Protein and Exercise to Reverse Frailty in Older Men and Women Undergoing Transcatheter Aortic Valve Replacement: Design of the PERFORM-TAVR Trial.
Frailty
exercise
nutrition
randomized trial
transcatheter aortic valve replacement
Journal
The Canadian journal of cardiology
ISSN: 1916-7075
Titre abrégé: Can J Cardiol
Pays: England
ID NLM: 8510280
Informations de publication
Date de publication:
03 Dec 2023
03 Dec 2023
Historique:
received:
07
08
2023
revised:
27
11
2023
accepted:
29
11
2023
medline:
6
12
2023
pubmed:
6
12
2023
entrez:
5
12
2023
Statut:
aheadofprint
Résumé
Despite the high procedural success of transcatheter aortic valve replacement (TAVR), 2 out of 5 older adults report poor physical performance and health-related quality of life (HRQOL) in the ensuing months, particularly those with frailty. There has yet to be a trial examining the synergistic effects of exercise and protein supplementation to counteract frailty and improve patient-centered outcomes following TAVR. The PERFORM-TAVR trial is a multicenter parallel-group randomized clinical trial that is enrolling 200 frail older adults ≥70 years undergoing TAVR (NCT03522454). Patients will be randomly allocated to one of two treatment groups: standard-of-care lifestyle education (control group) or protein-rich oral nutritional supplement for 4 weeks pre-TAVR with the addition of home-based supervised exercise sessions for 12 weeks post-TAVR (intervention group). The primary outcome will be physical performance as measured by a blinded observer using the Short Physical Performance Battery at 3 months. Secondary outcomes at 3, 6, and 12 months will include HRQOL as measured by the Short-Form 36 Physical and Mental Component summary scores, and a composite safety endpoint. The PERFORM-TAVR trial is testing a novel frailty intervention in older adults undergoing TAVR to optimize recovery and downstream HRQOL. This represents a potential paradigm shift that highlights the value of assessing and treating patient's frailty in parallel with their underlying heart valve disease.
Sections du résumé
BACKGROUND
BACKGROUND
Despite the high procedural success of transcatheter aortic valve replacement (TAVR), 2 out of 5 older adults report poor physical performance and health-related quality of life (HRQOL) in the ensuing months, particularly those with frailty. There has yet to be a trial examining the synergistic effects of exercise and protein supplementation to counteract frailty and improve patient-centered outcomes following TAVR.
METHODS
METHODS
The PERFORM-TAVR trial is a multicenter parallel-group randomized clinical trial that is enrolling 200 frail older adults ≥70 years undergoing TAVR (NCT03522454). Patients will be randomly allocated to one of two treatment groups: standard-of-care lifestyle education (control group) or protein-rich oral nutritional supplement for 4 weeks pre-TAVR with the addition of home-based supervised exercise sessions for 12 weeks post-TAVR (intervention group). The primary outcome will be physical performance as measured by a blinded observer using the Short Physical Performance Battery at 3 months. Secondary outcomes at 3, 6, and 12 months will include HRQOL as measured by the Short-Form 36 Physical and Mental Component summary scores, and a composite safety endpoint.
CONCLUSIONS
CONCLUSIONS
The PERFORM-TAVR trial is testing a novel frailty intervention in older adults undergoing TAVR to optimize recovery and downstream HRQOL. This represents a potential paradigm shift that highlights the value of assessing and treating patient's frailty in parallel with their underlying heart valve disease.
Identifiants
pubmed: 38052302
pii: S0828-282X(23)01964-5
doi: 10.1016/j.cjca.2023.11.037
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
Copyright © 2023. Published by Elsevier Inc.