Brief Title
Prehabilitation to Improve Functional and Clinical Outcomes in Patients With Aortic Stenosis
Official Title
Prehabilitation to Improve Functional and Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement: TAVR-FRAILTY Trial
Brief Summary
Transcatheter aortic valve replacement (TAVR) is a treatment alternative among high-risk elderly with aortic stenosis, however, mortality remains high. Fifty percent of patients undergoing TAVR exhibit frailty, a syndrome associated with poor survival. It is unknown whether interventions to improve frailty before TAVR (prehabilitation) will improve outcomes after TAVR. This study plans to evaluate whether simple cardiac exercise interventions to improve physical performance before TAVR improves outcomes after TAVR.
Study Type
Interventional
Primary Outcome
Change in Score on short physical performance battery (SPPB) test
Condition
Aortic Stenosis
Intervention
Prehabilitation
Study Arms / Comparison Groups
Prehabilitation
Description: Will receive 4 weeks of supervised exercised prescription before they undergo TAVR and will monitor and record, improvement if any, in the short-term physical performance battery score
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
40
Start Date
October 2015
Completion Date
October 2021
Primary Completion Date
October 2021
Eligibility Criteria
Inclusion criteria: - Eligibility for TAVR - SPPB<9 - Able to exercise - Able to come for follow-up visits - Able to give informed consent Exclusion criteria: - New York Heart Association (NYHA) Class III/IV congestive heart failure (CHF) - Presyncope or syncope as presentation - Acute coronary syndrome - Unable to exercise - Dementia - Sustained ventricular arrhythmia - Stroke with neurological deficit - Advanced Parkinson's - Participated in an exercise program
Gender
All
Ages
60 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Mandeep Singh, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02597985
Organization ID
15-004180
Responsible Party
Principal Investigator
Study Sponsor
Mayo Clinic
Study Sponsor
Mandeep Singh, MD, Principal Investigator, Mayo Clinic
Verification Date
January 2020