Exercise Intolerance, Benefits, and Prescription for People Living With a Fontan Circulation: The Fontan Fitness Intervention Trial (F-FIT)—Rationale and Design

Autor: Derek L. Tran, Hannah Gibson, Andrew J. Maiorana, Charlotte E. Verrall, David W. Baker, Melanie Clode, David R. Lubans, Diana Zannino, Andrew Bullock, Suzie Ferrie, Julie Briody, Peter Simm, Vishva Wijesekera, Michelle D'Almeida, Sally E. Gosbell, Glen M. Davis, Robert Weintraub, Anthony C. Keech, Rajesh Puranik, Martin Ugander, Robert Justo, Dominica Zentner, Avik Majumdar, Leeanne Grigg, Jeff S. Coombes, Yves d'Udekem, Norman R. Morris, Julian Ayer, David S. Celermajer, Rachael Cordina
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Zdroj: Frontiers in Pediatrics, Vol 9 (2022)
Druh dokumentu: article
ISSN: 2296-2360
DOI: 10.3389/fped.2021.799125
Popis: Background: Despite developments in surgical techniques and medical care, people with a Fontan circulation still experience long-term complications; non-invasive therapies to optimize the circulation have not been established. Exercise intolerance affects the majority of the population and is associated with worse prognosis. Historically, people living with a Fontan circulation were advised to avoid physical activity, but a small number of heterogenous, predominantly uncontrolled studies have shown that exercise training is safe—and for unique reasons, may even be of heightened importance in the setting of Fontan physiology. The mechanisms underlying improvements in aerobic exercise capacity and the effects of exercise training on circulatory and end-organ function remain incompletely understood. Furthermore, the optimal methods of exercise prescription are poorly characterized. This highlights the need for large, well-designed, multi-center, randomized, controlled trials.Aims and Methods: The Fontan Fitness Intervention Trial (F-FIT)—a phase III clinical trial—aims to optimize exercise prescription and delivery in people with a Fontan circulation. In this multi-center, randomized, controlled study, eligible Fontan participants will be randomized to either a 4-month supervised aerobic and resistance exercise training program of moderate-to-vigorous intensity followed by an 8-month maintenance phase; or usual care (control group). Adolescent and adult (≥16 years) Fontan participants will be randomized to either traditional face-to-face exercise training, telehealth exercise training, or usual care in a three-arm trial with an allocation of 2:2:1 (traditional:telehealth:control). Children (
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