Remote Exercise SWEDEHEART Study
- Conditions
- Myocardial Infarction
- Interventions
- Other: Exercise-based cardiac rehabilitation
- Registration Number
- NCT04260958
- Lead Sponsor
- Sahlgrenska University Hospital, Sweden
- 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).
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1500
- Written informed consent
- Diagnosis of type 1 myocardial infarction (AMI)
- Age 18-79 years at discharge from hospital
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Intervention center Exercise-based cardiac rehabilitation 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.
- Primary Outcome Measures
Name Time Method Mean number of exCR sessions 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 Outcome Measures
Name Time Method Health-related quality of life VAS 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)
Self-reported perceptions on exercise 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.
Self-reported physical activity and exercise 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.
Self-reported physical activity and exercise Haskell 3-4 months Haskell´s questionnaire (Min:0, Max:7). A high score means higher level of physical activity and exercise.
Submaximal exercise capacity 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.
Muscular endurance tests 3-4 months Unilateral isotonic shoulder flexion (maximum number of repetitions) and a unilateral isotonic heel lift (maximum number of repetitions)
Self-reported physical capacity 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
Self-efficacy for Exercise Scale 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
Kinesiophobia (fear of movement) 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).
Cost-effectiveness 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.
Number of Cardiovascular events 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.
Health-related quality of life EQ5D 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.
Socio-economic evaluation 6 years Data from Statistics Sweden will be used to evaluate study results in relation to socio-economic data
Trial Locations
- Locations (26)
Södra Älvsborg Hospital
🇸🇪Borås, Sweden
Mälarsjukhuset
🇸🇪Eskilstuna, Sweden
Falun hospital
🇸🇪Falun, Sweden
Angered Hospital
🇸🇪Gothenburg, Sweden
Sahlgrenska University Hospital Östra
🇸🇪Gothenburg, Sweden
Sahlgrenska University Hospital
🇸🇪Gothenburg, Sweden
Gällivare Hospital
🇸🇪Gällivare, Sweden
Gävle Hospital
🇸🇪Gävle, Sweden
Hässleholm Hospital
🇸🇪Hässleholm, Sweden
Jönköping Ryhov hospital
🇸🇪Jönköping, Sweden
Kalix hospital
🇸🇪Kalix, Sweden
Kalmar Hospital
🇸🇪Kalmar, Sweden
Kungälv Hospital
🇸🇪Kungälv, Sweden
Lindesberg Hospital
🇸🇪Lindesberg, Sweden
Linköping University Hospital
🇸🇪Linköping, Sweden
Ljungby Hospital
🇸🇪Ljungby, Sweden
Sunderbyn hospital
🇸🇪Luleå, Sweden
Skåne University hospital
🇸🇪Lund, Sweden
Skåne University Hospital Malmö
🇸🇪Malmö, Sweden
Capio St Göran Hospital
🇸🇪Stockholm, Sweden
Karolinska University Hospital
🇸🇪Stockholm, Sweden
Sundsvall hospital
🇸🇪Sundsvall, Sweden
Södertälje Hospital
🇸🇪Södertälje, Sweden
Uppsala University Hopsital
🇸🇪Uppsala, Sweden
Värnamo hospital
🇸🇪Värnamo, Sweden
Östersund hospital
🇸🇪Östersund, Sweden