- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03801460
Physiological Reconditioning Program Administered Remotely in Patients Undergoing Transcatheter Aortic Valve Replacement: A Pilot Study (PREPARE-TAVR)
January 11, 2021 updated by: Unity Health Toronto
Physiological Reconditioning Program Administered Remotely in Patients Undergoing Transcatheter Aortic Valve Replacement Pilot Study
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.
Study Overview
Status
Unknown
Intervention / Treatment
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 Transcatheter aortic valve replacement (TAVR) procedures.
Patients will be randomly (1:1) assigned to the standard of care (SOC group) where patients will receive all medical care as decided by their treating physicians or assigned to a home based program known as remotely administered physiological reconditioning (RPR) program which will include receiving personalized instructions for a progressive exercise program and dietary changes.
Patients will be contacted for regular phone and in-person follow up for monitoring their progress.
The primary endpoint will be quality of life as assessed by KCCQE questionnaires at one-year post TAVR.
The secondary endpoints include length of stay post TAVR, all-cause mortality, repeat hospitalization and a composite of all-cause mortality and repeat hospitalization at one year.
Study Type
Interventional
Enrollment (Anticipated)
160
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Syed Ishba
- Phone Number: 416-620-9600
- Email: ishba.syed@unityhealth.to
Study Locations
-
-
Ontario
-
Newmarket, Ontario, Canada
- Recruiting
- Southlake Hospital
-
Contact:
- Asim Cheema, MD
- Phone Number: 416-620-9600
- Email: acheema@southlakeregional.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 95 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Short Physical Performance Battery Protocol (SPPB) score < 9
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: SOC
Standard of Care
|
|
EXPERIMENTAL: RAPR
Remotely administered physiological reconditioning program
|
Patients assigned to intervention arm will be provided a personalized, tailored and graduated exercise program to improve physical strength and conditioning.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life (QOL)
Time Frame: One year
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
LOS
Time Frame: Index hospitalization
|
Length of stay post TAVR
|
Index hospitalization
|
MACE
Time Frame: one year
|
Composite of mortality and repeat hospitalization
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 1, 2020
Primary Completion (ANTICIPATED)
December 31, 2021
Study Completion (ANTICIPATED)
March 31, 2022
Study Registration Dates
First Submitted
January 9, 2019
First Submitted That Met QC Criteria
January 9, 2019
First Posted (ACTUAL)
January 11, 2019
Study Record Updates
Last Update Posted (ACTUAL)
January 13, 2021
Last Update Submitted That Met QC Criteria
January 11, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AC201810
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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