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Exercise Training in Individuals With Coronary Artery Disease (ReKoBo)

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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

Tracking Information
First Submitted Date  ICMJE January 6, 2019
First Posted Date  ICMJE January 30, 2019
Last Update Posted Date May 19, 2020
Actual Study Start Date  ICMJE March 1, 2019
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2019)
Change of flow-mediated dilatation of the brachial artery, measured in % [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2020)
  • Change of the arterial stiffness coefficient [ Time Frame: 3 months ]
  • Change of maximal oxygen uptake during exercise, measured in ml/kg/min [ Time Frame: 3 months ]
  • Change of the heart rate variability [ Time Frame: 3 months ]
  • Change of the heart rate recovery [ Time Frame: 3 months ]
  • 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)
  • Change in IL-6, IL-8, IL-10, TNF-alpha and NT-proBNP levels, measured in ng/l [ Time Frame: 3 months ]
  • Change in osteopontin and D-dimer levels, measured in microg/l [ Time Frame: 3 months ]
  • Change in selectin and hsCRP, measured in mg/l [ Time Frame: 3 months ]
  • Change in hsTnI, CK MB, endocan, sST2, galectin-3, NGAL, CD40 ligand and BDNF, measured in ng/l [ Time Frame: 3 months ]
  • Change in copeptin levels, measured in pmol/l [ Time Frame: 3 months ]
  • Change in MR-proADM and MR-proANP, measured in nmol/l [ Time Frame: 3 months ]
  • Change in homoarginine, ADMA and SDMA levels, measured in micromol/l [ Time Frame: 3 months ]
  • Change in fibrinogen and Lp(a) levels, measured in mg/dl [ Time Frame: 3 months ]
  • Change in insuline level, measure in microIU/ml [ Time Frame: 3 months ]
  • Change in total cholesterol, LDL, HDL, triglycerides and glucose levels, measured in mmol/l [ Time Frame: 3 months ]
  • Change in overall haemostatic potential [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2019)
  • Change of the arterial stiffness coefficient [ Time Frame: 3 months ]
  • Change of maximal oxygen uptake during exercise, measured in ml/kg/min [ Time Frame: 3 months ]
  • Change of the heart rate variability [ Time Frame: 3 months ]
  • Change of the heart rate recovery [ Time Frame: 3 months ]
  • Change in health-related quality of life, measured in points [ Time Frame: 3 months ]
    Physical and mental subscales of the SF-36 questionnaire
  • Change in IL-6, IL-8, IL-10, TNF-alpha, NT-proBNP, norepinephrine and epinephrine levels, measured in ng/l [ Time Frame: 3 months ]
  • Change in ICAM and D-dimer levels, measured in microg/l [ Time Frame: 3 months ]
  • Change in selectin and hsCRP, measured in mg/l [ Time Frame: 3 months ]
  • Change in hsTnI, CK MB, endocan, sST2, galectin-3, NGAL and cortisol, measured in ng/l [ Time Frame: 3 months ]
  • Change in copeptin levels, measured in pmol/l [ Time Frame: 3 months ]
  • Change in MR-proADM and MR-proANP, measured in nmol/l [ Time Frame: 3 months ]
  • Change in homoarginine, ADMA and SDMA levels, measured in micromol/l [ Time Frame: 3 months ]
  • Change in fibrinogen and Lp(a) levels, measured in mg/dl [ Time Frame: 3 months ]
  • Change in insuline level, measure in microIU/ml [ Time Frame: 3 months ]
  • Change in total cholesterol, LDL, HDL, triglycerides and glucose levels, measured in mmol/l [ Time Frame: 3 months ]
  • Change in overall haemostatic potential [ Time Frame: 3 months ]
Current Other Pre-specified Outcome Measures
 (submitted: May 17, 2020)
  • Change in the flow-mediated dilation during single exercise training session, measured in % [ Time Frame: 3 months ]
  • 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 ]
  • Change in selectin and hsCRP during single exercise training session, measured in mg/l [ Time Frame: 3 months ]
  • 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 ]
  • Change in copeptin levels during single exercise training session, measured in pmol/l [ Time Frame: 3 months ]
  • Change in homoarginine, ADMA and SDMA levels during single exercise training session, measured in micromol/l [ Time Frame: 3 months ]
  • Change in fibrinogen level during single exercise training session, measured in mg/dl [ Time Frame: 3 months ]
  • Change in insuline levels during single exercise training session, measure in microIU/ml [ Time Frame: 3 months ]
  • Change in osteopontin and D-dimer levels during single exercise training session, measured in microg/l [ Time Frame: 3 months ]
  • Change in overall haemostatic potential during single exercise training session [ Time Frame: 3 months ]
Original Other Pre-specified Outcome Measures
 (submitted: January 27, 2019)
  • Change in the flow-mediated dilation during single exercise training session, measured in % [ Time Frame: 3 months ]
  • Change in IL-6, IL-8, IL-10, TNF-alpha, NT-proBNP, norepinephrine and epinephrine levels during single exercise training session, measured in ng/l [ Time Frame: 3 months ]
  • Change in selectin and hsCRP during single exercise training session, measured in mg/l [ Time Frame: 3 months ]
  • Change in hsTnI, CK MB, endocan, sST2, galectin-3, NGAL and cortisol levels during single exercise training session, measured in ng/l [ Time Frame: 3 months ]
  • Change in copeptin levels during single exercise training session, measured in pmol/l [ Time Frame: 3 months ]
  • Change in homoarginine, ADMA and SDMA levels during single exercise training session, measured in micromol/l [ Time Frame: 3 months ]
  • Change in fibrinogen level during single exercise training session, measured in mg/dl [ Time Frame: 3 months ]
  • Change in insuline levels during single exercise training session, measure in microIU/ml [ Time Frame: 3 months ]
  • Change in overall haemostatic potential during single exercise training session [ Time Frame: 3 months ]
 
Descriptive Information
Brief Title  ICMJE Exercise Training in Individuals With Coronary Artery Disease
Official Title  ICMJE Cardiovascular Rehabilitation in Coronary Artery Disease Patients: Influence of Different Types of Exercise Training on Selected Cardiovascular Parameters
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Coronary Artery Disease
  • Myocardial Infarction
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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).
    Intervention: Other: Exercise training
  • 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.
    Intervention: Other: Exercise training
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 27, 2019)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2021
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marko Novaković, MD, PhD +386 (0)1 522 7212 markonovakovic@rocketmail.com
Listed Location Countries  ICMJE Slovenia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03821558
Other Study ID Numbers  ICMJE UKCLRehab0012019
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Borut Jug, University Medical Centre Ljubljana
Study Sponsor  ICMJE University Medical Centre Ljubljana
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Borut Jug, MD, PhD University Medical Centre Ljubljana
PRS Account University Medical Centre Ljubljana
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP