cardiovasculair disease heart disease
Conditions
Interventions
None listed
Sponsors
Isala Zwolle
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patients of 65 years or older who have accepted CR - Signed written informed consent - One of the following criteria: o Patients with an ACS, including MI and/or revascularisation within 3 months prior to the start of the CR programme o Patients that underwent a PCI within 3 months prior to the start of the CR programme o Patients that received CABG within 3 months prior to the start of the CR programme o Patients who were treated surgically or percutaneously for valvular heart disease (including (including Transcatheter Aortic Valve Implantation) within 3 months prior to the start of the CR programme o Patients with a stable angina with documented significant coronary artery disease (defined by standard non-invasive or invasive methods)
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 - Implanted cardiac device (CRT-P, ICD)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physical fitness: - Difference in peak oxygen uptake obtained from an incremental exercise test (T1-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, T2-T1) - Changes in HbA1C (T1-T0, T2-T0, T2-T1) - Changes in renal function (T1-T0, T2-T0, T2-T1) - Changes in lean body mass (T1-T0, T2-T0, T2-T1) - Changes in blood pressure (T1-T0, T2-T0, T2-T1) - 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 (T2-T0) are registered and collected by monthly telephone calls. General health: - Difference in depression score assessed by: PHQ-9 questionnaire (T1-T0, T2-T0, T2-T1) - Difference in anxiety score assessed by GAD-7 questionnaire (T1-T0, T2-T0, T2-T1) - Quality of Life: SF-36v2, difference in Physical Component Summary Score and Mental Component Summary Score (T1-T0, T2-T0, T2-T1) - Difference in dietary pattern (reflected by total score and score on individual components) assessed by Mediterranean Diet Score (T1-T0, T2-T0, T2-T1) - Care utilisation as composite endpoint of: (number of) admissions, emergency visits and cardiac interventions (PCI, CABG) (T2-T0) - 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: - The occurrence of drop-outs (including reason for drop-out) or completed CR is registered per CR programme throughout the study period. Compliance: - Percentage of attended trainin | — |
Countries
Netherlands
Outcome results
None listed