Clinical trial NCT02930330: Interval Training in Cardiac Rehabilitation
Official title: Interval Training in Cardiac Rehabilitation: Effects on Cardiorespiratory Fitness and Platelet Function - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atherosclerosis
Coronary Artery Disease
Keywords: Exercise
Interval training
Blood platelets
Platelet function tests
Physical fitness
Rehabilitation
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Medical Scientific Fund of the Mayor of Vienna
name: Austrian Heart Funds
First posted: 2016-10-12
Enrollment: 82
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Platelet reactivity at physical rest: EC50 of TRAP-6 in terms of platelet CD62P expression. Unit of Measure: µM (Micromolar)
timeFrame: 6 weeks
Secondary outcomes:
measure: Platelet reactivity at physical rest: EC50 of TRAP-6 in terms of platelet CD62P expression. Unit of Measure: µM
timeFrame: 12 weeks
measure: Cardiorespiratory fitness: Maximal power output
timeFrame: 6 weeks
measure: Cardiorespiratory fitness: Maximal power output
timeFrame: 12 weeks
measure: Cardiorespiratory fitness: Maximal oxygen consumption
timeFrame: 6 weeks
measure: Cardiorespiratory fitness: Maximal oxygen consumption
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: MUVienna
Study officials:
affiliation: Medical University of Vienna
name: Stefan Heber, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.