Remote Exercise SWEDEHEART Study - a Multicentre Registry-based Cluster Randomized Crossover Clinical Trial (RRCT)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Myocardial Infarction
- Sponsor
- Sahlgrenska University Hospital, Sweden
- Enrollment
- 1500
- Locations
- 26
- Primary Endpoint
- Mean number of exCR sessions
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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).
Detailed 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.
Investigators
Maria Bäck
Associate professor, physiotherapist
Sahlgrenska University Hospital, Sweden
Eligibility 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
Outcomes
Primary Outcomes
Mean number of exCR sessions
Time Frame: 3-4 months
The primary outcome is the mean number of EBCR sessions (center based or remote) during 0-4 months (from start of the EBCR program) for patients at a center during each randomization period. Eligible patients that have not started the EBCR program within 6 months of screening will be counted as 0 sessions. Attending ≥75% of the 24 recommended sessions over a 4-month period will be considered as completion, and proportion completers will be presented in a supportive responder analysis.
Secondary Outcomes
- Health-related quality of life VAS(3-4 months)
- Self-reported perceptions on exercise(3-4 months)
- Self-reported physical activity and exercise(3-4 months)
- Self-reported physical activity and exercise Haskell(3-4 months)
- Submaximal exercise capacity(3-4 months)
- Muscular endurance tests(3-4 months)
- Self-reported physical capacity(3-4 months)
- Self-efficacy for Exercise Scale(3-4 months)
- Kinesiophobia (fear of movement)(3-4 months)
- Cost-effectiveness(End of study)
- Number of Cardiovascular events(1 and 3 years after the last patient visit)
- Health-related quality of life EQ5D(3-4 months)
- Socio-economic evaluation(6 years)