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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
61
Activity trackers. Mio Slice is worn through the whole study. Actigraph is worn for one week, at 4 different timepoints through the study.
St. Olav University Hospital
Trondheim, Norway
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.
Time frame: 2 years
Changes in cardiac structure and function.
Echocardiographic indices - improvements from exercise.
Time frame: 2 years.
Change in physical fitness.
The change in physical fitness at from baseline to 2 years follow-up.
Time frame: 2 years
Effects on renal function.
Changes in renal function (GFR/proteinuria) by exercise.
Time frame: 2 years.
Long-term effects on cardiovascular risk factors.
Blood measurements of Cardiac risk factors.
Time frame: 2 years.
Effects on endothelial function.
Changes in peripheral arteries measured by vascular ultrasound from baseline to two years follow-up..
Time frame: 2 years.
Change in long-term quality of life.
Measured via validated questionnaires at different point during follow-up.
Time frame: 2 years.
Mid-term morbidity
Evaluate morbidity as hospitalization of cardiovascular causes
Time frame: 2 years
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Mid-term mortality
Mortality during follow-up
Time frame: 2 years