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Completed

NCT Number: NCT03183323

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

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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Key information

Conditions

Heart Failure, Systolic Behavior Cardio-Renal Syndrome Cardiorenal Syndrome Cardiovascular Diseases Chronic Disease Chronic Kidney Diseases Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Heart Failure Heart Failure, Diastolic Kidney Diseases Male Urogenital Diseases Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Olav University Hospital

Trondheim, 7491, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telerehabilitation

Behavioral

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: Mio Slice, Actigraph

Primary outcomes

  1. 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.

Secondary outcomes

  1. Changes in cardiac structure and function.

    Time frame: 2 years.

    Echocardiographic indices - improvements from exercise.

  2. Change in physical fitness.

    Time frame: 2 years

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

  3. Effects on renal function.

    Time frame: 2 years.

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

  4. Long-term effects on cardiovascular risk factors.

    Time frame: 2 years.

    Blood measurements of Cardiac risk factors.

  5. Effects on endothelial function.

    Time frame: 2 years.

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

  6. Change in long-term quality of life.

    Time frame: 2 years.

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

  7. Mid-term morbidity

    Time frame: 2 years

    Evaluate morbidity as hospitalization of cardiovascular causes

  8. Mid-term mortality

    Time frame: 2 years

    Mortality during follow-up

Other outcomes

  1. Differences in heart failure presentation associated with co-morbid chronic kidney disease.

    Time frame: Baseline.

    Evaluated by cardiac imaging.

  2. The association of cardiac fibrosis with cardiorenal syndrome

    Time frame: Baseline

    Evaluated by echo cardiography and/or cardiac MRI including T1 mapping.

  3. Feasibility of telerehabilitation

    Time frame: 6 months.

    Assessment of the proportion of completed telerehabilitation programs

  4. 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

  5. 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.

  6. Long-term changes in urine metabolomics after intervention.

    Time frame: 2 years.

    Looking for changes in metabolomics expression caused by exercise.

  7. Cost-effectiveness of telerehabilitation

    Time frame: 1 years.

    Vs. outpatient rehabilitation

  8. Change in physical fitness

    Time frame: 6 months

    Evaluate short-term effect of telerehabilitation on measurements of physical fitness

  9. 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

  10. 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

  11. Change in short-term quality of life.

    Time frame: 6 months

    Patient reported outcomes after training intervention

Sponsors and collaborators

Lead sponsor

Helse Nord-Trøndelag HF

Other

Collaborators

  • Norwegian University of Science and Technology
  • St. Olavs Hospital

Registry information

Acronym: ITISHOPE4HF

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jun 12, 2017
Registry last updated
Apr 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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