Remote exercise program for heart rehabilitation after a heart attack
Remote Exercise SWEDEHEART Study - a Multicentre Registry-based Cluster Randomized Crossover Clinical Trial (RRCT)
This study tests if a remote video exercise program can help people recover after a heart attack just as well as traditional in-person rehab.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1500 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | Sahlgrenska University Hospital Academic / other |
| Locations | 26 sites (Borås and 25 other locations) |
| Trial ID | NCT04260958 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of remote video exercise-based cardiac rehabilitation (exCR) as an alternative to traditional center-based rehabilitation for patients recovering from a myocardial infarction. It consists of two phases: a national feasibility study to assess safety and participation during the COVID-19 pandemic, followed by a multicenter randomized crossover trial comparing remote and center-based rehabilitation options. Patients will have the choice of participating in remote exCR, traditional rehabilitation, or a combination of both, with long-term follow-up planned for one and three years post-event.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-79 who have experienced a type 1 myocardial infarction and can provide informed consent.
Not a fit: Patients with severe heart conditions, significant arrhythmias, or those lacking internet access for remote participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly increase patient participation in cardiac rehabilitation, leading to improved recovery outcomes after a heart attack.
How similar studies have performed: Other studies have shown promising results with remote rehabilitation approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Borås and 25 other locations
- Södra Älvsborg Hospital — Borås, Sweden (Recruiting)
- Mälarsjukhuset — Eskilstuna, Sweden (Recruiting)
- Falun hospital — Falun, Sweden (Recruiting)
- Gällivare Hospital — Gällivare, Sweden (Recruiting)
- Gävle Hospital — Gävle, Sweden (Recruiting)
- Angered Hospital — Gothenburg, Sweden (Recruiting)
- Sahlgrenska University Hospital Östra — Gothenburg, Sweden (Recruiting)
- Sahlgrenska University Hospital — Gothenburg, Sweden (Recruiting)
- Hässleholm Hospital — Hässleholm, Sweden (Recruiting)
- Jönköping Ryhov hospital — Jönköping, Sweden (Recruiting)
- Kalix hospital — Kalix, Sweden (Recruiting)
- Kalmar Hospital — Kalmar, Sweden (Recruiting)
- Kungälv Hospital — Kungälv, Sweden (Recruiting)
- Lindesberg Hospital — Lindesberg, Sweden (Recruiting)
- Linköping University Hospital — Linköping, Sweden (Recruiting)
- Ljungby Hospital — Ljungby, Sweden (Recruiting)
- Sunderbyn hospital — Luleå, Sweden (Recruiting)
- Skåne University hospital — Lund, Sweden (Recruiting)
- Skåne University Hospital Malmö — Malmö, Sweden (Recruiting)
- Östersund hospital — Östersund, Sweden (Recruiting)
- Södertälje Hospital — Södertälje, Sweden (Recruiting)
- Capio St Göran Hospital — Stockholm, Sweden (Recruiting)
- Karolinska University Hospital — Stockholm, Sweden (Recruiting)
- Sundsvall hospital — Sundsvall, Sweden (Recruiting)
- Uppsala University Hopsital — Uppsala, Sweden (Recruiting)
- Värnamo hospital — Värnamo, Sweden (Terminated)
Study contacts
- Principal investigator: Maria Back, Ass Prof — Sahlgrenska University Hospital
- Study coordinator: Maria Back, Ass Prof
- Email: maria.m.back@vgregion.se
- Phone: +46700895612
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.