Clinical trial NCT04260958: Remote Exercise SWEDEHEART Study
Official title: Remote Exercise SWEDEHEART Study - a Multicentre Registry-based Cluster Randomized Crossover Clinical Trial (RRCT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myocardial Infarction
Keywords: Exercise-based cardiac rehabilitation
Secondary prevention
EHealth
Telerehabilitation
Physical fitness
Health-related quality of life
cost-effectiveness
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2020-02-07
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: CR centers will be cluster randomized and start as either the intervention or control center. Patients at intervention centers will be offered remote video exCR (first-hand option), usual care centre-based exCR or a combination of these two exercise modes. 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 and then cross-over will occur, so that intervention centers become control centers and the other way around. At intervention centers, patients participating in remote exCR will finish their 3-month exercise period, but no new patients will be offered remote exCR after the cross-over has occurred.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean number of exCR sessions
timeFrame: 3-4 months
Secondary outcomes:
measure: Submaximal exercise capacity
timeFrame: 3-4 months
measure: Muscular endurance tests
timeFrame: 3-4 months
measure: Self-reported physical activity and exercise
timeFrame: 3-4 months
measure: Self-reported physical activity and exercise Haskell
timeFrame: 3-4 months
measure: Self-reported physical capacity
timeFrame: 3-4 months
measure: Health-related quality of life EQ5D
timeFrame: 3-4 months
measure: Health-related quality of life VAS
timeFrame: 3-4 months
measure: Kinesiophobia (fear of movement)
timeFrame: 3-4 months
measure: Self-efficacy for Exercise Scale
timeFrame: 3-4 months
measure: Self-reported perceptions on exercise
timeFrame: 3-4 months
measure: Cost-effectiveness
timeFrame: End of study
measure: Socio-economic evaluation
timeFrame: 6 years
measure: Number of Cardiovascular events
timeFrame: 1 and 3 years after the last patient visit
Other outcomes:
Locations:
city: Borås
country: Sweden
facility: Södra Älvsborg Hospital
city: Eskilstuna
country: Sweden
facility: Mälarsjukhuset
city: Falun
country: Sweden
facility: Falun hospital
city: Gothenburg
country: Sweden
facility: Angered Hospital
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital Östra
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Gällivare
country: Sweden
facility: Gällivare Hospital
city: Gävle
country: Sweden
facility: Gävle Hospital
city: Hässleholm
country: Sweden
facility: Hässleholm Hospital
city: Jönköping
country: Sweden
facility: Jönköping Ryhov hospital
city: Kalix
country: Sweden
facility: Kalix hospital
city: Kalmar
country: Sweden
facility: Kalmar Hospital
city: Kungälv
country: Sweden
facility: Kungälv Hospital
city: Lindesberg
country: Sweden
facility: Lindesberg Hospital
city: Linköping
country: Sweden
facility: Linköping University Hospital
city: Ljungby
country: Sweden
facility: Ljungby Hospital
city: Luleå
country: Sweden
facility: Sunderbyn hospital
city: Lund
country: Sweden
facility: Skåne University hospital
city: Malmö
country: Sweden
facility: Skåne University Hospital Malmö
city: Stockholm
country: Sweden
facility: Capio St Göran Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Sundsvall
country: Sweden
facility: Sundsvall hospital
city: Södertälje
country: Sweden
facility: Södertälje Hospital
city: Uppsala
country: Sweden
facility: Uppsala University Hopsital
city: Värnamo
country: Sweden
facility: Värnamo hospital
city: Östersund
country: Sweden
facility: Östersund hospital
Study officials:
affiliation: Sahlgrenska University Hospital
name: Maria Back, Ass Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Uppsala Clinial Research Center
name: Stefan James, Prof
role: STUDY_CHAIR
References:
citation: Back M, Leosdottir M, Ekstrom M, Hambraeus K, Ravn-Fischer A, Oberg B, Ostlund O, James S. The remote exercise SWEDEHEART study-Rationale and design of a multicenter registry-based cluster randomized crossover clinical trial (RRCT). Am Heart J. 2023 Aug;262:110-118. doi: 10.1016/j.ahj.2023.04.014. Epub 2023 Apr 25.