Prehabilitation for Patients Undergoing Transcatheter Aortic Valve Replacement

WellSpan Health35 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Aortic Valve Stenosis

Interventions

Pre-habilitationOTHER

Eight - Twelve visits to physical therapy prior to their TAVR procedure.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Wellspan York Hospital

York, Pennsylvania, United States

Outcomes

Primary Outcomes

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?

Time frame: One month post procedure

Secondary Outcomes

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?

Time frame: 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?

Time frame: 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)?

Time frame: 24-48 hours post procedure

Length of stay in the ICU

Hours total spent in the ICU for TAVR procedure admission

Time frame: TAVR procedure admission

Total hospital length of stay

Days total spent in the hospital for TAVR procedure admission

Time frame: TAVR procedure admission

Change in Quality of Life (KCCQ)

Data from ClinicalTrials.gov

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