NCT03801460

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 60 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Frailty
• Transcatheter Aortic Valve Replacement
• Rehabilitation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-07-01
• Primary completion: 2021-12-31
• Completion: 2022-03-31
• First posted: 2019-01-11
• Last updated: 2021-01-13

Locations

1 site across 1 country: Canada