Exercise Training in Individuals With Coronary Artery Disease

Study Overview
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Brief Summary
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In this controlled trial, patients referred to post-myocardial infarction cardiac rehabilitation will be randomized to either interval or continuous training.

Detailed Description
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The trial would i) compare the acute effects of each exercise type on selected cardiovascular indicators; ii) compare the chronic effects of each exercise type on selected cardiovascular indicators; iii) provide information on the association between acute and chronic effects of each exercise type; iv) provide insight into possible mechanisms of effectiveness of each exercise type; v) identify the most safe and effective exercise type for patients with coronary artery disease.

Official Title
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Cardiovascular Rehabilitation in Coronary Artery Disease Patients: Influence of Different Types of Exercise Training on Selected Cardiovascular Parameters

Conditions
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Coronary Artery Disease, Myocardial Infarction

Intervention / Treatment
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* Other: Exercise training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: myocardium infarction 120 days prior to cardiac rehabilitation Exclusion Criteria: contraindications for exercise training, uncontrolled dysrhythmias, uncontrolled heart failure (New York Heart Association (NYHA) stage IV), intellectual development disorder, pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Interval training group<br>Patients to be randomized to the 'interval training group' will have exercise training sessions 3 times per week for a period of 12 weeks. During training, they will undergo interval exercise series composed of high-intensity intervals (80-90% of peak exercise performance) and low-intensity intervals (60-70% of peak exercise performance). | Other: Exercise training<br>* Patients to be randomized to the 'interval training group' or 'continuous training group' will undergo exercise training sessions with different intensity levels.<br>|
| Active Comparator: Continuous training group<br>Patients to be randomized to the 'continuous training group' will have exercise training sessions 3 times per week for a period of 12 weeks. During training, they will undergo moderate continuous exercise training at 75% of peak exercise performance. | Other: Exercise training<br>* Patients to be randomized to the 'interval training group' or 'continuous training group' will undergo exercise training sessions with different intensity levels.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of flow-mediated dilatation of the brachial artery, measured in % |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the arterial stiffness coefficient |  | 3 months | 
| Change of maximal oxygen uptake during exercise, measured in ml/kg/min |  | 3 months | 
| Change of the heart rate variability |  | 3 months | 
| Change of the heart rate recovery |  | 3 months | 
| Change in health-related quality of life using SF-36 questionnaire, measured in points | It is a self-administered questionnaire comprising 36 items measuring eight dimensions and two subscales (physical and mental) | 3 months | 
| Change in IL-6, IL-8, IL-10, TNF-alpha and NT-proBNP levels, measured in ng/l |  | 3 months | 
| Change in osteopontin and D-dimer levels, measured in microg/l |  | 3 months | 
| Change in selectin and hsCRP, measured in mg/l |  | 3 months | 
| Change in hsTnI, CK MB, endocan, sST2, galectin-3, NGAL, CD40 ligand and BDNF, measured in ng/l |  | 3 months | 
| Change in copeptin levels, measured in pmol/l |  | 3 months | 
| Change in MR-proADM and MR-proANP, measured in nmol/l |  | 3 months | 
| Change in homoarginine, ADMA and SDMA levels, measured in micromol/l |  | 3 months | 
| Change in fibrinogen and Lp(a) levels, measured in mg/dl |  | 3 months | 
| Change in insuline level, measure in microIU/ml |  | 3 months | 
| Change in total cholesterol, LDL, HDL, triglycerides and glucose levels, measured in mmol/l |  | 3 months | 
| Change in overall haemostatic potential |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, interval training, continuous training, endothelial dysfunction