NCT06479876 - Home-Based Cardiac Rehabilitation for Patients With Heart Failure | Crick

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Average daily total activity counts

Daily total activity counts are determined by a triaxial actigraphy device.

Time frame: The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily total activity counts determined. The primary comparison will be at 12 weeks after randomization.

Secondary Outcomes

Average daily active minutes

Daily active minutes are determined by a triaxial actigraphy device.

Time frame: The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily activity minutes determined. The comparison will be at 12 weeks after randomization.

Average daily steps

Daily steps are determined by a triaxial actigraphy device.

Time frame: The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily steps determined. The comparison will be at 12 weeks after randomization.

Average daily energy expenditure

Average daily energy expenditure is determined by a triaxial actigraphy device.

Time frame: The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily energy expenditure determined. The comparison will be at 12-weeks after randomization.

Average daily moderate to vigorous active minutes

Daily moderate to vigorous active minutes are determined by a triaxial actigraphy device.

Time frame: The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily moderate to vigorous active mins determined. The comparison will be at 12-weeks after randomization.

Sustained physical activity bursts of 10 minutes or greater per day

Physical activity bursts are determined by a triaxial actigraphy device.

6 minute walk distance

The distance walked in 6 minutes.