Coronary Artery DiseaseNCT02831829
Influence of Different Forms of Exercise Training in Patients With Coronary Artery Disease
A study testing water-based exercise training and land-based exercise training in people with Coronary Artery Disease, run by University Medical Centre Ljubljana at 2 sites in Slovenia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- water-based exercise training and land-based exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesSlovenia
- Study dates
- May 2016to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with coronary artery disease after myocardial infarction or myocardial revascularization (percutaneous coronary procedure or surgical revascularization)
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Slovenia2 sites
University medical center Ljubljana
Ljubljana, 1000
Terme Krka
Novo Mesto, 8000
About this study
Official title: Comparative Effect of Water-based and Land-based Exercise Training on Exercise Capacity and Other Selected Cardiovascular Parameters in Patients With Coronary Artery Disease
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.
Read the detailed description
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.
- Conditions
- Coronary Artery Disease
- Being tested
- water-based exercise training, land-based exercise training
- Keywords
- cardiac rehabilitation, coronary artery disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
water-based exercise trainingOther
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 trainingOther
Land-based training will include two aerobic and calisthenic exercise session per day, six days of a week, both lasting 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of maximal oxygen consumption during cardiopulmonary bicycle exercise testing
Measured: 14 days
Secondary outcomes (8)
Change of flow-mediated dilation of brachial artery measured in %
Measured: 14 days
Change of arrhythmogenic potential estimated by high resolution ECG
Measured: 14 days
Change of the C-reactive protein serum concentration value, measured in g/l
Measured: 14 days
Change of N terminal - proBNP serum concentration value , measured in ng/l
Measured: 14 days
Change of the D-dimer serum concentration value, measured in microg/l
Measured: 14 days
Change in fibrinogen serum concentration value, measured in g/l
Measured: 14 days
Change of from-the-questionnaire-obtained quality of life, measured in points
Measured: 14 days
Change in heart rate variability, estimated by high resolution ECG
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study startMay 2016
- Primary completionOct 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- KRKA
- Responsible party
- Principal investigator, Borut Jug, University Medical Centre Ljubljana
- Investigators
- Borut Jug, MD, PhD, Study chair, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02831829
- Sponsor's protocol ID
- UKCLRehab0012016
- Status last verified
- Nov 2017
- First submitted
- 11 Jul 2016
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 19952757Aspry 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.
PubMed 26803511St 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.
PubMed 12732606McDermott 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.
PubMed 15521700Passino 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.
PubMed 16682309Swardfager 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.
PubMed 22520533Autenrieth 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.
PubMed 19657301Hammett 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.
PubMed 16442901Teffaha 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.
PubMed 21807330Vona 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.
PubMed 19289636Tokmakidis 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.
PubMed 18434735Vasic 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.
PubMed 31379605
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effect of Water-based and Land-based Exercise Training on Exercise Capacity and Other Selected Cardiovascular Parameters in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT02831829
- Acronym / sponsor ID
- UKCLRehab0012016
- Conditions
- Coronary Artery Disease
- Keywords
- cardiac rehabilitation, coronary artery disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- KRKA
- Study start
- May 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 13 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Water-based exercise training group | Active comparator | Other: water-based exercise trainingIntervention: 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 | Other: land-based exercise trainingPatients 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with coronary artery disease after myocardial infarction or myocardial revascularization (percutaneous coronary procedure or surgical revascularization)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| water-based exercise trainingWater-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 | Other | Water-based exercise training group |
| land-based exercise trainingLand-based training will include two aerobic and calisthenic exercise session per day, six days of a week, both lasting 30 minutes | Other | Land-based exercise training group |
Primary outcome
Change of maximal oxygen consumption during cardiopulmonary bicycle exercise testing
Time frame: 14 days
8 secondary outcomes
Change of flow-mediated dilation of brachial artery measured in %
Time frame: 14 days
Change of arrhythmogenic potential estimated by high resolution ECG
Time frame: 14 days
Change of the C-reactive protein serum concentration value, measured in g/l
Time frame: 14 days
Change of N terminal - proBNP serum concentration value , measured in ng/l
Time frame: 14 days
Change of the D-dimer serum concentration value, measured in microg/l
Time frame: 14 days
Change in fibrinogen serum concentration value, measured in g/l
Time frame: 14 days
Change of from-the-questionnaire-obtained quality of life, measured in points
Time frame: 14 days
Change in heart rate variability, estimated by high resolution ECG
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
- Background: PubMed 19952757Piepoli 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.
- Background: PubMed 26803511Aspry 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.
- Background: PubMed 12732606St 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.
- Background: PubMed 15521700McDermott 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.
- Background: PubMed 16682309Passino 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.
- Background: PubMed 22520533Swardfager 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.
- Background: PubMed 19657301Autenrieth 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.
- Background: PubMed 16442901Hammett 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.
- Background: PubMed 21807330Teffaha 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.
- Background: PubMed 19289636Vona 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.
- Background: PubMed 18434735Tokmakidis 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.
- Derived from this study: PubMed 31379605Vasic 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Borut Jug, MD, PhD study chair
University Medical Centre Ljubljana
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing water-based exercise training and land-based exercise training in people with Coronary Artery Disease, run by University Medical Centre Ljubljana at 2 sites in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of maximal oxygen consumption during cardiopulmonary bicycle exercise testing (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02831829, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2017.