App-Based rehab could help heart failure patients get active at home
NCT ID NCT06479876
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a home-based cardiac rehabilitation program delivered through a custom mobile app for people with heart failure. Participants use the app for education, mindfulness, and physical activity guidance, plus periodic video calls with an exercise physiologist. The goal is to see if this approach improves daily activity, quality of life, and reduces hospital visits compared to standard care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- home-based cardiac rehabilitation via a custom mobile app with video coaching
- What this could lead to
- If it works, this could offer a convenient, app-based rehab option for heart failure patients who cannot attend center-based programs.
- What could go wrong
- This is a small pilot study with only 100 participants, so results may not apply to everyone. The app-based approach may not work for those without smartphones or digital literacy.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Aug 2024
- Expected to finish
-
Aug 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria Roll-in Phase 1. Stage C HF (NYHA Class I-III) AND 1. Discharged from a HF hospitalization OR 2. Scheduled for appointment in a cardiology clinic with a prior HF hospitalization within the past 12 months OR 3. Scheduled for appointment in a cardiology clinic with a KCCQ-SS \<75 2. Receives longitudinal HF care at VUMC, including at least one visit prior to the roll-in phase Randomized Controlled Trial (beyond roll-in phase) 1\. Willingness to continue and participate in the study visits and other study activities required for the RCT Exclusion Criteria Roll-in Phase 1. Unwilling or unable to provide informed consent for participation in the RCT 2. Requires a wheelchair all (or most) of the time inside and outside the house; it is acceptable if a wheelchair is needed, for example, for parking lot transfer for a clinic visit and navigating around the hospital without it being needed in the home 3. If an individual uses a walker or cane all (or most) of the time, then he/she will be excluded if he/she scores 2 or lower on the Mini-Cog or the patient is unable to perform 2 chair sit-to-stands independently or is deemed to be at high fall risk during baseline visit assessment. 4. History of falls over the last 6 months; an isolated explainable fall with no injury would not exclude the patient, but a tendency to falls indicative of balance/stability issues would exclude the patient. 5. Age \< 18 years 6. Stage D HF (advanced HF under evaluation for LVAD or transplant) 7. NYHA class IV symptoms 8. Congenital heart disease 9. Pregnant 10. Group 1 pulmonary hypertension 11. Moderate-severe or severe (\> 3+) mitral or aortic valvular disease 12. Physical or neuropsychiatric limitations that would prevent proficient use of the study tools and successful completion of the physical and quality of life assessments (e.g. blindness, dementia) 13. Planned surgery within 3 months 14. Planned discharge from hospital to hospice, assisted living, or inpatient rehabilitation facility (discharge to a senior facility permitted as long as they are considered Independent Living) 15. Treating provider or study team physician indicates that participation in the RCT would be unsafe 16. Participation in any ongoing randomized trial that has not completed follow-up Randomized Controlled Trial (beyond roll-in phase) 1. Not adherent to wearing the Actigraph activity tracker during the roll-in phase for a minimum of 4 (out of 10) compliant days (worn ³10 hours/day). Allowance will be made to include participants who wear the ActiGraph device ³10 hours/day for 3 days and also wear the ActiGraph device \>9 hours/day for at least 1 day. 2. Unable to complete the baseline study visit within 4 weeks of the completion of the roll-in actigraphy assessment.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Cardiovascular diseases are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Vanderbilt University Medical Center
RECRUITINGNashville, Tennessee, 37232, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a nurse and a neighbor help tame chronic disease?
- Could a handheld ultrasound help clinics spot heart failure sooner?
- Two eggs a day put to the test for heart health
- A soft patch that watches your heart beat in real time
- Can a Once-Daily form of tacrolimus spare liver transplant patients from side effects?
- Can yoga classes rival standard rehab for a failing heart?