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Clinical Trials/NCT02723422
NCT02723422
Withdrawn
Not Applicable

Intensive Versus Usual Home-based Physical Therapy to Promote Functional Recovery After Transcatheter Aortic Valve Replacement (TAVR): A Pilot Randomized Trial

NYU Langone Health0 sitesJanuary 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Transcatheter Aortic Valve Replacement (TAVR)
Sponsor
NYU Langone Health
Primary Endpoint
Change in level of Activity measured by activity monitor called the ActiGraph wGT3X-BT.
Status
Withdrawn
Last Updated
9 years ago

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.

Registry
clinicaltrials.gov
Start Date
January 2017
End Date
January 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

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)

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