Contemporary clinical trials · 2026
Educational programs based on healthy habits to improve quality of life and psychosocial profile in women with multiple sclerosis: The ADVICE protocol study.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Rubio-Arias Jacobo Á, Ramos-Campo Domingo Jesús, Andreu-Caravaca Luis, Cupeiro Rocío, Marín-Jiménez Nuria, Romero-Parra Nuria, Meca-Lallana Jose E, Martínez-Rodríguez Alejandro, Gonzálvez-Alvarado Lucía, Muñoz-Villena Antonio J, Lara-Sánchez Amador J, Benítez-Muñoz José Antonio, López-Liria Remedios, Molina-Torres Guadalupe, Iniesta-Martínez Francisca, Valero López Gabriel, Ferrer Contreras María Del Carmen, López Román Javier, Ávila-Gandía Vicente
Аннотация
BACKGROUND: Multiple sclerosis (MS) is a chronic neurological disease primarily affecting young women. Fatigue, one of its most disabling symptoms, significantly impairs quality of life. The influence of menstrual cycle (MC) fluctuations on fatigue perception, physical activity participation, and daily living remains unclear. Multidisciplinary educational programs combining exercise, nutrition, and cognitive-behavioral therapy (CBT) show promise, but optimal delivery -supervised individualized vs. self-guided online- is unknown. The ADVICE project protocol addresses two objectives: (a) examine MC phase effects on fatigue, physical activity satisfaction, and strength training responses in women with relapsing-remitting MS (RRMS) and without MS (Phase 1); (b) compare supervised vs. self-guided programs on fatigue, functional capacity, and psychosocial well-being in people with RRMS (Phase 2).
METHODS: This protocol was developed in accordance with the SPIRIT guidelines, and the subsequent trial results will be reported following the CONSORT recommendations. Phase 1 is a randomized, controlled, crossover trial in eumenorrheic women with RRMS or without MS, to analyze fatigue and training responses across MC. Phase 2 is a randomized controlled trial comparing a supervised multidisciplinary program with a self-guided online intervention. Both phases will employ mixed ANOVA analyses with appropriate adjustments for covariates.
CONCLUSIONS: This study will provide novel insights into how MC influence fatigue, physical activity satisfaction, and strength training responses in women with RRMS and without MS, as well as the comparative effects of supervised versus self-guided multidisciplinary programs on fatigue, functional capacity, and psychosocial outcomes in people with RRMS.
CLINICAL TRIALS REGISTRATION: Phase 1 (NCT06925022). Data of registration: 15-12-2024. Phase2 (NCT06884579). Data of registration: 15-12-2025.
METHODS: This protocol was developed in accordance with the SPIRIT guidelines, and the subsequent trial results will be reported following the CONSORT recommendations. Phase 1 is a randomized, controlled, crossover trial in eumenorrheic women with RRMS or without MS, to analyze fatigue and training responses across MC. Phase 2 is a randomized controlled trial comparing a supervised multidisciplinary program with a self-guided online intervention. Both phases will employ mixed ANOVA analyses with appropriate adjustments for covariates.
CONCLUSIONS: This study will provide novel insights into how MC influence fatigue, physical activity satisfaction, and strength training responses in women with RRMS and without MS, as well as the comparative effects of supervised versus self-guided multidisciplinary programs on fatigue, functional capacity, and psychosocial outcomes in people with RRMS.
CLINICAL TRIALS REGISTRATION: Phase 1 (NCT06925022). Data of registration: 15-12-2024. Phase2 (NCT06884579). Data of registration: 15-12-2025.