Prehabilitation for Patients Undergoing Transcatheter Aortic Valve Replacement
- Conditions
- Aortic Valve Stenosis
- Interventions
- Other: Pre-habilitation
- Registration Number
- NCT03107897
- Lead Sponsor
- WellSpan Health
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prehab prior to TAVR procedure. Pre-habilitation Individuals participate in prehabilitation prior to TAVR.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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?
Total hospital length of stay TAVR procedure admission Days total spent in the hospital for TAVR procedure admission
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
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?
Trial Locations
- Locations (1)
Wellspan York Hospital
🇺🇸York, Pennsylvania, United States