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

Frailty Clinical Trial

— PREPARE-TAVR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03801460
• Other study ID #: AC201810
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: March 31, 2022

Study information

• Verified date: January 2021
• Source: St. Michael's Hospital, Toronto
• Contact: Syed Ishba
• Phone: 416-620-9600
• Email: ishba.syed[@]unityhealth.to
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: March 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Frailty
• Rehabilitation
• Transcatheter Aortic Valve Replacement

Intervention

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.

Locations

Country	Name	City	State
Canada	Southlake Hospital	Newmarket	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One year
Secondary	LOS	Length of stay post TAVR	Index hospitalization
Secondary	MACE	Composite of mortality and repeat hospitalization	one year