Prehabilitation for Patients Undergoing Transcatheter Aortic Valve Replacement

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

Official Title
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Prehabilitation for Patients Undergoing Transcatheter Aortic Valve Replacement

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Other: Pre-habilitation


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Comparing individuals who have prehabilitation prior to their TAVR procedure with those that do not.
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAVR, elevated frailty score, Transcatheter Valve Replacement