NCT03522454|UnknownDMC
The PERFORM-TAVR Trial
PERFORM-TAVR
Protein and Exercise to Reverse Frailty in OlderR Men and Women Undergoing TAVR: The PERFORM-TAVR Trial
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PERFORM-TAVR
Protein and Exercise to Reverse Frailty in OlderR Men and Women Undergoing TAVR: The PERFORM-TAVR Trial
Sponsor study identifier
interventional
200
1 country
1
Study Start
March 15, 2019
Actual (reported)Primary Completion
December 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 17, 2018
Actual (reported)May 11, 2018
Actual (reported)March 15, 2019
Actual (reported)December 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
SF36-PF
Short-Form 36 Physical Functioning (SF36-PF) scale; range 0-100 (higher is better)
3 months
SPPB
3 and 6 months
Health-related quality of life
3, 6, and 12 months
Habitual physical activity (in kcal per week)
Intervention 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: 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.
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.
Jewish General Hospital / McGill University Health Centre
Montreal, Quebec, H3T 1E2, Canada
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.
Jonathan Afilalo, MD, MSc
Jewish General Hospital
First Submitted
April 17, 2018
First Posted
May 11, 2018
Study Start
March 15, 2019
Actual (reported)Primary Completion
3, 6, and 12 months
Frailty
3 and 6 months
Sarcopenia
3, 6, and 12 months
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
December 1, 2021
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 9, 2020
Record last verified: 2020-10
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Source: ClinicalTrials.gov.
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