Interval Training in Cardiac Rehabilitation

NCT02930330 | Completed

• 1 other identifier: Heber 15136
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerosis; Coronary Artery Disease

Keywords

Exercise; Interval training; Blood platelets; Platelet function tests; Physical fitness; Rehabilitation

Outcome Measures

Primary Outcomes (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.

  6 weeks

Secondary Outcomes (5)

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

  12 weeks

• Cardiorespiratory fitness: Maximal power output

  6 weeks

• Cardiorespiratory fitness: Maximal power output

  12 weeks

• Cardiorespiratory fitness: Maximal oxygen consumption

  6 weeks

• Cardiorespiratory fitness: Maximal oxygen consumption

  12 weeks

Study Arms (2)

Interval

EXPERIMENTAL

2x / week INT 2x / week CONT

Behavioral: INT; Behavioral: CONT

Continuous

ACTIVE COMPARATOR

4x / week CONT

Behavioral: CONT

Interventions

INT BEHAVIORAL

* 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.

Also known as: High intensity interval training

Interval

CONT BEHAVIORAL

* 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.

Also known as: Moderate intensity continuous training

Continuous; Interval

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead
• Medical Scientific Fund of the Mayor of Vienna: collaborator
• Austrian Heart Funds: collaborator

Study Sites (1)

MUVienna

Vienna, 1090, Austria

Location

Related Publications (3)

• 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.

  PMID: 22508693 BACKGROUND

• 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.

  PMID: 26909532 BACKGROUND

• 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.

  PMID: 31315940 DERIVED

MeSH Terms

Conditions

Atherosclerosis; Coronary Artery Disease; Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Stefan Heber, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Med. Univ.

Study Record Dates

• First Submitted: October 7, 2016
• First Posted: October 12, 2016
• Study Start: October 1, 2015
• Primary Completion: June 14, 2017
• Study Completion: June 14, 2017
• Last Updated: August 31, 2017

Record last verified: 2017-08

Locations

AU (1)