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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT02930330
Date of registration: 07/10/2016
Prospective Registration: No
Primary sponsor: Medical University of Vienna
Public title: Interval Training in Cardiac Rehabilitation
Scientific title: Interval Training in Cardiac Rehabilitation: Effects on Cardiorespiratory Fitness and Platelet Function - A Randomized Controlled Trial
Date of first enrolment: October 2015
Target sample size: 82
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02930330
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Austria
Contacts
Name:     Stefan Heber, MD
Address: 
Telephone:
Email:
Affiliation:  Medical University of Vienna
Key inclusion & exclusion 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



Age minimum: 45 Years
Age maximum: N/A
Gender: Male
Health Condition(s) or Problem(s) studied
Atherosclerosis
Coronary Artery Disease
Intervention(s)
Behavioral: INT
Behavioral: CONT
Primary Outcome(s)
Platelet reactivity at physical rest: EC50 of TRAP-6 in terms of platelet CD62P expression. Unit of Measure: µM (Micromolar) [Time Frame: 6 weeks]
Secondary Outcome(s)
Cardiorespiratory fitness: Maximal oxygen consumption [Time Frame: 12 weeks]
Platelet reactivity at physical rest: EC50 of TRAP-6 in terms of platelet CD62P expression. Unit of Measure: µM [Time Frame: 12 weeks]
Cardiorespiratory fitness: Maximal power output [Time Frame: 12 weeks]
Cardiorespiratory fitness: Maximal oxygen consumption [Time Frame: 6 weeks]
Cardiorespiratory fitness: Maximal power output [Time Frame: 6 weeks]
Secondary ID(s)
Heber 15136
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Austrian Heart Funds
Medical Scientific Fund of the Mayor of Vienna
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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