Influence of Different Forms of Exercise Training in Patients With Coronary Artery Disease
NCT ID: NCT02831829
Last Updated: 2017-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
90 participants
INTERVENTIONAL
2016-05-31
2017-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Water-based exercise training group
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.
water-based exercise training
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
Land-based exercise training group
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
land-based exercise training
Land-based training will include two aerobic and calisthenic exercise session per day, six days of a week, both lasting 30 minutes
Control group (usual care)
Control group: patients randomized in control group will have usual care with no exercise
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
water-based exercise training
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
land-based exercise training
Land-based training will include two aerobic and calisthenic exercise session per day, six days of a week, both lasting 30 minutes
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
KRKA
INDUSTRY
University Medical Centre Ljubljana
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Borut Jug
Assistant professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Borut Jug, MD, PhD
Role: STUDY_CHAIR
University Medical Centre Ljubljana
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University medical center Ljubljana
Ljubljana, , Slovenia
Terme Krka
Novo Mesto, , Slovenia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UKCLRehab0012016
Identifier Type: -
Identifier Source: org_study_id