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

Unity Health Toronto

Status: Unknown

Conditions: Rehabilitation; Transcatheter Aortic Valve Replacement; Frailty

Treatments: Other: Remotely administered physiological reconditioning program

Study type: Interventional

Funder types: Other

Identifiers

NCT03801460

AC201810

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 60 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

SOC

No Intervention group

Description:

Standard of Care

RAPR

Experimental group

Description:

Remotely administered physiological reconditioning program

Treatment:

Other: Remotely administered physiological reconditioning program