Remote Exercise SWEDEHEART Study

Sahlgrenska University Hospital

Status: Enrolling

Conditions: Myocardial Infarction

Treatments: Other: Exercise-based cardiac rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT04260958

U-2018-312

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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1,500 participants in 2 patient groups

Intervention center

Experimental group

Description:

Patients at intervention centers will be offered remote video exCR (first-hand option), usual care centre-based exCR or a combination. The exercise program (remote/centre-based) will be standardized and performed for totally 60 minutes, 2 times a week for 3 months. Exercise will be individually prescribed and progressed by physiotherapists in accordance with guidelines. Patients will also be asked to perform one additional session of at least 30 min aerobic exercise per week, at intensity level 13-15 according to Borg RPE-scale.

Treatment:

Other: Exercise-based cardiac rehabilitation

Control

No Intervention group

Description:

At control centers, patients will be offered usual care centre-based exCR only. Patients will also be asked to perform one additional session of at least 30 min aerobic exercise per week, at intensity level 13-15 according to Borg RPE-scale.