Prehabilitation for Patients Undergoing Transcatheter Aortic Valve Replacement (TAVR-Prehab)

In this pilot study, investigators aim to identify patients undergoing TAVR who are at elevated risk for adverse clinical events due to decreased exertional capacity and physical deconditioning. Investigators aim to determine if monitored pre-procedural physical therapy is safe in these patients. Lastly, investigators aim to assess the efficacy of prehabilitation

1. to improve physical functioning by the time of TAVR and to sustain benefit through 30 days post-procedure; and
2. to determine its effect on post-procedural length-of-stay, clinical outcomes, and quality of life.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Other: Pre-habilitation

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • York, Pennsylvania, United States, 17403
      • WellSpan York Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subject must be ambulatory (with or without an assist device)
• Subject has severe aortic stenosis and is felt an appropriate candidate for TAVR by the Heart Team.
• Subject requires 6.0 seconds or longer to complete a 15ft walk test
• Subject must be able to move between sitting and standing without assistance from another person.
• Subject has adequate iliac and femoral arterial anatomy to allow for TAVR via transfemoral access
• Subject is 18 years of age or greater
• Subject is willing to give consent and participate in the study

Exclusion Criteria:

• Subject is incapable of following instructions
• Subject is unable to meet the minimum required physical therapy visits
• Subject has other medical conditions rendering it unsafe, in the opinion of the Principal Investigator and physical therapy staff, to perform a 6 Minute Walk Test or physical therapy conditioning prior to TAVR
• Subject has significant severe un-revascularized epicardial coronary disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Pre-procedure standard of care; No prehab prior to TAVR.
Active Comparator: Prehab prior to TAVR procedure.; Individuals participate in prehabilitation prior to TAVR.	Other: Pre-habilitation; Eight - Twelve visits to physical therapy prior to their TAVR procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional exercise capacity - Change in 6 Minute Walk Test (6MWT)	Measure: Does prehabilitation improve the subject's functional exercise capacity from first PT assessment to pre-procedure assessment and first PT assessment to one month post-procedure, as measured by the 6MWT?	One month post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mobility - Timed Up and Go Test (TUG)	Does prehabilitation improve the subject's mobility from first physical therapy assessment to pre-procedure assessment and first PT assessment to one month post-procedure, as measured by the TUG test?	One month
Balance - Four Square Step Test (FSST)	Does prehabilitation improve the subject's balance from first physical therapy assessment to preprocedure assessment and first PT assessment to one month post-procedure, as measured by the FSST?	One month
Discharge Disposition	Does prehabilitation make it less likely that a patient will require a higher level of care at discharge than they require prior to admission (for example, arrive from home and discharged to home)?	24-48 hours post procedure
Length of stay in the ICU	Hours total spent in the ICU for TAVR procedure admission	TAVR procedure admission
Total hospital length of stay	Days total spent in the hospital for TAVR procedure admission	TAVR procedure admission
Change in Quality of Life (KCCQ)	Does the Kansas City Cardiomyopathy Questionnaire score change from the first physical therapy assessment to one month post-procedure?	One month
30 day readmission	Does the subject have a 30 day re-admission post-procedure?	30 days post procedure

Collaborators and Investigators

• Sponsor: WellSpan Health
• Investigators: Principal Investigator: James Harvey, MD, WellSpan York Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2016
• Primary Completion (Actual): August 9, 2020
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: March 7, 2017
• First Submitted That Met QC Criteria: April 10, 2017
• First Posted (Actual): April 11, 2017

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: June 7, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: TAVR; Transcatheter Valve Replacement; elevated frailty score
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: TAVR Prehab

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All individual participant data defined in the protocol will be collected during trial participation and entered in a secured Electronic Data Capturing System. All data shared or copied shared will only occur after complete deidentification. Participant data will be made available for Annual Data Safety Management Board (DSMB) committee review. The Study Protocol, Informed Consent Form, and applicable Case Report Forms will be available.
• IPD Sharing Time Frame: Immediately following publication. No End Date
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No