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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparative Effect of Water-based and Land-based Exercise Training on Exercise Capacity and Other Selected Cardiovascular Parameters in Patients With Coronary Artery Disease

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Other: water-based exercise training
* Other: land-based exercise training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with coronary artery disease after myocardial infarction or myocardial revascularization (percutaneous coronary procedure or surgical revascularization) Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Water-based exercise training group<br>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<br>* 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<br>|
| Active Comparator: Land-based exercise training group<br>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<br>* Land-based training will include two aerobic and calisthenic exercise session per day, six days of a week, both lasting 30 minutes<br>|
| No Intervention: Control group (usual care)<br>Control group: patients randomized in control group will have usual care with no exercise | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of maximal oxygen consumption during cardiopulmonary bicycle exercise testing |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac rehabilitation, coronary artery disease