Exercise Training in Individuals With Coronary Artery Disease

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Myocardial Infarction

• Registration Number: NCT03821558
• Lead Sponsor: University Medical Centre Ljubljana

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-01-06
• Study First Submitted QC: 2019-01-27
• Study First Posted: 2019-01-30
• Study Start: 2019-03-01
• Primary Completion: 2020-06-01
• Study Completion: 2021-08-01
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-08
• Last Update Posted: 2021-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change of flow-mediated dilatation of the brachial artery, measured in %	3 months

Secondary Outcome Measures

Name	Time	Method
Change in IL-6, IL-8, IL-10, TNF-alpha and NT-proBNP levels, measured in ng/l	3 months
Change of the arterial stiffness coefficient	3 months
Change of maximal oxygen uptake during exercise, measured in ml/kg/min	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 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	3 months	It is a self-administered questionnaire comprising 36 items measuring eight dimensions and two subscales (physical and mental)
Change in total cholesterol, LDL, HDL, triglycerides and glucose levels, measured in mmol/l	3 months
Change in overall haemostatic potential	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

Trial Locations

Locations (1)

University Medical Centre Ljubljana; 🇸🇮 Ljubljana, Slovenia