Remote Exercise SWEDEHEART Study

Study Overview
=================
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). 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.

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

Conditions
-----------------
Myocardial Infarction

Intervention / Treatment
-----------------
* Other: Exercise-based cardiac rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention center<br>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<br>* 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.<br>|
| No Intervention: Control<br>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 | 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 | 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 | 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 | 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 activity and exercise Haskell | Haskell´s questionnaire (Min:0, Max:7). A high score means higher level of physical activity and exercise. | 3-4 months | 
| 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 | 3-4 months | 
| 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. | 3-4 months | 
| 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) | 3-4 months | 
| 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). | 3-4 months | 
| 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 | 3-4 months | 
| 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. | 3-4 months | 
| 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. | End of study | 
| Socio-economic evaluation | Data from Statistics Sweden will be used to evaluate study results in relation to socio-economic data | 6 years | 
| 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. | 1 and 3 years after the last patient visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EHealth, Exercise-based cardiac rehabilitation, Secondary prevention, Telerehabilitation, Physical fitness, Health-related quality of life, cost-effectiveness