Brief Title
Prehabilitation for Patients Undergoing Transcatheter Aortic Valve Replacement
Official Title
Prehabilitation for Patients Undergoing Transcatheter Aortic 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.
Study Type
Interventional
Primary Outcome
Functional exercise capacity - Change in 6 Minute Walk Test (6MWT)
Secondary Outcome
Mobility - Timed Up and Go Test (TUG)
Condition
Aortic Valve Stenosis
Intervention
Pre-habilitation
Study Arms / Comparison Groups
Pre-procedure standard of care
Description: No prehab prior to TAVR.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
70
Start Date
August 17, 2016
Completion Date
May 30, 2023
Primary Completion Date
March 30, 2023
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.
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
James Harvey, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03107897
Organization ID
TAVR Prehab
Responsible Party
Principal Investigator
Study Sponsor
WellSpan Health
Study Sponsor
James Harvey, MD, Principal Investigator, Wellspan York Hospital
Verification Date
October 2021