The remote exercise SWEDEHEART study–Rationale and design of a multicenter registry-based cluster randomized crossover clinical trial (RRCT)
Study context
- Population
- Patients with a recent myocardial infarction (MI)planned enrolment 1500
- Planned comparison
- Remote exercise-based cardiac rehabilitation (EBCR) offered as an alternative to centre-based EBCR vs centre-based EBCR only
- Primary endpoint
- Participation in EBCR sessions
Methodological detailsmulticentre, Each centre's intervention/control period lasts 15 months, then crossover, Key secondary aim: whether remote EBCR is at least as effective as centre-based EBCR for physical fitness and patient-reported outcomes, MACE follow-up at 1 and 3 years; serious AE monitoring; cost per quality-adjusted life-year (QALY) analysis
- Multicentre
- Each centre's intervention/control period lasts 15 months, then crossover
- Key secondary aim: whether remote EBCR is at least as effective as centre-based EBCR for physical fitness and patient-reported outcomes
- MACE follow-up at 1 and 3 years; serious AE monitoring; cost per QALY analysis
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
The remote exercise SWEDEHEART study–Rationale and design of a multicenter registry-based cluster randomized crossover clinical trial (RRCT). Am Heart J. Published 25 April 2023. doi:10. 1016/ j. ahj. 2023. 04. 014
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