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

Helse Nord-Trøndelag HF

Status: Completed

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

Treatments: Behavioral: Telerehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT03183323

LH2017_HOPE4HF

Details and patient eligibility

About

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).

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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61 participants in 2 patient groups

Telerehabilitation

Experimental group

Description:

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.

Treatment:

Behavioral: Telerehabilitation

Standard care

No Intervention group

Description:

In addition to optimal medical treatment: Advice on physical activity. Electronic devices to trace activity.