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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

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.

Condition or disease Intervention/treatment Phase
Atherosclerosis Coronary Artery Disease Behavioral: INT Behavioral: CONT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interval Training in Cardiac Rehabilitation: Effects on Cardiorespiratory Fitness and Platelet Function - A Randomized Controlled Trial
Study Start Date : October 2015
Actual Primary Completion Date : June 14, 2017
Actual Study Completion Date : June 14, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Interval

2x / week INT

2x / week CONT

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

Active Comparator: Continuous
4x / week CONT
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




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.


  2. Cardiorespiratory fitness: Maximal power output [ Time Frame: 6 weeks ]
    Maximal power output (Watt / kg bodyweight) at the end of an incremental exercise test

  3. Cardiorespiratory fitness: Maximal power output [ Time Frame: 12 weeks ]
    Maximal power output (Watt / kg bodyweight) at the end of an incremental exercise test

  4. Cardiorespiratory fitness: Maximal oxygen consumption [ Time Frame: 6 weeks ]
    Maximal oxygen consumption (ml/min/kg bodyweight) at the end of an incremental exercise test

  5. Cardiorespiratory fitness: Maximal oxygen consumption [ Time Frame: 12 weeks ]
    Maximal oxygen consumption (ml/min/kg bodyweight) at the end of an incremental exercise test



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02930330


Locations
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Austria
MUVienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Medical Scientific Fund of the Mayor of Vienna
Austrian Heart Funds
Investigators
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Principal Investigator: Stefan Heber, MD Medical University of Vienna
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Stefan Heber, Dr. Med. Univ., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02930330    
Other Study ID Numbers: Heber 15136
First Posted: October 12, 2016    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Stefan Heber, Medical University of Vienna:
Exercise
Interval training
Blood platelets
Platelet function tests
Physical fitness
Rehabilitation
Additional relevant MeSH terms:
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Coronary Artery Disease
Atherosclerosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases