NCT04260958

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for not_applicable

Timeline
25mo left

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

26 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Feb 2020Jun 2028

Study Start

First participant enrolled

February 3, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 4, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 7, 2020

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Expected
Last Updated

December 5, 2024

Status Verified

December 1, 2024

Enrollment Period

5.3 years

First QC Date

February 4, 2020

Last Update Submit

December 2, 2024

Conditions

Myocardial Infarction

Keywords

Exercise-based cardiac rehabilitationSecondary preventionEHealthTelerehabilitationPhysical fitnessHealth-related quality of lifecost-effectiveness

Outcome Measures

Primary Outcomes (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.

    3-4 months

Secondary Outcomes (13)

  • Submaximal exercise capacity

    3-4 months

  • Muscular endurance tests

    3-4 months

  • Self-reported physical activity and exercise

    3-4 months

  • Self-reported physical activity and exercise Haskell

    3-4 months

  • Self-reported physical capacity

    3-4 months

  • +8 more secondary outcomes

Study Arms (2)

Intervention center

EXPERIMENTAL

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.

Other: Exercise-based cardiac rehabilitation

Control

NO INTERVENTION

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.

Interventions

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.

Intervention center

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

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

Malmo, 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

Related Publications (2)

  • 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.

    PMID: 37105430BACKGROUND

  • 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.

    PMID: 40395424DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Maria Back, Ass Prof

    Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

  • Stefan James, Prof

    Uppsala Clinial Research Center

    STUDY CHAIR

Central Study Contacts

Maria Back, Ass Prof

CONTACT

+46700895612maria.m.back@vgregion.se

Elisabeth Palmcrantz Graf

CONTACT

+46186119542elisabeth.palmcrantz-graf@ucr.uu.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, physiotherapist

Study Record Dates

First Submitted

February 4, 2020

First Posted

February 7, 2020

Study Start

February 3, 2020

Primary Completion

June 1, 2025

Study Completion (Estimated)

June 1, 2028

Last Updated

December 5, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

SE(26)