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

Unity Health Toronto160 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

160

Conditions

Frailty Transcatheter Aortic Valve Replacement Rehabilitation

Interventions

Remotely administered physiological reconditioning programOTHER

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

Eligibility

Sex: ALLMin age: 60 YearsMax age: 95 Years

Medical Language ↔ Plain English

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

Locations (1)

Southlake Hospital

Newmarket, Ontario, Canada

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: One year

Secondary Outcomes

LOS

Length of stay post TAVR

Time frame: Index hospitalization

MACE

Composite of mortality and repeat hospitalization

Time frame: one year

Central Contacts

Syed Ishba

CONTACT

416-620-9600 ishba.syed@unityhealth.to

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.