Implementation of Telerehabilitation In Support of HOme-based Physical Exercise for Heart Failure

Study Overview
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Brief Summary
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ITISHOPE4HF is a randomized controlled trial of telerehabilitation in a heart failure population. The goal is to evaluate if a home-based telerehabilitation project can increase physical activity in heart failure patients. Patients will be provided telerehabilitation or advice on physical activity (standard care).

Detailed Description
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Outpatient cardiac rehabilitation programs are well documented as an important part of treatment and care for heart failure patients. Training with instruction gives the participant a commitment to participate. The result is increased activity compared to controls. This trial will include participants from the about 75 % of heart failure patients who for some reason do not participate in regular outpatient rehabilitation. Distance to rehabilitation centers and the psychological burden of a group setting are believed to be important reasons for not participating. Telerehabilitation can hopefully overcome these hurdles for many patients, and thereby provide instructed training for these patients. The trial will also include patients with renal disease. Heart disease is the main cause of death in patients with renal disease, even at younger ages. Because of the complexity of both optimal medical treatment and fluid balance, these patients are often not included in clinical trials. The cardiorenal crosstalk will be explored, how in influence the heart failure phenotypes and the response to exercise.

Official Title
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Implementation of Telerehabilitation In Support of HOme-based Physical Exercise for Heart Failure

Conditions
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Heart Failure, Systolic, Heart Failure, Diastolic, Chronic Kidney Diseases, Cardiorenal Syndrome

Intervention / Treatment
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* Behavioral: Telerehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Heart failure (HFpEF or HFrEF) according to European guidelines. Moderate or severe signs and symptoms of heart failure (NYHA II-III) in the 6 months prior to enrolment. N-terminal pro brain natriuretic peptide (NT-proBNP) > 300 pmol/L. Stable (> 4 weeks) medical therapy for risk factor control. Capability to provide signed, informed, written consent. Exclusion Criteria: Attendance at a rehabilitation program in the 6 months prior to enrolment. Non-heart failure causes of heart failure symptoms (significant valvular disease, coronary disease available for revascularization, uncontrolled hypertension, arrhythmia). severe or very severe pulmonary disease (eg. COPD GOLD III-IV). presence of conditions which might prevent patients from safely exercising at home.

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
Interventional Model Description: RCT, 1:1 into telerehabilitation or standard care. Patients will be stratified by EF >/< 40 %, age >/< 60 years and by sex.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telerehabilitation<br>In addition to optimal medical treatment: 3 months of twice weekly group-based telerehabilitation through a video-conferencing on a tablet platform. In addition access to instruction videos for further self-training through the same platform and throughout the whole 2-year period. Electronic devices to trace activity. | Behavioral: Telerehabilitation<br>* Activity trackers. Mio Slice is worn through the whole study. Actigraph is worn for one week, at 4 different timepoints through the study.<br>* Other names: Actigraph;|
| No Intervention: Standard care<br>In addition to optimal medical treatment: Advice on physical activity. Electronic devices to trace activity. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in long-term physical activity. | Change in physical activity between intervention and control group measured throughout the study with Actigraph activity trackers from baseline to 2 years. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in cardiac structure and function. | Echocardiographic indices - improvements from exercise. | 2 years. | 
| Change in physical fitness. | The change in physical fitness at from baseline to 2 years follow-up. | 2 years | 
| Effects on renal function. | Changes in renal function (GFR/proteinuria) by exercise. | 2 years. | 
| Long-term effects on cardiovascular risk factors. | Blood measurements of Cardiac risk factors. | 2 years. | 
| Effects on endothelial function. | Changes in peripheral arteries measured by vascular ultrasound from baseline to two years follow-up.. | 2 years. | 
| Change in long-term quality of life. | Measured via validated questionnaires at different point during follow-up. | 2 years. | 
| Mid-term morbidity | Evaluate morbidity as hospitalization of cardiovascular causes | 2 years | 
| Mid-term mortality | Mortality during follow-up | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hfpef, hfref, cardiorenal syndrome, exercise, telerehabilitation, rehabilitation