Intensive Versus Usual Home-based Physical Therapy to Promote Functional Recovery After Transcatheter Aortic Valve Replacement (TAVR): A Pilot Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- NYU Langone Health
- Primary Endpoint
- Change in level of Activity measured by activity monitor called the ActiGraph wGT3X-BT.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 75 Years to — (Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Prehabilitation Visit/Increased Physical Therapy post-TAVR
Intervention: Prehabilitation visit/increased physical therapy post-TAVR (Procedure)
Control
Standard of care physical therapy post-TAVR
Intervention: Standard of Care Arm (Procedure)
Outcomes
Primary Outcomes
Change in level of Activity measured by activity monitor called the ActiGraph wGT3X-BT.
Time Frame: Baseline, 2 Weeks
Change in self-perceived physical health
Time Frame: Baseline, 2 Weeks
Change in Independence in activities of daily living (ADLs).
Time Frame: Baseline, 2 Weeks
Secondary Outcomes
- Reduction in hospital readmissions following intensive home-based physical therapy reduces(Baseline, 2 Weeks)