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

Not Applicable

• Conditions: Frailty; Transcatheter Aortic Valve Replacement; Rehabilitation
• Interventions: Other: Remotely administered physiological reconditioning program

• Registration Number: NCT03801460
• Lead Sponsor: Unity Health Toronto

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.

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 Timeline

• Study First Submitted: 2019-01-09
• Study First Submitted QC: 2019-01-09
• Study First Posted: 2019-01-11
• Study Start: 2020-07-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-11
• Last Update Posted: 2021-01-13
• Primary Completion: 2021-12-31
• Study Completion: 2022-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RAPR	Remotely administered physiological reconditioning program	Remotely administered physiological reconditioning program

Primary Outcome Measures

Name	Time	Method
Quality of Life (QOL)	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

Name	Time	Method
LOS	Index hospitalization	Length of stay post TAVR
MACE	one year	Composite of mortality and repeat hospitalization

Trial Locations

Locations (1)

Southlake Hospital; 🇨🇦 Newmarket, Ontario, Canada