The PERFORM-TAVR Trial

Summary

The PERFORM-TAVR trial (Protein and Exercise to Reverse Frailty in OldeR Men and women undergoing Transcatheter Aortic Valve Replacement) is a multicenter randomized clinical trial with a parallel-group design. The investigators will screen consecutive patients ≥70 years of age before TAVR and enrol those that have evidence of physical frailty defined by an SPPB score ≤8 or an SF36-PF score ≤55. The investigators will randomly allocate 200 patients to receive a multi-faceted intervention consisting of a home-based exercise program and a protein-rich oral nutritional supplement or usual lifestyle counselling. The primary endpoint will be the change in SF36-PF score at 12 weeks.

Conditions

• Frail Elderly
• Exercise
• Dietary Supplements
• Postoperative Care
• Rehabilitation
• Transcatheter Aortic Valve Replacement

Interventions

DIETARY_SUPPLEMENT

Protein-rich oral nutritional supplement

Ready-to-drink beverage containing 20 g protein and 1.5 g hydroxymethylbutyrate (HMB) per serving, consumed twice daily.

BEHAVIORAL

Home-based supervised exercise program

WEBB (Weight-bearing Exercise for Better Balance) program combining walking and weight-bearing exercises to build strength and balance, administered by a trained therapist at the participant's home.

Sponsors & Collaborators

• University of British Columbia

  collaborator OTHER

• McGill University Health Centre/Research Institute of the McGill University Health Centre

  collaborator OTHER

• St. Boniface Hospital

  collaborator OTHER

• Montreal Heart Institute

  collaborator OTHER

• Hamilton Health Sciences Corporation

  collaborator OTHER

• Ottawa Heart Institute Research Corporation

  collaborator OTHER

• Unity Health Toronto

  collaborator OTHER

• Sunnybrook Research Institute

  collaborator OTHER

• Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

  collaborator OTHER

• Centre hospitalier de l'Université de Montréal (CHUM)

  collaborator OTHER

• Jewish General Hospital

  lead OTHER

Principal Investigators

• Jonathan Afilalo, MD, MSc · Jewish General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-15

Primary Completion

2021-12-01

Completion

2022-12-01

Countries

• Canada

Study Locations