Randomized Clinical Trial for optimal Cardiac Rehabilitation: A traditional Dutch Cardiac Rehabilitation Program versus a Canadian High Efficiency Cardiac Rehabilitation Program

Randomized Clinical Trial for optimal Cardiac Rehabilitation: A traditional Dutch Cardiac Rehabilitation Program versus a Canadian High Efficiency Cardiac Rehabilitation Program - Cardiac Rehabilitation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36989

Enrollment

210

Registered

2012-07-31

Start date

2013-03-01

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coronary syndrome heart attack

Interventions

Patients in the (HR)2 program will undergo 18 months of an individually tailored exercise training, i.e. walking and jogging at a moderate intensity. The outcomes of the maximal exercise tests will

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients suitable for cardiac rehabilitation - Signed written informed consent - One of the following criteria: * Patients with an acute coronary syndrome, including myocardial infarction (MI) within 3 months prior to inclusion * Patients that underwent a percutaneous coronary intervention (PCI) within 3 months prior to inclusion * Patients that received coronary artery bypass grafting (CABG) within 3 months prior to inclusion

Exclusion criteria

Exclusion criteria: - Mental impairment leading to inability to cooperate - Severe impaired ability to exercise of other than cardiovascular causes - Signs of cardiac ischemia and/or a positive exercise testing on cardiac ischemia - Insufficient knowledge of the Dutch language

Design outcomes

Primary

Measure	Time frame
Physical capacity (peak oxygen uptake)	—

Secondary

Measure	Time frame
- Six minutes walking test [maximum walking distance] - Vascular structure and function (conduit artery endothelial function, conduit artery diameter, blood flow, IMT, conduit and resistance artery structure, peak hypereamic blood flow, exercise-induced vasodilation, pulse wave velocity) - Cardiac structure and function (cardiac mass and dimensions, systolic and diastolic function parameters, left and right ventricle strain rate) - Plaque testing (carotid, femoral and brachial arteries). - PLAC test (Lp-PLA2) - Activities of daily living (ADL) - Cardiovascular Lifetime Score (http://www.lifetimerisk.org) - Major Cardiovascular Adverse Events (cardiovascular (CV) mortality, all cause mortality, near sudden cardiac death, acute coronary syndrome, CV intervention/surgery, CV hospital admission, CV Emergency visits) - Quality of life (SF-12, DS-14, GMS, EDS-extended questionnaire) - Traditional risk factors (i.e. cholesterol, lipid profile, APOB, HbA1C, Vitamin D3, insulin sensitivity, blood pressure, and body characteristics) - Care consumption (medication, relapse, (days) admission, outpatient clinic visits, GP visits, interventions, radiology, nuclear and lab testing).	—

Measure

Time frame

- Six minutes walking test [maximum walking distance] - Vascular structure and function (conduit artery endothelial function, conduit artery diameter, blood flow, IMT, conduit and resistance artery structure, peak hypereamic blood flow, exercise-induced vasodilation, pulse wave velocity) - Cardiac structure and function (cardiac mass and dimensions, systolic and diastolic function parameters, left and right ventricle strain rate) - Plaque testing (carotid, femoral and brachial arteries). - PLAC test (Lp-PLA2) - Activities of daily living (ADL) - Cardiovascular Lifetime Score (http://www.lifetimerisk.org) - Major Cardiovascular Adverse Events (cardiovascular (CV) mortality, all cause mortality, near sudden cardiac death, acute coronary syndrome, CV intervention/surgery, CV hospital admission, CV Emergency visits) - Quality of life (SF-12, DS-14, GMS, EDS-extended questionnaire) - Traditional risk factors (i.e. cholesterol, lipid profile, APOB, HbA1C, Vitamin D3, insulin sensitivity, blood pressure, and body characteristics) - Care consumption (medication, relapse, (days) admission, outpatient clinic visits, GP visits, interventions, radiology, nuclear and lab testing).

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)