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Exercise Training in Individuals With Coronary Artery Disease (ReKoBo)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03821558
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Borut Jug, 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Myocardial Infarction Other: Exercise training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cardiovascular Rehabilitation in Coronary Artery Disease Patients: Influence of Different Types of Exercise Training on Selected Cardiovascular Parameters
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Interval training group
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
Patients to be randomized to the 'interval training group' or 'continuous training group' will undergo exercise training sessions with different intensity levels.

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




Primary Outcome Measures :
  1. Change of flow-mediated dilatation of the brachial artery, measured in % [ Time Frame: 3 months ]

Secondary Outcome Measures :
  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 Outcome Measures:
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821558


Contacts
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Contact: Marko Novaković, MD, PhD +386 (0)1 522 7212 markonovakovic@rocketmail.com

Locations
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Slovenia
University Medical Centre Ljubljana Recruiting
Ljubljana, Slovenia
Contact: Marko Novaković, MD, PhD    +386 (0)1 522 7212    markonovakovic@rocketmail.com   
Principal Investigator: Borut Jug, MD, PhD         
Sub-Investigator: Daniel Košuta, MD         
Sub-Investigator: Barbara Krevel, MD         
Sub-Investigator: Tjaša Vižintin Cuderman, MD, PhD         
Sub-Investigator: Jerneja Tasič, MD, PhD         
Sub-Investigator: Katja Janša Trontelj, RN         
Sub-Investigator: Mojca Božič Mijovski, PhD         
Sub-Investigator: Zlatko Fras, MD, PhD         
Sub-Investigator: Jana Piculin         
Sub-Investigator: Nina Bukovec         
Sub-Investigator: Anja Zidar         
Sub-Investigator: Urška Osredkar, RN         
Sub-Investigator: Jure Tršan         
Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
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Principal Investigator: Borut Jug, MD, PhD University Medical Centre Ljubljana
Publications:

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Responsible Party: Borut Jug, Associate Professor, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT03821558    
Other Study ID Numbers: UKCLRehab0012019
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Borut Jug, University Medical Centre Ljubljana:
exercise
interval training
continuous training
endothelial dysfunction
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases