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Interval Training in Cardiac Rehabilitation

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ClinicalTrials.gov Identifier: NCT02930330
Recruitment Status : Completed
First Posted : October 12, 2016
Last Update Posted : August 31, 2017
Sponsor:
Collaborators:
Medical Scientific Fund of the Mayor of Vienna
Austrian Heart Funds
Information provided by (Responsible Party):
Stefan Heber, Medical University of Vienna

Tracking Information
First Submitted Date  ICMJE October 7, 2016
First Posted Date  ICMJE October 12, 2016
Last Update Posted Date August 31, 2017
Study Start Date  ICMJE October 2015
Actual Primary Completion Date June 14, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2016)
Platelet reactivity at physical rest: EC50 of TRAP-6 in terms of platelet CD62P expression. Unit of Measure: µM (Micromolar) [ Time Frame: 6 weeks ]
Platelet reactivity as measured by half maximal effective concentration (EC50) of the platelet agonist TRAP-6 (Thrombin receptor activating peptide-6; SFLLRN) in terms of platelet CD62P (P-selectin) expression, as described in Heber et al. 2016 (PMID: 26909532). The percentage of CD62P expressing platelets is quantified by flow cytometry without and with increasing concentrations of the platelet agonist TRAP-6. EC50 of TRAP-6 is estimated by fitting a four parameter logistic dose-response curve to flow cytometry data as a function of agonist concentration, aggregating multiple measurements to one reported value (EC50) with the unit µM. Treatment effects on platelet reactivity at physical rest after 6 weeks (INT vs. CONT) are estimated by ANCOVA, with baseline values as covariate.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2016)
  • Platelet reactivity at physical rest: EC50 of TRAP-6 in terms of platelet CD62P expression. Unit of Measure: µM [ Time Frame: 12 weeks ]
    Platelet reactivity as measured by half maximal effective concentration (EC50) of the platelet agonist TRAP-6 (Thrombin receptor activating peptide-6; SFLLRN) in terms of platelet CD62P (P-selectin) expression. The percentage of CD62P expressing platelets is quantified by flow cytometry without and with increasing concentrations of the platelet agonist TRAP-6. EC50 of TRAP-6 is estimated by fitting a four parameter logistic dose-response curve to flow cytometry data as a function of agonist concentration, aggregating multiple measurements to one reported value (EC50) with the unit µM. Treatment effects on platelet reactivity at physical rest after 12 weeks (INT vs. CONT) are estimated by ANCOVA, with baseline values as covariate.
  • Cardiorespiratory fitness: Maximal power output [ Time Frame: 6 weeks ]
    Maximal power output (Watt / kg bodyweight) at the end of an incremental exercise test
  • Cardiorespiratory fitness: Maximal power output [ Time Frame: 12 weeks ]
    Maximal power output (Watt / kg bodyweight) at the end of an incremental exercise test
  • Cardiorespiratory fitness: Maximal oxygen consumption [ Time Frame: 6 weeks ]
    Maximal oxygen consumption (ml/min/kg bodyweight) at the end of an incremental exercise test
  • Cardiorespiratory fitness: Maximal oxygen consumption [ Time Frame: 12 weeks ]
    Maximal oxygen consumption (ml/min/kg bodyweight) at the end of an incremental exercise test
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Interval Training in Cardiac Rehabilitation
Official Title  ICMJE Interval Training in Cardiac Rehabilitation: Effects on Cardiorespiratory Fitness and Platelet Function - A Randomized Controlled Trial
Brief Summary The purpose of this study is to determine whether high intensity interval training (INT) is more effective in suppressing platelet reactivity than continuous, moderate intensity training (CONT) in patients undergoing cardiac rehabilitation after percutaneous coronary intervention.
Detailed Description

Background: Platelets play an important role in cardiovascular disease: First, they promote the development of atherosclerotic lesions, and second, platelets form vessel occluding thrombi on top of (ruptured) lesions, ultimately leading to thrombotic events like myocardial infarctions (MCI). Whereas acute, strenuous exercise causes platelet activation and transiently increases the risk for MCIs, long-term chronic exercise training results in a clear reduction of both platelet activation and MCI incidence.

