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

Chronic Kidney Diseases Clinical Trial

— ITISHOPE4HF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03183323
• Other study ID #: LH2017_HOPE4HF
• Status: Completed
• Phase: N/A
• Start date: June 8, 2017
• Est. completion date: February 28, 2021

Study information

• Verified date: April 2022
• Source: Helse Nord-Trøndelag HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Cardio-Renal Syndrome
• Cardiorenal Syndrome
• Chronic Kidney Diseases
• Heart Failure
• Heart Failure, Diastolic
• Heart Failure, Systolic
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• Telerehabilitation
Activity trackers. Mio Slice is worn through the whole study. Actigraph is worn for one week, at 4 different timepoints through the study.

Locations

Country	Name	City	State
Norway	St. Olav University Hospital	Trondheim

Sponsors (3)

Lead Sponsor	Collaborator
Helse Nord-Trøndelag HF	Norwegian University of Science and Technology, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

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