Transcatheter Aortic Valve Replacement (TAVR)-Pilot Trial (TAVR-PT)

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

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 Overview

• Status: Withdrawn
• Conditions: Transcatheter Aortic Valve Replacement (TAVR)
• Intervention / Treatment: Procedure: Prehabilitation visit/increased physical therapy post-TAVR; Procedure: Standard of Care Arm

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prehabilitation Visit/Increased Physical Therapy post-TAVR	Procedure: Prehabilitation 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
Active Comparator: Control; Standard of care physical therapy post-TAVR	Procedure: Standard 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.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Reduction in hospital readmissions following intensive home-based physical therapy reduces	Baseline, 2 Weeks

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: John Dodson, MD, New York University Medical School

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: March 9, 2016
• First Submitted That Met QC Criteria: March 23, 2016
• First Posted (Estimate): March 30, 2016

Study Record Updates

• Last Update Posted (Estimate): January 30, 2017
• Last Update Submitted That Met QC Criteria: January 27, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 15-01098