Clinical trial NCT03107897: Prehabilitation for Patients Undergoing Transcatheter Aortic Valve Replacement
Official title: Prehabilitation for Patients Undergoing Transcatheter Aortic Valve Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Keywords: TAVR
elevated frailty score
Transcatheter Valve Replacement
Lead sponsor: WellSpan Health
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparing individuals who have prehabilitation prior to their TAVR procedure with those that do not.
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Functional exercise capacity - Change in 6 Minute Walk Test (6MWT)
timeFrame: One month post procedure
Secondary outcomes:
measure: Mobility - Timed Up and Go Test (TUG)
timeFrame: One month
measure: Balance - Four Square Step Test (FSST)
timeFrame: One month
measure: Discharge Disposition
timeFrame: 24-48 hours post procedure
measure: Length of stay in the ICU
timeFrame: TAVR procedure admission
measure: Total hospital length of stay
timeFrame: TAVR procedure admission
measure: Change in Quality of Life (KCCQ)
timeFrame: One month
measure: 30 day readmission
timeFrame: 30 days post procedure
Other outcomes:
Locations:
city: York
country: United States
facility: Wellspan York Hospital
state: Pennsylvania
Study officials:
affiliation: Wellspan York Hospital
name: James Harvey, MD
role: PRINCIPAL_INVESTIGATOR
References: