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Clinical Trials/NCT03821558
NCT03821558
Completed
N/A

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

University Medical Centre Ljubljana1 site in 1 country115 target enrollmentMarch 1, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
University Medical Centre Ljubljana
Enrollment
115
Locations
1
Primary Endpoint
Change of flow-mediated dilatation of the brachial artery, measured in %
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2019
End Date
August 1, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Borut Jug

Associate Professor

University Medical Centre Ljubljana

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Change of flow-mediated dilatation of the brachial artery, measured in %

Time Frame: 3 months

Secondary Outcomes

  • Change of the arterial stiffness coefficient(3 months)
  • Change of maximal oxygen uptake during exercise, measured in ml/kg/min(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 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)
  • 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)

Study Sites (1)

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