Clinical trial NCT03801460: Physiological Reconditioning Program Administered Remotely in Patients Undergoing Transcatheter Aortic Valve Replacement: A Pilot Study
Official title: Physiological Reconditioning Program Administered Remotely in Patients Undergoing Transcatheter Aortic Valve Replacement Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Frailty
Transcatheter Aortic Valve Replacement
Rehabilitation
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 160
Sex: ALL
Minimum age (years): 60
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, multicenter, randomized trial with objective end points assessment
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of Life (QOL)
timeFrame: One year
Secondary outcomes:
measure: LOS
timeFrame: Index hospitalization
measure: MACE
timeFrame: one year
Other outcomes:
Locations:
city: Newmarket
country: Canada
facility: Southlake Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Asim Cheema, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abraham LN, Sibilitz KL, Berg SK, Tang LH, Risom SS, Lindschou J, Taylor RS, Borregaard B, Zwisler AD. Exercise-based cardiac rehabilitation for adults after heart valve surgery. Cochrane Database Syst Rev. 2021 May 7;5(5):CD010876. doi: 10.1002/14651858.CD010876.pub3.