Prehabilitation for Patients Undergoing Transcatheter Aortic Valve Replacement
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 5/24/2018 |
| Start Date: | August 17, 2016 |
| End Date: | May 30, 2020 |
| Contact: | Barbara A Delio-Cox, MSN |
| Email: | bdeliocox@wellspan.org |
| Phone: | 717-851-3472 |
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.
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.
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.
We found this trial at
3
sites
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694 Good Drive
Lancaster, Pennsylvania 17601
Lancaster, Pennsylvania 17601
Phone: 717-544-1777
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