Remotely Monitored and Coached Cardiac Rehabilitation Northern Sweden

Study Overview
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Brief Summary
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Supervised exercise is an essential component of contemporary center-based cardiac rehabilitation (CR) programs. Despite the proven effectiveness, uptake and adherence to supervised exercise-based CR (exCR) remains suboptimal (approximately 50%), especially in rural and remote areas of Sweden. The main reasons for low participation rate in centre-based exCR are different accessibility barriers i.e. long distances, transportation problems or employment commitments. In this randomised clinical trial, the overall aim is to evaluate the effectiveness of, home-based, remotely monitored and coached exCR using the REMOTE-CR system compared to home-based exCR based on individualized information regarding current exercise recommendations but without monitoring and coaching (usual care) to improve exercise capacity. Our hypothesis is that remotely monitored and coached exCR will improve exercise capacity to a greater extent than home-based exCR without monitoring and coaching (usual care).

Official Title
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Remotely Monitored and Coached Exercise Based Cardiac Rehabilitation in Northern Sweden l

Conditions
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Heart Defects, Congenital

Intervention / Treatment
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* Behavioral: REMOTE-CR
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled appointment with physiotherapist for follow-up after cardiac event: ----Myocardial Infarction (MI) Per cutaneous coronary intervention (PCI) due to MI or angina pectoris Open heart surgery due to coronary artery disease or valvar disease Living in the catchment area of Heart centre, University Hospital of Umeå. Exclusion Criteria: Clinically unstable Postoperative infection Comorbidity affecting ability to participate in exCR

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: REMOTE-CR<br>Remotely monitored and coached exercise training in real time using the REMOTE-CR system. The patients randomized to remotely monitored exercise can either work out with self-selected activities e.g. Nordic-walking, cycling, skiing or participate in supervised exercise session via video link. | Behavioral: REMOTE-CR<br>* The patients randomized to remotely monitored exercise can either work out with self-selected activities e.g. Nordic-walking, cycling, skiing or participate in supervised exercise session via video link. Remotely monitored exercise training sessions will be offered monday-friday 13.00-16.00.<br>|
| Other: Usual care<br>The patients randomized to be controls will receive individualized information and instructions regarding current exercise recommendations but will not be monitored or coached during their exercise sessions (usual care). | Other: Control<br>* The patients randomized to be controls will receive individualized information and instructions regarding current exercise recommendations but will not be monitored or coached during their exercise sessions (usual care)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in submaximal aerobic exercise capacity | The aerobic exercise capacity (W) will be evaluated using a standardised submaximal exercise test on cycle ergometer | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle endurance capacity | Number of repetitions achieved during test of Unilateral isotonic shoulder flexion and Unilateral isotonic heel-lift | Baseline and 12 weeks | 
| Isometric grip strength | Isometric grip strength will be evaluated using a hydraulic hand dynamometer | Baseline and 12 weeks | 
| Self-reported physical activity using theInternational Physical Activity Questionnaire | International Physical Activity Questionnaire: Results will be presented as a continuous variable, total metabolic equivalent (MET) minutes per week, where a higher score indicates a higher physical activity level. Result will also be presented as a categorical variable: High Physical activity level: achieving a total physical activity of at least 3000 MET-minutes/week. Moderate physical activity: achieving a minimum of at least 600 MET-minutes per week. Low physical activity level: not achieving the minimum of 600 MET minutes per week | Baseline and 12 weeks | 
| Self-reported physical activity using the physical activity scale br Frändin and Grimby | The Activity scale by Frändin and Grimby describes 6 levels of physical activity. The scale includes 6 items that ranges from 1 indicating mostly physically inactive to 6 indicating a very high physical activity level. | Baseline and 12 weeks | 
| Kinesiophobia (fear of movement) | The Swedish version of the Tampa scale for Kinesiophobia Heart (TSK-SV Heart) The scale comprises 17 items assessing subjective rating of kinesiophobia. The total score varies between 17-68 and a score >37 defines a high level of kinesofobia. | Baseline and 12 weeks |