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

April 7, 2022 updated by: Helse Nord-Trøndelag HF
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
61

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Improvement in long-term physical activity.
Time Frame: 2 years
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in cardiac structure and function.
Time Frame: 2 years.
Echocardiographic indices - improvements from exercise.
2 years.
Change in physical fitness.
Time Frame: 2 years
The change in physical fitness at from baseline to 2 years follow-up.
2 years
Effects on renal function.
Time Frame: 2 years.
Changes in renal function (GFR/proteinuria) by exercise.
2 years.
Long-term effects on cardiovascular risk factors.
Time Frame: 2 years.
Blood measurements of Cardiac risk factors.
2 years.
Effects on endothelial function.
Time Frame: 2 years.
Changes in peripheral arteries measured by vascular ultrasound from baseline to two years follow-up..
2 years.
Change in long-term quality of life.
Time Frame: 2 years.
Measured via validated questionnaires at different point during follow-up.
2 years.
Mid-term morbidity
Time Frame: 2 years
Evaluate morbidity as hospitalization of cardiovascular causes
2 years
Mid-term mortality
Time Frame: 2 years
Mortality during follow-up
2 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Differences in heart failure presentation associated with co-morbid chronic kidney disease.
Time Frame: Baseline.
Evaluated by cardiac imaging.
Baseline.
The association of cardiac fibrosis with cardiorenal syndrome
Time Frame: Baseline
Evaluated by echo cardiography and/or cardiac MRI including T1 mapping.
Baseline
Feasibility of telerehabilitation
Time Frame: 6 months.
Assessment of the proportion of completed telerehabilitation programs
6 months.
Validation of the Mio Slice as a scientific activity tracker.
Time Frame: 6 months
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.
Time Frame: Baseline.
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.
Time Frame: 2 years.
Looking for changes in metabolomics expression caused by exercise.
2 years.
Cost-effectiveness of telerehabilitation
Time Frame: 1 years.
Vs. outpatient rehabilitation
1 years.
Change in physical fitness
Time Frame: 6 months
Evaluate short-term effect of telerehabilitation on measurements of physical fitness
6 months
The influence of cardiorenal characteristics on training effect
Time Frame: 6 months
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
Time Frame: 12 months
Evaluate if renal function modulate the training effect on changes in cardiac characteristics
12 months
Change in short-term quality of life.
Time Frame: 6 months
Patient reported outcomes after training intervention
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Helse Nord-Trøndelag HF

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Norwegian University of Science and Technology
St. Olavs Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 8, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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