Remote Exercise SWEDEHEART Study

December 2, 2024 updated by: Maria Bäck, Sahlgrenska University Hospital, Sweden

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

1500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3-4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Submaximal exercise capacity
Time Frame: 3-4 months
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.
3-4 months
Muscular endurance tests
Time Frame: 3-4 months
Unilateral isotonic shoulder flexion (maximum number of repetitions) and a unilateral isotonic heel lift (maximum number of repetitions)
3-4 months
Self-reported physical activity and exercise
Time Frame: 3-4 months
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.
3-4 months
Self-reported physical capacity
Time Frame: 3-4 months
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
3-4 months
Kinesiophobia (fear of movement)
Time Frame: 3-4 months
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).
3-4 months
Self-efficacy for Exercise Scale
Time Frame: 3-4 months
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
3-4 months
Self-reported perceptions on exercise
Time Frame: 3-4 months
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.
3-4 months
Cost-effectiveness
Time Frame: End of study
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.
End of study
Socio-economic evaluation
Time Frame: 6 years
Data from Statistics Sweden will be used to evaluate study results in relation to socio-economic data
6 years
Self-reported physical activity and exercise Haskell
Time Frame: 3-4 months
Haskell´s questionnaire (Min:0, Max:7). A high score means higher level of physical activity and exercise.
3-4 months
Health-related quality of life EQ5D
Time Frame: 3-4 months
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.
3-4 months
Health-related quality of life VAS
Time Frame: 3-4 months
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)
3-4 months
Number of Cardiovascular events
Time Frame: 1 and 3 years after the last patient visit
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.
1 and 3 years after the last patient visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahlgrenska University Hospital, Sweden

Collaborators

Uppsala University
Göteborg University
Linkoeping University

Investigators

  • Principal Investigator: Maria Back, Ass Prof, Sahlgrenska University Hospital, Sweden
  • Study Chair: Stefan James, Prof, Uppsala Clinial Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2020

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

February 4, 2020

First Submitted That Met QC Criteria

February 5, 2020

First Posted (Actual)

February 7, 2020

Study Record Updates

Last Update Posted (Actual)

December 5, 2024

Last Update Submitted That Met QC Criteria

December 2, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U-2018-312

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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