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AtherosclerosisNCT02930330

Interval Training in Cardiac Rehabilitation

A study testing INT and CONT in people with Atherosclerosis and Coronary Artery Disease, run by Medical University of Vienna at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 years and older, men only
Conditions the study is for
Atherosclerosis, Coronary Artery Disease
What is being tested?
INT and CONT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
1 siteAustria
Study dates
Oct 2015to 14 Jun 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • MUVienna

    Vienna, 1090

Other trials in Austria

About this study

Official title: Interval Training in Cardiac Rehabilitation: Effects on Cardiorespiratory Fitness and Platelet Function - A Randomized Controlled Trial

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.

Read the 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.

Being tested
INT, CONT
Keywords
Exercise, Interval training, Blood platelets, Platelet function tests, Physical fitness, Rehabilitation
Medical subject headings
Atherosclerosis, Coronary Artery Disease, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INTBehavioural

    Also called High intensity interval training

    • 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.

  • CONTBehavioural

    Also called Moderate intensity continuous training

    • 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.

Study groups in NCT02930330
Study groupRoleWhat they receive
IntervalExperimental2x / week INT 2x / week CONT
Receives: Behavioral: INT; Behavioral: CONT
ContinuousActive comparator4x / week CONT
Receives: Behavioral: CONT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Platelet reactivity at physical rest: EC50 of TRAP-6 in terms of platelet CD62P expression. Unit of Measure: µM (Micromolar)

    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.

    Measured: 6 weeks

Secondary outcomes (5)

  1. Platelet reactivity at physical rest: EC50 of TRAP-6 in terms of platelet CD62P expression. Unit of Measure: µM

    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.

    Measured: 12 weeks

  2. Cardiorespiratory fitness: Maximal power output

    Maximal power output (Watt / kg bodyweight) at the end of an incremental exercise test

    Measured: 6 weeks

  3. Cardiorespiratory fitness: Maximal power output

    Maximal power output (Watt / kg bodyweight) at the end of an incremental exercise test

    Measured: 12 weeks

  4. Cardiorespiratory fitness: Maximal oxygen consumption

    Maximal oxygen consumption (ml/min/kg bodyweight) at the end of an incremental exercise test

    Measured: 6 weeks

  5. Cardiorespiratory fitness: Maximal oxygen consumption

    Maximal oxygen consumption (ml/min/kg bodyweight) at the end of an incremental exercise test

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2016 (estimated)
  2. Study startOct 2015
  3. Primary completion14 Jun 2017
  4. Study completion14 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02930330
Sponsor's protocol ID
Heber 15136
Status last verified
Aug 2017
First submitted
7 Oct 2016
Last updated
31 Aug 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

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.

    PubMed 22508693

  • 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.

    PubMed 26909532

  • 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.

    PubMed 31315940

Questions about this trial

What is this clinical trial studying?

A study testing INT and CONT in people with Atherosclerosis and Coronary Artery Disease, run by Medical University of Vienna at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Platelet reactivity at physical rest: EC50 of TRAP-6 in terms of platelet CD62P expression. Unit of Measure: µM (Micromolar) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02930330, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2017; AzTrials last refreshed its copy on 2 Nov 2026.

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