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Physiological Reconditioning Program Administered Remotely in Patients Undergoing Transcatheter Aortic Valve Replacement: A Pilot Study (PREPARE-TAVR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03801460
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : January 13, 2021
Sponsor:
Information provided by (Responsible Party):
Unity Health Toronto

Study Description
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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.

Condition or disease Intervention/treatment Phase
Frailty Transcatheter Aortic Valve Replacement Rehabilitation Other: Remotely administered physiological reconditioning program Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, multicenter, randomized trial with objective end points assessment
Masking: Single (Outcomes Assessor)
Masking Description: The outcomes assessed in a blinded manner
Primary Purpose: Treatment
Official Title: Physiological Reconditioning Program Administered Remotely in Patients Undergoing Transcatheter Aortic Valve Replacement Pilot Study
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : March 31, 2022
Arms and Interventions
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Arm Intervention/treatment
No Intervention: SOC
Standard of Care
Experimental: RAPR
Remotely administered physiological reconditioning program
 Other: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. LOS [ Time Frame: Index hospitalization ]
    Length of stay post TAVR

  2. MACE [ Time Frame: one year ]
    Composite of mortality and repeat hospitalization


Eligibility Criteria
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Ages Eligible for Study:   60 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03801460


Contacts
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Contact: Syed Ishba 416-620-9600 ishba.syed@unityhealth.to

Locations
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Canada, Ontario
Southlake Hospital Recruiting
Newmarket, Ontario, Canada
Contact: Asim Cheema, MD    416-620-9600    acheema@southlakeregional.org   
Sponsors and Collaborators
Unity Health Toronto
Investigators
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Principal Investigator: Asim Cheema, MD Unity Health Toronto
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Unity Health Toronto
ClinicalTrials.gov Identifier: NCT03801460    
Other Study ID Numbers: AC201810
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: January 13, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Frailty
Pathologic Processes