Physiological Reconditioning Program Administered Remotely in Patients Undergoing Transcatheter Aortic Valve Replacement: A Pilot Study
PREPARE-TAVR
1 other identifier
interventional
160
1 country
1
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 older adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2019
CompletedFirst Posted
Study publicly available on registry
January 11, 2019
CompletedStudy Start
First participant enrolled
July 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2022
CompletedJanuary 13, 2021
January 1, 2021
1.5 years
January 9, 2019
January 11, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Quality of Life (QOL)
Quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ). KCCQE is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life (QOL) within a 2-week recall period. KCCQ responses are provided along a rating scale continuum with equal spacing from worst to best.
One year
Secondary Outcomes (2)
LOS
Index hospitalization
MACE
one year
Study Arms (2)
SOC
NO INTERVENTIONStandard of Care
RAPR
EXPERIMENTALRemotely administered physiological reconditioning program
Interventions
Patients assigned to intervention arm will be provided a personalized, tailored and graduated exercise program to improve physical strength and conditioning.
Eligibility Criteria
You may qualify if:
- \- Short Physical Performance Battery Protocol (SPPB) score \< 9
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Southlake Hospital
Newmarket, Ontario, Canada
Related Publications (1)
Abraham LN, Sibilitz KL, Berg SK, Tang LH, Risom SS, Lindschou J, Taylor RS, Borregaard B, Zwisler AD. Exercise-based cardiac rehabilitation for adults after heart valve surgery. Cochrane Database Syst Rev. 2021 May 7;5(5):CD010876. doi: 10.1002/14651858.CD010876.pub3.
PMID: 33962483DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Asim Cheema, MD
Unity Health Toronto
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The outcomes assessed in a blinded manner
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2019
First Posted
January 11, 2019
Study Start
July 1, 2020
Primary Completion
December 31, 2021
Study Completion
March 31, 2022
Last Updated
January 13, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share