Teffaha D, Mourot L, Vernochet P, Ounissi F, Regnard J, Monpere C, Dugue B. Relevance of water gymnastics in rehabilitation programs in patients with chronic heart failure or coronary artery disease with normal left ventricular function. J Card Fail. 2011 Aug;17(8):676-83. doi: 10.1016/j.cardfail.2011.04.008. Epub 2011 May 31.

  PMID: 21807330 BACKGROUND

• Vona M, Codeluppi GM, Iannino T, Ferrari E, Bogousslavsky J, von Segesser LK. Effects of different types of exercise training followed by detraining on endothelium-dependent dilation in patients with recent myocardial infarction. Circulation. 2009 Mar 31;119(12):1601-8. doi: 10.1161/CIRCULATIONAHA.108.821736. Epub 2009 Mar 16.

  PMID: 19289636 BACKGROUND

• Tokmakidis SP, Spassis AT, Volaklis KA. Training, detraining and retraining effects after a water-based exercise program in patients with coronary artery disease. Cardiology. 2008;111(4):257-64. doi: 10.1159/000127737. Epub 2008 Apr 23.

  PMID: 18434735 BACKGROUND

• Vasic D, Novakovic M, Bozic Mijovski M, Barbic Zagar B, Jug B. Short-Term Water- and Land-Based Exercise Training Comparably Improve Exercise Capacity and Vascular Function in Patients After a Recent Coronary Event: A Pilot Randomized Controlled Trial. Front Physiol. 2019 Jul 16;10:903. doi: 10.3389/fphys.2019.00903. eCollection 2019.

  PMID: 31379605 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Borut Jug, MD, PhD

  University Medical Centre Ljubljana

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: July 13, 2016
• Study Start: May 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: May 1, 2017
• Last Updated: November 14, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share

Locations

SL (2)