Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
82 participants
INTERVENTIONAL
2015-10-31
2017-06-14
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Interval
2x / week INT
2x / week CONT
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.
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.
Continuous
4x / week CONT
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
45 Years
MALE
No
Sponsors
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Medical Scientific Fund of the Mayor of Vienna
OTHER
Austrian Heart Funds
UNKNOWN
Medical University of Vienna
OTHER
Responsible Party
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Stefan Heber
Dr. Med. Univ.
Principal Investigators
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Stefan Heber, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Vienna
Locations
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MUVienna
Vienna, , Austria
Countries
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References
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Niebauer J, Mayr K, Tschentscher M, Pokan R, Benzer W. Outpatient cardiac rehabilitation: the Austrian model. Eur J Prev Cardiol. 2013 Jun;20(3):468-79. doi: 10.1177/2047487312446137. Epub 2012 Apr 16.
Heber S, Assinger A, Pokan R, Volf I. Correlation between Cardiorespiratory Fitness and Platelet Function in Healthy Women. Med Sci Sports Exerc. 2016 Jun;48(6):1101-10. doi: 10.1249/MSS.0000000000000882.
Heber S, Fischer B, Sallaberger-Lehner M, Hausharter M, Ocenasek H, Gleiss A, Fischer MJM, Pokan R, Assinger A, Volf I. Effects of high-intensity interval training on platelet function in cardiac rehabilitation: a randomised controlled trial. Heart. 2020 Jan;106(1):69-79. doi: 10.1136/heartjnl-2019-315130. Epub 2019 Jul 17.
Other Identifiers
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Heber 15136
Identifier Type: -
Identifier Source: org_study_id