The PERFORM-TAVR Trial
PERFORM-TAVR
Protein and Exercise to Reverse Frailty in OlderR Men and Women Undergoing TAVR: The PERFORM-TAVR Trial
1 other identifier
interventional
200
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2018
CompletedFirst Posted
Study publicly available on registry
May 11, 2018
CompletedStudy Start
First participant enrolled
March 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedOctober 9, 2020
October 1, 2020
2.7 years
April 17, 2018
October 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
SF36-PF
Short-Form 36 Physical Functioning (SF36-PF) scale; range 0-100 (higher is better)
3 months
Secondary Outcomes (11)
SPPB
3 and 6 months
Health-related quality of life
3, 6, and 12 months
Habitual physical activity (in kcal per week)
3, 6, and 12 months
Frailty
3 and 6 months
Sarcopenia
3, 6, and 12 months
- +6 more secondary outcomes
Study Arms (2)
Intervention group
EXPERIMENTALIntervention group: Combination of a protein-rich oral nutritional supplement consumed twice daily for 4 weeks pre-TAVR and 12 weeks after the patient is discharged home post-TAVR, and a home-based supervised exercise program that combines walking and weight-bearing exercises to build strength and balance performed for 12 weeks after the patient is discharged home post-TAVR.
Lifestyle counselling group
NO INTERVENTIONLifestyle counselling group: Recommendation to perform moderate-intensity aerobic activity at least 30 minutes 5 days per week as tolerated and eat a balanced diet based on the AHA/ACC Guideline on Lifestyle Management.
Interventions
Ready-to-drink beverage containing 20 g protein and 1.5 g hydroxymethylbutyrate (HMB) per serving, consumed twice daily.
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.
Eligibility Criteria
You may qualify if:
- Age ≥70 years
- Undergoing TAVR
- Physically frail: SPPB score ≤8 or SF36-PF score ≤ 55 pre-TAVR
- Informed written or verbal consent
You may not qualify if:
- Decompensated or non-ambulatory class IV symptoms of angina, dyspnea, claudication
- Uncontrolled diabetes with HbA1C \>8.5% (or mean glucose ≥11.0 in the absence of a HbA1C test)
- Glomerular filtration rate (GFR) \<30 mL/min/1.73 m2 by the MDRD equation
- Cirrhosis
- Allergy to ingredient in beverage
- Inability to safely ingest beverage by mouth
- Inability to walk without human assistance or high-risk of falls
- Moderate-to-severe cognitive impairment
- Significant language barrier
- COVID positive or suspected at screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jewish General Hospitallead
- University of British Columbiacollaborator
- McGill University Health Centre/Research Institute of the McGill University Health Centrecollaborator
- St. Boniface Hospitalcollaborator
- Montreal Heart Institutecollaborator
- Hamilton Health Sciences Corporationcollaborator
- Ottawa Heart Institute Research Corporationcollaborator
- Unity Health Torontocollaborator
- Sunnybrook Research Institutecollaborator
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montrealcollaborator
- Centre hospitalier de l'Université de Montréal (CHUM)collaborator
Study Sites (1)
Jewish General Hospital / McGill University Health Centre
Montreal, Quebec, H3T 1E2, Canada
Related Publications (1)
Fountotos R, Lauck S, Piazza N, Martucci G, Arora R, Asgar A, Forcillo J, Kouz R, Labinaz M, Lamy A, Peterson M, Wijeysundera H, Masse L, Ouimet MC, Polderman J, Webb J, Afilalo J. Protein and Exercise to Reverse Frailty in Older Men and Women Undergoing Transcatheter Aortic Valve Replacement: Design of the PERFORM-TAVR Trial. Can J Cardiol. 2024 Feb;40(2):267-274. doi: 10.1016/j.cjca.2023.11.037. Epub 2023 Dec 3.
PMID: 38052302DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan Afilalo, MD, MSc
Jewish General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The outcome assessor who will perform the 3 and 6 month visits will be blinded to the participant's assigned intervention.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 17, 2018
First Posted
May 11, 2018
Study Start
March 15, 2019
Primary Completion
December 1, 2021
Study Completion
December 1, 2022
Last Updated
October 9, 2020
Record last verified: 2020-10