Implementation of Telerehabilitation In Support of HOme-based Physical Exercise for Heart Failure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Helse Nord-Trøndelag HF
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- Improvement in long-term physical activity.
Study Overview
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).
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Telerehabilitation (Behavioral)
Standard care
In addition to optimal medical treatment: Advice on physical activity. Electronic devices to trace activity.
Outcomes
Primary Outcomes
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
- Effects on renal function.(2 years.)
- Effects on endothelial function.(2 years.)
- Changes in cardiac structure and function.(2 years.)
- Change in physical fitness.(2 years)
- Change in long-term quality of life.(2 years.)
- Mid-term mortality(2 years)
- Long-term effects on cardiovascular risk factors.(2 years.)
- Mid-term morbidity(2 years)