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Myocardial InfarctionNCT04260958

Remote Exercise SWEDEHEART Study

A study testing Exercise-based cardiac rehabilitation in people with Myocardial Infarction, run by Sahlgrenska University Hospital at 25 sites in Sweden.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
Myocardial Infarction
What is being tested?
Exercise-based cardiac rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,500 participants
Where
25 sitesSweden
Study dates
3 Feb 2020to 1 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent
  • Diagnosis of type 1 myocardial infarction (AMI)
  • Age 18-79 years at discharge from hospital

Who cannot join

  • 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)
Show all 9Show fewer
  • 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 locations and contacts

25 sites in 1 country.

25 sites in 1 country

Sweden25 sites

  • Södra Älvsborg Hospital

    Borås

  • Mälarsjukhuset

    Eskilstuna

  • Falun hospital

    Falun

  • Gällivare Hospital

    Gällivare

  • Gävle Hospital

    Gävle

  • Angered Hospital

    Gothenburg

  • Sahlgrenska University Hospital Östra

    Gothenburg

  • Sahlgrenska University Hospital

    Gothenburg

  • Hässleholm Hospital

    Hässleholm

  • Jönköping Ryhov hospital

    Jönköping

  • Kalix hospital

    Kalix

  • Kalmar Hospital

    Kalmar

  • Kungälv Hospital

    Kungälv

  • Lindesberg Hospital

    Lindesberg

  • Linköping University Hospital

    Linköping

  • Ljungby Hospital

    Ljungby

  • Sunderbyn hospital

    Luleå

  • Skåne University hospital

    Lund

  • Skåne University Hospital Malmö

    Malmö

  • Östersund hospital

    Östersund

  • Capio St Göran Hospital

    Stockholm

  • Karolinska University Hospital

    Stockholm

  • Sundsvall hospital

    Sundsvall

  • Uppsala University Hopsital

    Uppsala

  • Värnamo hospital

    Värnamo

Other trials in Sweden

About this study

Official title: Remote Exercise SWEDEHEART Study - a Multicentre Registry-based Cluster Randomized Crossover Clinical Trial (RRCT)

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).

Read the 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.
Being tested
Exercise-based cardiac rehabilitation
Keywords
Exercise-based cardiac rehabilitation, Secondary prevention, EHealth, Telerehabilitation, Physical fitness, Health-related quality of life, cost-effectiveness
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise-based cardiac rehabilitationOther

    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.

Study groups in NCT04260958
Study groupRoleWhat they receive
Intervention centerExperimentalPatients 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.
Receives: Other: Exercise-based cardiac rehabilitation
ControlNo interventionAt 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean number of exCR sessions

    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.

    Measured: 3-4 months

Secondary outcomes (13)

  1. Submaximal exercise capacity

    Bicycle ergometer test according to the WHO-protocol with an increased workload of 25W every 4.5 minutes. The exercise test is discontinued at Borg RPE 17 and/or dyspnea 7 at Borg´s CR-10 scale.

    Measured: 3-4 months

  2. Muscular endurance tests

    Unilateral isotonic shoulder flexion (maximum number of repetitions) and a unilateral isotonic heel lift (maximum number of repetitions)

    Measured: 3-4 months

  3. Self-reported physical activity and exercise

    Two questions on physical activity and exercise during the latest week according to Haskell´s questionnaire (Min:0, Max:7). Ordinal scale, number of days.

    Measured: 3-4 months

  4. Self-reported physical activity and exercise Haskell

    Haskell´s questionnaire (Min:0, Max:7). A high score means higher level of physical activity and exercise.

    Measured: 3-4 months

  5. Self-reported physical capacity

    Visual analog scale, (100=best possible physical capacity, 0=worst possible physical capacity), a dichotomous question: Do you experience any limitation in everyday life due to your current physical capacity? (yes vs no). If yes: multiple choice on reasons

    Measured: 3-4 months

  6. Health-related quality of life EQ5D

    Euro Quality of Life (EQ-5D 3L). The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. A high score indicates better Health.

    Measured: 3-4 months

  7. Health-related quality of life VAS

    Euro Quality of Life VAS. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state'(100) and 'Worst imaginable health state' (0)

    Measured: 3-4 months

  8. Kinesiophobia (fear of movement)

    Tampa Scale for Kinesiophobia Heart (17 items, ordinal scale 1-4) 1, strongly disagree, 4, strongly agree. A higher score is means higher values of kinesiophobia (worse).

    Measured: 3-4 months

  9. Self-efficacy for Exercise Scale

    Self-efficacy for Exercise Scale. 9 items, ordinal scale. 0=not Confident, 10=very Confident. Total score is calculated by summing the responses to each question. This scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise

    Measured: 3-4 months

  10. Self-reported perceptions on exercise

    Patient´s perceptions of remote exCR or centre-based exCR. 1, strongly disagree, 4, strongly agree. This questionnarie is designed by the authors. High score, better outcome.

    Measured: 3-4 months

  11. Cost-effectiveness

    A cost-effectiveness analysis will be performed in order to estimate the cost per quality-adjusted life-year (QALY) associated with the intervention compared with control. Healthcare costs associated with investigated treatments will be assessed by extracting resource use from the relevant registries, and QALYs will be determined by combining survival status and the quality-of-life measurements provided by the EQ-5D-3L instrument.

    Measured: End of study

  12. Socio-economic evaluation

    Data from Statistics Sweden will be used to evaluate study results in relation to socio-economic data

    Measured: 6 years

  13. Number of Cardiovascular events

    All-cause mortality, cardiovascular mortality, recurrent hospitalization for ACS, heart failure hospitalization, stroke and repeat coronary revascularization, reported in SWEDEHEART, the National Patient Registry and the Cause of Death Register will be performed.

    Measured: 1 and 3 years after the last patient visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2020
  2. Study start3 Feb 2020
  3. Primary completion1 Jun 2025
  4. Study completion1 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
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.
Masking
None (open label)
Enrolment
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04260958
Sponsor's protocol ID
U-2018-312
Status last verified
Jul 2026
First submitted
4 Feb 2020
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37105430

  • 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.

    PubMed 40395424

Questions about this trial

What is this clinical trial studying?

A study testing Exercise-based cardiac rehabilitation in people with Myocardial Infarction, run by Sahlgrenska University Hospital at 25 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean number of exCR sessions (time frame: 3-4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04260958, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.

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