Status:
UNKNOWN
Physiological Reconditioning Program Administered Remotely in Patients Undergoing Transcatheter Aortic Valve Replacement: A Pilot Study
Lead Sponsor:
Unity Health Toronto
Conditions:
Frailty
Transcatheter Aortic Valve Replacement
Eligibility:
All Genders
60-95 years
Phase:
NA
Brief Summary
The PREPARE TAVR pilot study will examine the effects of remotely administered physiological reconditioning program (RAPR) on quality of life (QOL) and clinical outcomes at one year post TAVR in frail...
Detailed Description
The main objective of this study is to evaluate the effects of a home based exercise and dietary intervention program on the quality of life (QOL) and clinical outcomes in frail adults undergoing Tran...
Eligibility Criteria
Inclusion
- \- Short Physical Performance Battery Protocol (SPPB) score \< 9
Exclusion
- Severe liver disease defined by Childs Pugh class \>B or MELD score \>15.
- Severe kidney disease defined by eGFR \<30 mL/min.
- Hospital admission during the 4 weeks prior to randomization.
- Montreal objective cognitive assessment (MOCA) score \<18.
- Mechanical fall in the past month.
- Unstable angina during the previous month.
- Myocardial infarction during the previous month.
- Unsuccessful completion of the one-week run-in phase.
- Syncopal episode during exercise during run-in phase
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2022
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT03801460
Start Date
July 1 2020
End Date
March 31 2022
Last Update
January 13 2021
Active Locations (1)
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1
Southlake Hospital
Newmarket, Ontario, Canada