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

NCT03183323 | Completed DMC

• 1 other identifier: LH2017_HOPE4HF
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

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

Keywords

hfpef; hfref; cardiorenal syndrome; exercise; telerehabilitation; rehabilitation

Outcome Measures

Primary Outcomes (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.

  2 years

Secondary Outcomes (8)

• Changes in cardiac structure and function.

  2 years.

• Change in physical fitness.

  2 years

• Effects on renal function.

  2 years.

• Long-term effects on cardiovascular risk factors.

  2 years.

• Effects on endothelial function.

  2 years.

Other Outcomes (11)

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

  Baseline.

• The association of cardiac fibrosis with cardiorenal syndrome

  Baseline

• Feasibility of telerehabilitation

  6 months.

Study Arms (2)

Telerehabilitation

EXPERIMENTAL

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

Standard care

NO INTERVENTION

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

Interventions

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.

Also known as: Mio Slice, Actigraph

Telerehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helse Nord-Trøndelag HF: lead
• Norwegian University of Science and Technology: collaborator
• St. Olavs Hospital: collaborator

Study Sites (1)

St. Olav University Hospital

Trondheim, 7491, Norway

Location

Related Publications (2)

• 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.

  PMID: 39501477 DERIVED

• 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.

  PMID: 37221704 DERIVED

MeSH Terms

Conditions

Heart Failure, Systolic; Heart Failure, Diastolic; Renal Insufficiency, Chronic; Cardio-Renal Syndrome; Motor Activity

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Havard Dalen, MD, PhD

  Norwegian University of Science and Tehnology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: June 12, 2017
• Study Start: June 8, 2017
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: April 14, 2022

Record last verified: 2022-04

Locations

NO (1)