Transcatheter Aortic Valve Replacement (TAVR)
Conditions
Brief summary
The primary purpose of this this randomized interventional study is to determine if increased level of home-based rehabilitation coupled with a pre-TAVR consultation visit in transcatheter aortic valve replacement patients will improve functional status and quality of life and will decrease hospital readmission.
Interventions
PROCEDUREPrehabilitation visit/increased physical therapy post-TAVR
Prior to TAVR, patients randomized to the intervention arm will meet with a licensed physical therapist for a 30-minute session in the ambulatory setting. Following TAVR, patients randomized to the intervention arm will receive 4 days per week of home-based physical therapy by a licensed physical therapist working for Revival Home Health Care
PROCEDUREStandard of Care Arm
Patients randomized to the usual care arm will receive home-based physical therapy for 2 days per week by Revival Home Health Care, which is the current standard of care.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of severe aortic stenosis (AS) as determined by echocardiography, who are deemed eligible for TAVR by the NYULMC Heart Valve Team
Exclusion criteria
* Decisional impairment as assessed by the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) * Non-English/non-Spanish speaking.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in level of Activity measured by activity monitor called the ActiGraph wGT3X-BT. | Baseline, 2 Weeks |
| Change in self-perceived physical health | Baseline, 2 Weeks |
| Change in Independence in activities of daily living (ADLs). | Baseline, 2 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in hospital readmissions following intensive home-based physical therapy reduces | Baseline, 2 Weeks |
Outcome results
None listed