Remote Exercise SWEDEHEART Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-03

Study Completion Date

2028-06-01

Brief Summary

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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

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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.

Conditions

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Myocardial Infarction

Keywords

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Exercise-based cardiac rehabilitation Secondary prevention EHealth Telerehabilitation Physical fitness Health-related quality of life cost-effectiveness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention center

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.

Group Type EXPERIMENTAL

Exercise-based cardiac rehabilitation

Intervention Type OTHER

The exercise program (remote/centre-based) will be standardized. An exCR-program is defined as at least 24 supervised sessions, with a total session length of 60 minutes, for at least 3 months, with possibility to complete missed sessions the 4th month. Each exercise session includes at least 20 min of aerobic exercise, intensity 13-17 on Borg´s rating of perceived exertion (RPE)-scale ≈ 60% - 85% of VO2max or 70 - 95% of maximal heart rate. In addition, each exercise session includes 1-3 sets of 8-10 upper and/or lower limb exercises in 10-15 repetitions, 40-80% of 1 repetition maximum. Attending ≥75% of the 24 sessions over a 4-month period will be considered as successful.

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise-based cardiac rehabilitation

The exercise program (remote/centre-based) will be standardized. An exCR-program is defined as at least 24 supervised sessions, with a total session length of 60 minutes, for at least 3 months, with possibility to complete missed sessions the 4th month. Each exercise session includes at least 20 min of aerobic exercise, intensity 13-17 on Borg´s rating of perceived exertion (RPE)-scale ≈ 60% - 85% of VO2max or 70 - 95% of maximal heart rate. In addition, each exercise session includes 1-3 sets of 8-10 upper and/or lower limb exercises in 10-15 repetitions, 40-80% of 1 repetition maximum. Attending ≥75% of the 24 sessions over a 4-month period will be considered as successful.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Maria Bäck

Associate professor, physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria Back, Ass Prof

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital

Stefan James, Prof

Role: STUDY_CHAIR

Uppsala Clinial Research Center

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Maria Back, Ass Prof

Role: CONTACT

Phone: +46700895612

Reference Type BACKGROUND

PMID: 37105430 (View on PubMed)

Back M, Leosdottir M, Ekstrom M, Hambraeus K, Ravn-Fischer A, Borg S, Brosved M, Flink M, Hedin K, Lans C, Olovsson J, Urell C, Oberg B, James S. Feasibility, safety and patient perceptions of exercise-based cardiac telerehabilitation in a multicentre real-world setting after myocardial infarction-the remote exercise SWEDEHEART study. Eur Heart J Digit Health. 2025 Mar 4;6(3):508-518. doi: 10.1093/ehjdh/ztaf014. eCollection 2025 May.

Reference Type DERIVED

PMID: 40395424 (View on PubMed)

Other Identifiers

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U-2018-312

Identifier Type: -

Identifier Source: org_study_id

Remote Exercise SWEDEHEART Study

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Intervention center

Exercise-based cardiac rehabilitation

Control

Interventions

Exercise-based cardiac rehabilitation

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Sahlgrenska University Hospital

Responsible Party

Maria Bäck

Principal Investigators

Maria Back, Ass Prof

Stefan James, Prof

Locations

Södra Älvsborg Hospital

Mälarsjukhuset

Falun hospital

Gällivare Hospital

Gävle Hospital

Angered Hospital

Sahlgrenska University Hospital Östra

Sahlgrenska University Hospital

Hässleholm Hospital

Jönköping Ryhov hospital

Kalix hospital

Kalmar Hospital

Kungälv Hospital

Lindesberg Hospital

Linköping University Hospital

Ljungby Hospital

Sunderbyn hospital

Skåne University hospital

Skåne University Hospital Malmö

Östersund hospital

Södertälje Hospital

Capio St Göran Hospital

Karolinska University Hospital

Sundsvall hospital

Uppsala University Hopsital

Värnamo hospital

Countries

Central Contacts

Maria Back, Ass Prof

Elisabeth Palmcrantz Graf

Facility Contacts

Ellinor Nylund, RPT

Ellinor Nylund, RPT

Annalina Anduri Ohlsson, RPT

Lovisa Wahlen, RPT

Lovisa Wahlen, RPT

Sara Fabricius, RPT

Anna Forsgren, RPT

Aziza Ferreira, RPT

Klara Emanuelsson Hummel, RPT

Maria Bäck, PhD

Maria Back, Ass Prof

Sandra Larsson, RPT

Maria Sahlin, RPT

Maria Sahlin, RPT

Eva Öberg, RPT

Eva Öberg, RPT

Charlotta Lans, PhD

Tina Nyth Persson, RPT

Marcus Bargholtz, MSc

Sabina Borg, RPT

Sabina Borg, RPT

Jessica Olovsson, RPT

Lena Bergström, RPT

Lena Bergström, RPT