Aortic Valve Stenosis
Conditions
Keywords
TAVR, elevated frailty score, Transcatheter Valve Replacement
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.
Interventions
OTHERPre-habilitation
Eight - Twelve visits to physical therapy prior to their TAVR procedure.
Sponsors
WellSpan Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Comparing individuals who have prehabilitation prior to their TAVR procedure with those that do not.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional exercise capacity - Change in 6 Minute Walk Test (6MWT) | One month post procedure | 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? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Balance - Four Square Step Test (FSST) | One month | 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? |
| Discharge Disposition | 24-48 hours post procedure | 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)? |
| Length of stay in the ICU | TAVR procedure admission | Hours total spent in the ICU for TAVR procedure admission |
| Mobility - Timed Up and Go Test (TUG) | One month | 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? |
| Change in Quality of Life (KCCQ) | One month | Does the Kansas City Cardiomyopathy Questionnaire score change from the first physical therapy assessment to one month post-procedure? |
| 30 day readmission | 30 days post procedure | Does the subject have a 30 day re-admission post-procedure? |
| Total hospital length of stay | TAVR procedure admission | Days total spent in the hospital for TAVR procedure admission |
Countries
United States
Outcome results
None listed