The remote exercise SWEDEHEART study–Rationale and design of a multicenter registry-based cluster randomized crossover clinical trial (RRCT)
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Key result
Ongoing trial tests whether remote cardiac rehab boosts post-MI session participation.
- n=1,500
Why the study?
Despite the proven benefits of exercise-based cardiac rehabilitation (EBCR), few patients with myocardial infarction participate in and complete these programs.
Does offering remotely delivered exercise-based cardiac rehabilitation (EBCR) as an alternative or combination with center-based EBCR increase participation in EBCR sessions compared to offering center-based EBCR only in patients with a recent myocardial infarction?
Study Design
Type
RCT (n=1,500)
Blinding
Open-label
Randomization
Cluster randomized crossover
Multicenter
Yes
Structured PICO
Does offering remotely delivered exercise-based cardiac rehabilitation (EBCR) as an alternative or combination with center-based EBCR increase participation in EBCR sessions compared to offering center-based EBCR only in patients with a recent myocardial infarction?
P
Population
Planned enrollment of 1,500 adults aged 18-79 years with a recent myocardial infarction across 27 Swedish cardiac rehabilitation centers, followed for 1 and 3 years for major adverse cardiovascular events.
I
Intervention
Supervised exercise-based cardiac rehabilitation (EBCR) offered as a self-preferred choice of remotely delivered (via real-time group-based video meeting led by a hospital physiotherapist), center-based, or a combination of both modes, consisting of individually tailored aerobic and strength exercises 2 times a week for 3-4 months, plus one additional home-based session of at least 30 minutes of aerobic exercise per week.
C
Comparator
Supervised center-based exercise-based cardiac rehabilitation (EBCR) only, consisting of individually tailored aerobic and strength exercises 2 times a week for 3-4 months, plus one additional home-based session of at least 30 minutes of aerobic exercise per week.
O
Outcome
Mean number of EBCR sessions (center-based or remote) during 0-4 months from the start of the EBCR program, aggregated for each center-period (with proportion of completers attending ≥75% of the 24 recommended sessions presented in a supportive responder analysis).
This study describes the rationale and design of a pragmatic, multicenter, registry-based cluster randomized crossover trial evaluating whether offering remote exercise-based cardiac rehabilitation increases program participation and maintains physical fitness compared to center-based rehabilitation alone in post-MI patients.
Limitations
- This is a study protocol and rationale paper with no clinical outcome results reported yet
- The number of centers and trial duration are mainly limited by feasibility
- The trial is not well-powered for major adverse cardiovascular events and death
- The number of centers and the trial duration are mainly limited by feasibility.
- The trial will not be well-powered for MACE and death, so these outcomes are not included in a formal test family with protected type 1 error.
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Our findings suggest that remotely delivered exercise-based cardiac rehabilitation should be viewed as an additional patient-centred option, rather than a replacement for centre-based rehabilitation or a stand-alone solution for poor uptake. It appears that there are other participation barriers that are not related to travelling, which may include other co-existing diseases, language barriers, socioeconomic factors and varying levels of digital health literacy.”
“This suggests that remote exercise was a relevant option for a substantial proportion of patients, even though it did not increase overall participation at a population level.”
Implication
This ongoing trial will test whether remote EBCR boosts post-MI participation; leaves open effects on fitness and outcomes until results are reported.
Abstract
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).
Coverage & sources
Journal, society, and media accounts. Useful signal, not independent expert judgment.
Discussion
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Cite This Study
Bäck et al. (2023) conducted an RCT in Recent myocardial infarction (n=1,500). Supervised exercise-based cardiac rehabilitation (remote, center-based, or combined as self-preferred choice) vs. Supervised center-based exercise-based cardiac rehabilitation only was evaluated on Mean number of completed exercise-based cardiac rehabilitation sessions during 0-4 months. Remotely delivered exercise-based cardiac rehabilitation is being evaluated in an ongoing 1,500-patient cluster-randomized trial to determine if it increases session participation after MI.
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