Chronic Kidney Diseases Clinical Trial
— ITISHOPE4HFOfficial title:
Implementation of Telerehabilitation In Support of HOme-based Physical Exercise for Heart Failure
Verified date | April 2022 |
Source | Helse Nord-Trøndelag HF |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 61 |
Est. completion date | February 28, 2021 |
Est. primary completion date | February 28, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Norway | St. Olav University Hospital | Trondheim |
Lead Sponsor | Collaborator |
---|---|
Helse Nord-Trøndelag HF | Norwegian University of Science and Technology, St. Olavs Hospital |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Differences in heart failure presentation associated with co-morbid chronic kidney disease. | Evaluated by cardiac imaging. | Baseline. | |
Other | The association of cardiac fibrosis with cardiorenal syndrome | Evaluated by echo cardiography and/or cardiac MRI including T1 mapping. | Baseline | |
Other | Feasibility of telerehabilitation | Assessment of the proportion of completed telerehabilitation programs | 6 months. | |
Other | Validation of the Mio Slice as a scientific activity tracker. | Comparison of data from the Mio Slice with reference to validate it as a scientific tool for monitoring heart failure patients | 6 months | |
Other | Urine metabolomics Associated With heart failure phenotypes. | Comparing traits in urine metabolomics between participants with and without chronic kidney disease. Comparing with earlier studies of patients with chronic kidney disease and healthy controls. | Baseline. | |
Other | Long-term changes in urine metabolomics after intervention. | Looking for changes in metabolomics expression caused by exercise. | 2 years. | |
Other | Cost-effectiveness of telerehabilitation | Vs. outpatient rehabilitation | 1 years. | |
Other | Change in physical fitness | Evaluate short-term effect of telerehabilitation on measurements of physical fitness | 6 months | |
Other | The influence of cardiorenal characteristics on training effect | Evaluate if cardiorenal characteristics influence on change in peak oxygen consumption of training | 6 months | |
Other | Do renal function modulate the training effect on cardiac remodeling | Evaluate if renal function modulate the training effect on changes in cardiac characteristics | 12 months | |
Other | Change in short-term quality of life. | Patient reported outcomes after training intervention | 6 months | |
Primary | 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 | Changes in cardiac structure and function. | Echocardiographic indices - improvements from exercise. | 2 years. | |
Secondary | Change in physical fitness. | The change in physical fitness at from baseline to 2 years follow-up. | 2 years | |
Secondary | Effects on renal function. | Changes in renal function (GFR/proteinuria) by exercise. | 2 years. | |
Secondary | Long-term effects on cardiovascular risk factors. | Blood measurements of Cardiac risk factors. | 2 years. | |
Secondary | Effects on endothelial function. | Changes in peripheral arteries measured by vascular ultrasound from baseline to two years follow-up.. | 2 years. | |
Secondary | Change in long-term quality of life. | Measured via validated questionnaires at different point during follow-up. | 2 years. | |
Secondary | Mid-term morbidity | Evaluate morbidity as hospitalization of cardiovascular causes | 2 years | |
Secondary | Mid-term mortality | Mortality during follow-up | 2 years |
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