cardiovascular disease heart disease
Conditions
Interventions
Patients aged 65 years and older, who are candidate for CR, but nut opting for
regular CR are randomised in two study arms: the mCR programme for 6 months or
no mCR programme. The mCR programme invo
Sponsors
Isala Klinieken
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patients of 65 years or older who are a candidate for CR and non-voluntary to participate in the regular CR programme - Signed written informed consent - One of the following criteria: o Patients with an acute coronary syndrome, including myocardial infarction (MI) and/or revascularisation within 3 months prior to the start of the CR programme o Patients that underwent a percutaneous coronary intervention (PCI) within 3 months prior to the start of the CR programme o Patients that received coronary artery bypass grafting (CABG) within 3 months prior to the start of the CR programme
Exclusion criteria
Exclusion criteria: - Contraindication to CR - Mental impairment leading to inability to cooperate - Severe impaired ability to exercise - Signs of severe cardiac ischemia and/or a positive exercise testing on severe cardiac ischemia - Insufficient knowledge of the native language - No access, availability or insufficient knowledge of a computer with internet - Implanted cardiac device (pacemaker, ICD)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in peak oxygen uptake (VO2peak) between the end of CR programme (T1) and baseline (T0) | — |
Secondary
| Measure | Time frame |
|---|---|
| Physical fitness: - Difference in peak oxygen uptake obtained from an incremental exercise test (T2-T0) - Difference in peak oxygen uptake obtained from an incremental exercise test (T2-T1) Traditional risk factors: - Changes in lipid profile (T1-T0, T2-T0) - Changes in HbA1C (T1-T0, T2-T0) - Changes in renal function (T1-T0, T2-T0) - Changes in lean body mass (T1-T0, T2-T0) - Changes in blood pressure (T1-T0, T2-T0) - Changes in smoking habit (T2-T0) Major Adverse Cardiovascular Events (MACE): - The occurrence of events (cardiovascular (CV) mortality, all-cause mortality, near sudden cardiac death, ACS, CV intervention/surgery, CV hospital admission, CV emergency visits) as composite endpoint (T1-T2) are registered and collected by monthly telephone calls. General health: - Difference in depression score assessed by: PHQ-9 questionnaire (T1-T0, T2-T0) - Difference in anxiety score assessed by GAD-7 questionnaire (T1-T0, T2-T0) - Quality of Life: SF-36, difference in Physical Component Summary Score and Mental Component Summary Score (T1-T0, T2-T0) - Care utilisation as composite endpoint of: (number of) admissions, emergency visits and cardiac interventions (PCI, CABG) (T1-T2) - Costs of care utilisation based on activities (clinical admission days, emergency and outpatient clinic visits, GP visits for cardiac (related) complaints or issues, radiology/cardiophysiology/nuclear and laboratory tests, and cardiac interventions) registered at T0, T1 and T2 and collected by monthly telephone calls with the participants between T1 and T2 Adherence: - Number of drop-out or completed CR throughout study period. Compliance: - Compliance to usage of the smartphone (percentage of fulfilling the planned exercise sessions with mCR for at least half an hour at 5 five days per week) in the intervention group is determined for the period between baseline and 6 months. | — |
Countries
Netherlands
Outcome results
None listed