- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02930330
Interval Training in Cardiac Rehabilitation
Interval Training in Cardiac Rehabilitation: Effects on Cardiorespiratory Fitness and Platelet Function - A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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
- platelet activation and platelet reactivity at physical rest
- 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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Vienna, Austria, 1090
- MUVienna
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Interval
2x / week INT 2x / week CONT |
Pmax*: Maximal power output (Watt) achieved at the end of an incremental exercise test.
Other Names:
Pmax*: Maximal power output (Watt) achieved at the end of an incremental exercise test.
Other Names:
|
Active Comparator: Continuous
4x / week CONT
|
Pmax*: Maximal power output (Watt) achieved at the end of an incremental exercise test.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
12 weeks
|
Cardiorespiratory fitness: Maximal power output
Time Frame: 6 weeks
|
Maximal power output (Watt / kg bodyweight) at the end of an incremental exercise test
|
6 weeks
|
Cardiorespiratory fitness: Maximal power output
Time Frame: 12 weeks
|
Maximal power output (Watt / kg bodyweight) at the end of an incremental exercise test
|
12 weeks
|
Cardiorespiratory fitness: Maximal oxygen consumption
Time Frame: 6 weeks
|
Maximal oxygen consumption (ml/min/kg bodyweight) at the end of an incremental exercise test
|
6 weeks
|
Cardiorespiratory fitness: Maximal oxygen consumption
Time Frame: 12 weeks
|
Maximal oxygen consumption (ml/min/kg bodyweight) at the end of an incremental exercise test
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stefan Heber, MD, Medical University of Vienna
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Heber 15136
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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