Physiological Reconditioning Program Administered Remotely in Patients Undergoing Transcatheter Aortic Valve Replacement: A Pilot Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2022-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Frailty Transcatheter Aortic Valve Replacement Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, multicenter, randomized trial with objective end points assessment

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The outcomes assessed in a blinded manner

Study Groups

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SOC

Standard of Care

Group Type NO_INTERVENTION

No interventions assigned to this group

RAPR

Remotely administered physiological reconditioning program

Group Type EXPERIMENTAL

Remotely administered physiological reconditioning program

Intervention Type OTHER

Patients assigned to intervention arm will be provided a personalized, tailored and graduated exercise program to improve physical strength and conditioning.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No