Recruiting

Physiological Reconditioning

Sponsor:

Unity Health Toronto

Code:

NCT03801460

Conditions

Frailty

Transcatheter Aortic Valve Replacement

Rehabilitation

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

Interventions

Remotely administered physiological reconditioning program

Study Details

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.

Conditions

Frailty

Transcatheter Aortic Valve Replacement

Rehabilitation

Study ID

NCT03801460

Start date

Jul 1, 2020

Status verified date

Jan, 2021

Completion date

Mar 31, 2022

Anticipated

Primary completion date

Dec 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: SOC

Standard of Care

experimental: RAPR

Remotely administered physiological reconditioning program

Interventions

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.

Primary outcome measure

  • Quality of Life (QOL) [ Time Frame: One year ]

Central Contacts and Locations

Central contacts

Syed Ishba

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

Locations

Southlake Hospital

Recruiting

Newmarket, Ontario, Canada

Contacts

Asim Cheema, MD

416-620-9600acheema@southlakeregional.org

More Information

Sponsor

Unity Health Toronto

Last update posted

Jan 13, 2021

Last verified

Jan, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2021-01-13.