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Completed

NCT Number: NCT03821558

Exercise Training in Individuals With Coronary Artery Disease

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Behavior Cardiovascular Diseases Coronary Disease Heart Diseases Infarction Ischemia Motor Activity Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Centre Ljubljana

Ljubljana, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise training

Other

Patients to be randomized to the 'interval training group' or 'continuous training group' will undergo exercise training sessions with different intensity levels.

Primary outcomes

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

    Time frame: 3 months

Secondary outcomes

  1. Change of the arterial stiffness coefficient

    Time frame: 3 months

  2. Change of maximal oxygen uptake during exercise, measured in ml/kg/min

    Time frame: 3 months

  3. Change of the heart rate variability

    Time frame: 3 months

  4. Change of the heart rate recovery

    Time frame: 3 months

  5. Change in health-related quality of life using SF-36 questionnaire, measured in points

    Time frame: 3 months

    It is a self-administered questionnaire comprising 36 items measuring eight dimensions and two subscales (physical and mental)

  6. Change in IL-6, IL-8, IL-10, TNF-alpha and NT-proBNP levels, measured in ng/l

    Time frame: 3 months

  7. Change in osteopontin and D-dimer levels, measured in microg/l

    Time frame: 3 months

  8. Change in selectin and hsCRP, measured in mg/l

    Time frame: 3 months

  9. Change in hsTnI, CK MB, endocan, sST2, galectin-3, NGAL, CD40 ligand and BDNF, measured in ng/l

    Time frame: 3 months

  10. Change in copeptin levels, measured in pmol/l

    Time frame: 3 months

  11. Change in MR-proADM and MR-proANP, measured in nmol/l

    Time frame: 3 months

  12. Change in homoarginine, ADMA and SDMA levels, measured in micromol/l

    Time frame: 3 months

  13. Change in fibrinogen and Lp(a) levels, measured in mg/dl

    Time frame: 3 months

  14. Change in insuline level, measure in microIU/ml

    Time frame: 3 months

  15. Change in total cholesterol, LDL, HDL, triglycerides and glucose levels, measured in mmol/l

    Time frame: 3 months

  16. Change in overall haemostatic potential

    Time frame: 3 months

Other outcomes

  1. Change in the flow-mediated dilation during single exercise training session, measured in %

    Time frame: 3 months

  2. Change in IL-6, IL-8, IL-10, TNF-alpha and NT-proBNP levels during single exercise training session, measured in ng/l

    Time frame: 3 months

  3. Change in selectin and hsCRP during single exercise training session, measured in mg/l

    Time frame: 3 months

  4. Change in hsTnI, CK MB, endocan, sST2, galectin-3, NGAL, CD40 ligand and BDNF levels during single exercise training session, measured in ng/l

    Time frame: 3 months

  5. Change in copeptin levels during single exercise training session, measured in pmol/l

    Time frame: 3 months

  6. Change in homoarginine, ADMA and SDMA levels during single exercise training session, measured in micromol/l

    Time frame: 3 months

  7. Change in fibrinogen level during single exercise training session, measured in mg/dl

    Time frame: 3 months

  8. Change in insuline levels during single exercise training session, measure in microIU/ml

    Time frame: 3 months

  9. Change in osteopontin and D-dimer levels during single exercise training session, measured in microg/l

    Time frame: 3 months

  10. Change in overall haemostatic potential during single exercise training session

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

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

Acronym: ReKoBo

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jan 30, 2019
Registry last updated
Dec 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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