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| Name | Class |
|---|---|
| KRKA | INDUSTRY |
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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.
Swimming and other water-based physical activities represent an effective form of aerobic-dynamic exercise. However, existing guidelines mainly advise caution when recommending water-based activities to patients with coronary artery disease. To date, safety and efficacy of short-term water-based exercise in patients with coronary artery diseases have only scarcely been addressed.
Cardiovascular rehabilitation is an integral part of management after a myocardial infarction or coronary procedure. Most rehabilitation programs are exercise-based, since the beneficial effects of physical activity undisputed, and corroborated by a large body of evidence.
Most rehabilitation programs are exercise-based, since the beneficial effects of physical activity undisputed, and corroborated by a large body of evidence.
Research has mainly been focused on the impact assessment of the standard forms of physical training, they studied various forms of physical exercise, mainly land-based. No previous study has reported on the effect of exercise in water as an integral element of standard cardiac rehabilitation in coronary patients on exercise capacity, vascular function, arrhythmogenic potential and cardiac autonomic function, and markers of neurohormonal activity, activated hemostasis and inflammation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Control group (usual care) | No Intervention | Control group: patients randomized in control group will have usual care with no exercise |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of maximal oxygen consumption during cardiopulmonary bicycle exercise testing | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Borut Jug, MD, PhD | University Medical Centre Ljubljana | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University medical center Ljubljana | Ljubljana | 1000 | Slovenia | |||
| Terme Krka |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19952757 | Background | 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. | |
| 26803511 |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| 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 |
|
| 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 |
| Change in fibrinogen serum concentration value, measured in g/l | 14 days |
| Change of from-the-questionnaire-obtained quality of life, measured in points | 14 days |
| Change in heart rate variability, estimated by high resolution ECG | 14 days |
| Novo Mesto |
| 8000 |
| Slovenia |
| 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. |
| 12732606 | 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. |
| 15521700 | 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. |
| 16682309 | 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. |
| 22520533 | 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. |
| 19657301 | 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. |
| 16442901 | 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. |
| 21807330 | 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. |
| 19289636 | 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. |
| 18434735 | 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. |
| 31379605 | Derived | 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. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |