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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-08

Study Completion Date

2021-02-28

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Heart Failure, Systolic Heart Failure, Diastolic Chronic Kidney Diseases Cardiorenal Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

RCT, 1:1 into telerehabilitation or standard care. Patients will be stratified by EF \>/\< 40 %, age \>/\< 60 years and by sex.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Group assignment is not masked at performance tests. Group assignment is masked to the echo/MRI technician, and for investigators interpreting the recordings.

Masking is not relevant for laboratory analysis.

Study Groups

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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.

Group Type EXPERIMENTAL

Telerehabilitation

Intervention Type BEHAVIORAL

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

Standard care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Telerehabilitation

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Mio Slice Actigraph

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No