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Home-based exercise training in childhood-onset Takayasu Arteritis: a multicenter, randomized, controlled trial [with consumer summary]
Astley C, Clemente G, Terreri MT, Carneiro CG, Lima MS, Buchpiguel CA, Leao Filho H, de Sa Pinto AL, Silva CA, Campos LMA, Aikawa NE, Gil S, Pereira RMR, Roschel H, Gualano B
Frontiers in Immunology 2021 Jul 28;12(705250):Epub
clinical trial
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

INTRODUCTION: Childhood-onset Takayasu Arteritis (c-TA) is a rare, large-vessel vasculitis seen in children that could predisposing patients to a high risk of mortality. Exercise has the potential to improve overall health in several diseases, but evidence remains scant in c-TA. The main objective of this study was to investigate the safety and potential therapeutic effects of exercise in c-TA. METHODS: This was a 12-week, multicenter, randomized, controlled trial, to test the effects of a home-based, exercise intervention versus standard of care in c-TA patients in remission. The primary outcomes were arterial inflammation, assessed by (18F) FDG- PET/MRI and systemic inflammatory markers. Secondary outcomes included, physical activity levels, functionality, body composition, disease-related parameters, and quality of life. RESULTS: Thirty-seven patients were assessed for eligibility, which represents the total number of c-TA patients being followed by the three specialized medical ambulatory services in Sao Paulo. After exclusions, fourteen c-TA patients (71.4% females) aged 12 to 25 years were randomly allocated into exercised (n = 5) and non-exercised groups (n = 9). Exercise did not exacerbate arterial inflammation. In fact, exercised patients had a reduction in the frequency of vessel segments with severe inflammation, whereas the non-exercised patients had an opposite response (p = 0.007). Greater improvements in visceral fat, steps per day, functionality and physical component SF-36 were observed in the exercised patients (p <= 0.05). CONCLUSIONS: Exercise is safe and may improve visceral fat, physical activity levels, functionality, and physical component SF-36 in c-TA patients. Thus, exercise arises as a novel, evidence-based intervention to improve general health in c-TA. CLINICAL TRIAL REGISTRATION: https://www.ClinicalTrials.gov/ct2/show/NCT03494062?term=NCT03494062&draw=2&rank=1, identifier NCT03494062.

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