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The remote exercise SWEDEHEART study–Rationale and design of a multicenter registry-based cluster randomized crossover clinical trial (RRCT) - 12/06/23

Doi : 10.1016/j.ahj.2023.04.014 
Maria Bäck, RPT, PhD a, b, c, , Margret Leosdottir, MD, PhD d, e, Mattias Ekström, MD, PhD f, Kristina Hambraeus, MD, PhD g, Annica Ravn-Fischer, MD, PhD b, Birgitta Öberg, RPT, PhD c, Ollie Östlund, PhD h, Stefan James, MD, PhD h, i
a Department of Occupational Therapy and Physiotherapy, Sahlgrenska University Hospital, Gothenburg, Sweden 
b Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden 
c Department of Medical and Health Sciences, Division of Physiotherapy, Linköping University, Linköping, Sweden 
d Department of Cardiology, Skåne University Hospital, Malmö, Sweden 
e Department of Clinical Sciences Malmö, Lund University, Malmö, Sweden 
f Division of Cardiovascular Medicine, Department of Clinical Sciences, Danderyd Hospital, Stockholm, Sweden 
g Department of Cardiology, Falu Hospital, Falun, Sweden 
h Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden 
i Department of Medical Sciences, Uppsala University, Uppsala, Sweden 

Reprint requests: Maria Bäck, RPT, PhD, Department of Physiotherapy, Sahlgrenska University Hospital, Vita Stråket 13, 413 45 Gothenburg, Sweden.Department of PhysiotherapySahlgrenska University HospitalVita Stråket 13Gothenburg413 45Sweden

Riassunto

Background

Despite proven benefits of exercise-based cardiac rehabilitation (EBCR), few patients with myocardial infarction (MI) participate in and complete these programs.

Study design and objectives

The Remote Exercise SWEDEHEART study is a large multicenter registry-based cluster randomized crossover clinical trial with a planned enrollment of 1500 patients with a recent MI. Patients at intervention centers will be offered supervised EBCR, either delivered remotely, center-based or as a combination of both modes, as self-preferred choice. At control centers, patients will be offered supervised center-based EBCR, only. The duration of each time period (intervention/control) for each center will be 15 months and then cross-over occurs. The primary aim is to evaluate if remotely delivered EBCR, offered as an alternative to center-based EBCR, can increase participation in EBCR sessions. The proportion completers in each group will be presented in a supportive responder analysis. The key secondary aim is to investigate if remote EBCR is as least as effective as center-based EBCR, in terms of physical fitness and patient-reported outcome measures. Follow-up of major adverse cardiovascular events (cardiovascular- and all-cause mortality, recurrent hospitalization for acute coronary syndrome, heart failure hospitalization, stroke, and coronary revascularization) will be performed at 1 and 3 years. Safety monitoring of serious adverse events will be registered, and a cost-effectiveness analysis will be conducted to estimate the cost per quality-adjusted life-year (QALY) associated with the intervention compared with control.

Conclusions

The cluster randomized crossover clinical trial Remote Exercise SWEDEHEART study is evaluating if participation in EBCR sessions can be increased, which may contribute to health benefits both on a group level and for individual patients including a more equal access to health care.

Trial registration

The study is registered at ClinicalTrials.gov (Identifier: NCT04260958)

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Vol 262

P. 110-118 - agosto 2023 Ritorno al numero
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