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Heart Failure, SystolicITISHOPE4HFNCT03183323

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

A study testing Telerehabilitation in people with Heart Failure, Systolic and Heart Failure, Diastolic, run by Helse Nord-Trøndelag HF at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Telerehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
1 siteNorway
Study dates
8 Jun 2017to 28 Feb 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Norway1 site

  • St. Olav University Hospital

    Trondheim, 7491

Other trials in Norway

About this study

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).

Read the 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.

Being tested
Telerehabilitation
Keywords
hfpef, hfref, cardiorenal syndrome, exercise, telerehabilitation, rehabilitation
Medical subject headings
Heart Failure, Systolic, Heart Failure, Diastolic, Renal Insufficiency, Chronic, Cardio-Renal Syndrome, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TelerehabilitationBehavioural

    Also called Mio Slice, Actigraph

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

Study groups in NCT03183323
Study groupRoleWhat they receive
TelerehabilitationExperimentalIn 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.
Receives: Behavioral: Telerehabilitation
Standard careNo interventionIn addition to optimal medical treatment: Advice on physical activity. Electronic devices to trace activity.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 years

Secondary outcomes (8)

  1. Changes in cardiac structure and function.

    Echocardiographic indices - improvements from exercise.

    Measured: 2 years.

  2. Change in physical fitness.

    The change in physical fitness at from baseline to 2 years follow-up.

    Measured: 2 years

  3. Effects on renal function.

    Changes in renal function (GFR/proteinuria) by exercise.

    Measured: 2 years.

  4. Long-term effects on cardiovascular risk factors.

    Blood measurements of Cardiac risk factors.

    Measured: 2 years.

  5. Effects on endothelial function.

    Changes in peripheral arteries measured by vascular ultrasound from baseline to two years follow-up..

    Measured: 2 years.

  6. Change in long-term quality of life.

    Measured via validated questionnaires at different point during follow-up.

    Measured: 2 years.

  7. Mid-term morbidity

    Evaluate morbidity as hospitalization of cardiovascular causes

    Measured: 2 years

  8. Mid-term mortality

    Mortality during follow-up

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2017
  2. Study start8 Jun 2017
  3. Primary completion28 Feb 2021
  4. Study completion28 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
RCT, 1:1 into telerehabilitation or standard care. Patients will be stratified by EF \>/\< 40 %, age \>/\< 60 years and by sex.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03183323
Sponsor's protocol ID
LH2017_HOPE4HF
Acronym
ITISHOPE4HF
Status last verified
Apr 2022
First submitted
30 May 2017
Last updated
14 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Will follow the regulations and policy decided by the Norwegian University of Science and Technology

Publications

  • Lundgren KM, Langlo KAR, Salvesen O, Aspvik NP, Mo R, Ellingsen O, Vesterbekkmo E, Zanaboni P, Dalen H, Aksetoy IA. Exercise-Based Telerehabilitation for Heart Failure Patients Declining Outpatient Rehabilitation-A Randomized Controlled Trial. Med Sci Sports Exerc. 2025 Mar 1;57(3):449-460. doi: 10.1249/MSS.0000000000003590. Epub 2024 Nov 6.

    PubMed 39501477

  • Lundgren KM, Langlo KAR, Salvesen O, Zanaboni P, Cittanti E, Mo R, Ellingsen O, Dalen H, Aksetoy IA. Feasibility of telerehabilitation for heart failure patients inaccessible for outpatient rehabilitation. ESC Heart Fail. 2023 Aug;10(4):2406-2417. doi: 10.1002/ehf2.14405. Epub 2023 May 23.

    PubMed 37221704

Questions about this trial

What is this clinical trial studying?

A study testing Telerehabilitation in people with Heart Failure, Systolic and Heart Failure, Diastolic, run by Helse Nord-Trøndelag HF at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in long-term physical activity. (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03183323, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.

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