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Remote Exercise SWEDEHEART Study

Recruiting
18 - 79 years of age
Both
Phase N/A

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Overview

The overall aim of the study is to evaluate if remote video exercise-based cardiac rehabilitation (exCR), offered as an alternative to centre-based exCR, can increase participation in exCR sessions post myocardial infarction (MI).

Description

Due to the covid-19 pandemic, this study will be performed in two steps:

1). National feasibility and safety study. 2). National multicenter registry-based cluster randomized crossover clinical trial (RRCT).

  1. In the feasibility study, patients will be offered remote exCR at all participating sites until the peak of the pandemic has been achieved and care goes back to normal. The feasibility study will include patients until Aug 2022.
  2. CR centers (not patients) will be cluster randomized to either the intervention or control. Patients at intervention centers will be offered remote exCR, usual care centre-based exCR, or a combination of both modes, as self-preferred choice. At control centers, patients will be offered usual care centre-based exCR only. The duration of each time period for each center will be 15 months. Long-term follow-up will be performed 1 year and 3 years after the index cardiac event.

Eligibility

Inclusion Criteria:

  • Written informed consent
  • Diagnosis of type 1 myocardial infarction (AMI)
  • Age 18-79 years at discharge from hospital

Exclusion Criteria:

  • Patients with incomplete coronary revascularization defined as at least one remaining hemodynamically significant stenosis
  • Severe valve or structural heart disease
  • Severe heart failure (NYHA III - IV)
  • Serious arrythmias
  • Inability to understand Swedish
  • No internet access at home (only applicable for patients in the intervention group who wants to perform remote exCR)
  • Pathological exercise test indicating high risk for adverse events during exCR
  • More than 6 months between discharge form hospital and screening
  • Any other condition that may interfere with the possibility for the patient to comply with the study protocol

Study details

Myocardial Infarction

NCT04260958

Sahlgrenska University Hospital, Sweden

25 January 2024

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