Exercise training plays a key role in cardiac rehabilitation, since improvements in cardiorespiratory fitness (CRF) are associated with decreased mortality in these patients. With respect to CRF improvements, high-intensity interval training has been demonstrated to be more effective than moderate-intensity continuous exercise. However, the beneficial effect of high-intensity interval training on platelet function in patients with cardiovascular disease has never been investigated.

Scientific question: The aim of this study is to determine the effect of interval training in cardiac rehabilitation on platelet function.

Hypotheses: Cardiac rehabilitation with interval training components (INT) reduces

  1. platelet activation and platelet reactivity at physical rest
  2. changes of platelet activation and -reactivity induced by acute, strenuous exercise to a greater extent than cardiac rehabilitation consisting exclusively of moderate-intensity continuous exercise training (CONT).

Work program: 80 patients at the beginning of phase II cardiac rehabilitation will be randomly assigned to an interval group or to a control group. In both groups, patients will exercise 4x / week for 12 weeks. At the beginning, after 6 weeks and at the end an exercise test will be carried out. Blood will be taken before (platelet function at rest) and immediately after each exercise test (platelet function after acute, strenuous exercise). Basal platelet activation as well as platelet responsiveness towards a platelet agonist (platelet reactivity) will be analyzed.

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
  • Atherosclerosis
  • Coronary Artery Disease
Intervention  ICMJE
  • Behavioral: INT
    • 5 min warm-up (40% Pmax*)
    • 30 min high intensity interval training (1 min 100% Pmax, 1 min 20% Pmax, in alternating sequence)
    • 10 min cool-down (30% Pmax)

    Pmax*: Maximal power output (Watt) achieved at the end of an incremental exercise test.

    Other Name: High intensity interval training
  • Behavioral: CONT
    • 5 min warm-up (40% Pmax*)
    • 30 min moderate intensity continuous training (60% Pmax)
    • 10 min cool-down (30% Pmax)

    Pmax*: Maximal power output (Watt) achieved at the end of an incremental exercise test.

    Other Name: Moderate intensity continuous training
Study Arms  ICMJE
  • Experimental: Interval

    2x / week INT

    2x / week CONT

    Interventions:
    • Behavioral: INT
    • Behavioral: CONT
  • Active Comparator: Continuous
    4x / week CONT
    Intervention: Behavioral: CONT
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 Completed
Actual Enrollment  ICMJE
 (submitted: August 30, 2017)
82
Original Estimated Enrollment  ICMJE
 (submitted: October 8, 2016)
80
Actual Study Completion Date  ICMJE June 14, 2017
Actual Primary Completion Date June 14, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • No regular exercise training within the last 6 months
  • Dual anti-platelet therapy (low-dose aspirin plus ADP(adenosine diphosphate)-receptor antagonist)
  • Status post percutaneous coronary intervention after recent acute coronary syndrome as underlying reason for current rehabilitation
  • Eligibility for outpatient cardiac rehabilitation according to Table I in Niebauer et al. 2013 (PMID: 22508693)

Exclusion Criteria:

  • Type II diabetes mellitus
  • Aortic aneurysm / dissection
  • Uncontrolled hypertension (>180/110 mmHg)
  • Pulmonary hypertension (>55 mmHg)
  • Previously known hereditary platelet disorders
  • Disorders of plasmatic coagulation
  • Anemia (Hb < 13g/dl)
  • History of end-stage liver or kidney disease
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02930330
Other Study ID Numbers  ICMJE Heber 15136
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Stefan Heber, Medical University of Vienna
Study Sponsor  ICMJE Medical University of Vienna
Collaborators  ICMJE
  • Medical Scientific Fund of the Mayor of Vienna
  • Austrian Heart Funds
Investigators  ICMJE
Principal Investigator: Stefan Heber, MD Medical University of Vienna
PRS Account Medical University of Vienna
Verification Date August 2017

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