Remote Exercise SWEDEHEART Study

Last updated: December 2, 2024
Sponsor: Sahlgrenska University Hospital, Sweden
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cardiovascular Disease

Blood Clots

Congestive Heart Failure

Treatment

Exercise-based cardiac rehabilitation

Clinical Study ID

NCT04260958
U-2018-312
  • Ages 18-79
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Written informed consent

  • Diagnosis of type 1 myocardial infarction (AMI)

  • Age 18-79 years at discharge from hospital

Exclusion

Exclusion Criteria:

  • Patients with incomplete coronary revascularization defined as at least oneremaining 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 groupwho 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 tocomply with the study protocol

Study Design

Total Participants: 1500
Treatment Group(s): 1
Primary Treatment: Exercise-based cardiac rehabilitation
Phase:
Study Start date:
February 03, 2020
Estimated Completion Date:
June 01, 2028

Study 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.

Connect with a study center

  • Södra Älvsborg Hospital

    Borås,
    Sweden

    Active - Recruiting

  • Eksjö Hospital

    Eksjö,
    Sweden

    Site Not Available

  • Mälarsjukhuset

    Eskilstuna,
    Sweden

    Active - Recruiting

  • Falun hospital

    Falun,
    Sweden

    Active - Recruiting

  • Angered Hospital

    Gothenburg,
    Sweden

    Active - Recruiting

  • Sahlgrenska University Hospital

    Gothenburg,
    Sweden

    Active - Recruiting

  • Sahlgrenska University Hospital Östra

    Gothenburg,
    Sweden

    Active - Recruiting

  • Gällivare Hospital

    Gällivare,
    Sweden

    Active - Recruiting

  • Gävle Hospital

    Gävle,
    Sweden

    Active - Recruiting

  • Halmstad hospital

    Halmstad,
    Sweden

    Site Not Available

  • Hudiksvall hospital

    Hudiksvall,
    Sweden

    Site Not Available

  • Hässleholm Hospital

    Hässleholm,
    Sweden

    Active - Recruiting

  • Jönköping Ryhov hospital

    Jönköping,
    Sweden

    Active - Recruiting

  • Kalix hospital

    Kalix,
    Sweden

    Active - Recruiting

  • Kalmar Hospital

    Kalmar,
    Sweden

    Active - Recruiting

  • Kungälv Hospital

    Kungälv,
    Sweden

    Active - Recruiting

  • Lindesberg Hospital

    Lindesberg,
    Sweden

    Active - Recruiting

  • Linköping University Hospital

    Linköping,
    Sweden

    Active - Recruiting

  • Ljungby Hospital

    Ljungby,
    Sweden

    Active - Recruiting

  • Sunderbyn hospital

    Luleå,
    Sweden

    Active - Recruiting

  • Skåne University hospital

    Lund,
    Sweden

    Active - Recruiting

  • Skåne University Hospital Malmö

    Malmö,
    Sweden

    Active - Recruiting

  • Norrköping Vrinnevi hospital

    Norrköping,
    Sweden

    Site Not Available

  • Oskarshamn hospital

    Oskarshamn,
    Sweden

    Site Not Available

  • Skaraborg hospital

    Skövde,
    Sweden

    Site Not Available

  • Capio St Göran Hospital

    Stockholm,
    Sweden

    Active - Recruiting

  • Karolinska University Hospital

    Stockholm,
    Sweden

    Active - Recruiting

  • Sundsvall hospital

    Sundsvall,
    Sweden

    Active - Recruiting

  • Södertälje Hospital

    Södertälje,
    Sweden

    Active - Recruiting

  • NU-sjukvården

    Trollhättan,
    Sweden

    Site Not Available

  • Uppsala University Hopsital

    Uppsala,
    Sweden

    Active - Recruiting

  • Visby Hospital

    Visby,
    Sweden

    Site Not Available

  • Värnamo hospital

    Värnamo,
    Sweden

    Terminated

  • Östersund hospital

    Östersund,
    Sweden

    Active - Recruiting

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