Response to physical activity of females with multiple sclerosis throughout the menstrual cycle: a protocol for a randomised crossover trial (EMMA Project)

Abstract

The relationship between multiple sclerosis (MS) and females is a crucial aspect in the development of the disease, with the ovarian hormonal cycle being a sensitive stage, especially in females with relapsing-remitting multiple sclerosis. The objectives of the study are to identify moderating variables that modify satisfaction with physical activity practice throughout the menstrual cycle (MC) in females in or out of their MC, during high-intensity interval training (HIIT) and strength training sessions and to compare the acute effects of different types of physical activity sessions in females with and without MS. This protocol is the methodology used in the EMMA Study, a randomised, single-blind crossover trial study conducted in females with MS who were matched 1:1, based on age, lifestyle factors and country of residence, with females without MS, to analyse the effect of physical activity practice on satisfaction, functionality, fatigue and inflammatory profile through their MC. Participants will visit the facilities approximately 10 times (4 preliminary familiarisation visits and 6 visits to carry out a physical activity session in each phase of the MC) for 3–4 months. A total sample of 30 females (15 females without MS and 15 with MS) is necessary for the study. The evaluation will comprise clinical, nutritional and psychological interviews, including different variables. It is hypothesised during the luteal phase, females with MS are expected to exhibit different acute responses to HIIT and strength training sessions as compared with females without the disease. Before starting the study, all participants will read and sign an informed consent form. Trial registration number: This research protocol is registered with ClinicalTrials.gov to ensure transparency and accessibility of study information (NCT06105463). The university’s ethics committee number for this study is UALBIO2022/048.