Implementation of Telerehabilitation In Support of HOme-based Physical Exercise for Heart Failure (ITISHOPE4HF)

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).

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Diseases; Heart Failure, Diastolic; Heart Failure, Systolic; Cardiorenal Syndrome
• Intervention / Treatment: Behavioral: Telerehabilitation

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway, 7491
    • St. Olav University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Telerehabilitation; 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; Activity trackers. Mio Slice is worn through the whole study. Actigraph is worn for one week, at 4 different timepoints through the study.; Other Names: Actigraph; Mio Slice
NO_INTERVENTION: Standard care; In addition to optimal medical treatment: Advice on physical activity. Electronic devices to trace activity.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in heart failure presentation associated with co-morbid chronic kidney disease.	Evaluated by cardiac imaging.	Baseline.
The association of cardiac fibrosis with cardiorenal syndrome	Evaluated by echo cardiography and/or cardiac MRI including T1 mapping.	Baseline
Feasibility of telerehabilitation	Assessment of the proportion of completed telerehabilitation programs	6 months.
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
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.
Long-term changes in urine metabolomics after intervention.	Looking for changes in metabolomics expression caused by exercise.	2 years.
Cost-effectiveness of telerehabilitation	Vs. outpatient rehabilitation	1 years.
Change in physical fitness	Evaluate short-term effect of telerehabilitation on measurements of physical fitness	6 months
The influence of cardiorenal characteristics on training effect	Evaluate if cardiorenal characteristics influence on change in peak oxygen consumption of training	6 months
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
Change in short-term quality of life.	Patient reported outcomes after training intervention	6 months

Collaborators and Investigators

• Sponsor: Helse Nord-Trøndelag HF
• Collaborators: Norwegian University of Science and Technology; St. Olavs Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 8, 2017
• Primary Completion (ACTUAL): February 28, 2021
• Study Completion (ACTUAL): February 28, 2021

Study Registration Dates

• First Submitted: May 30, 2017
• First Submitted That Met QC Criteria: June 8, 2017
• First Posted (ACTUAL): June 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 14, 2022
• Last Update Submitted That Met QC Criteria: April 7, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: exercise; rehabilitation; cardiorenal syndrome; telerehabilitation; hfpef; hfref
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Urologic Diseases; Renal Insufficiency; Heart Failure; Kidney Diseases; Renal Insufficiency, Chronic; Heart Failure, Diastolic; Heart Failure, Systolic; Cardio-Renal Syndrome
• Other Study ID Numbers: LH2017_HOPE4HF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Will follow the regulations and policy decided by the Norwegian University of Science and Technology

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No