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Active, Not Recruiting

NCT Number: NCT04260958

Remote Exercise SWEDEHEART Study

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Södra Älvsborg Hospital, Borås, Sweden

Loading trial locations.

About this study

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).

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise-based cardiac rehabilitation

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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. 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.

  4. 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.

  5. 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

  6. 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.

  7. 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)

  8. 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).

  9. 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

  10. 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.

  11. 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.

  12. Socio-economic evaluation

    Time frame: 6 years

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

  13. 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.

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2028
First posted
Feb 7, 2020
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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