NCT06105463

Multiple Sclerosis, Menstrual Cycle and Physical Acivity

Response to Physical Activity in Women With Multiple Sclerosis Throughout the Menstrual Cycle (EMMA Project)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Universidad de Almeria · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This study aims to identify moderating variables that modify satisfaction with physical activity practice throughout the menstrual cycle (MC) in women with and without multiple sclerosis (MS) during High-Intensity Interval Training (HIIT) and strength training sessions, and to compare the acute effects of different types of physical activity sessions in women with and without MS. This study used a randomized crossover trial study and single-blind performed by women with MS, matched 1:1 based on age, lifestyle factors and country of residence, with women without MS to analyse the effect of physical activity practise on satisfaction, functionality, fatigue, and inflammatory profile throughout MC. Participants will visit the facilities approximately 10 times (4 preliminary familiarization visits and 6 visits to carry out a physical activity session in each phase of the MC) over a period of 3-4 months. Evaluation will comprise clinical, nutritional and psychological interviews including different variables such as satisfaction on physical activity; visual analogue scale of fatigue; abdominal obesity and anthropometric variables; dietary and nutritional monitoring; bioimpedance analysis; blood profile of hormone, inflammatory and cognitive function blood profile; neuromuscular strength, voluntary activation, and contractile properties; functional assessment (spasticity, knee angles, gait speed, walking endurance, balance, sit-to-stand test, timed up and go test); rating of perceived exertion; pain; muscle oxygen saturation; lactate; heart rate variability; quality of sleep and life; and body temperature. During the luteal phase, women with MS are expected to exhibit different acute responses to HIIT and strength training sessions compared to women without the disease.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
OTHER	Strength training sessions and High-interval intensity training sessions	During strength training sessions, participants will perform 4 lower limb exercises, including bilateral leg press, unilateral leg extension, unilateral hip extension, and bilateral seated calf raise on conventional weight machines. The intensity of the session will be 70-75% of 1-RM, 4 sets, 10 repetitions (1-2 RIR) and 120 seconds rest between sets. During High-interval intensity training (HIIT) sessions, participants will perform 10 minutes of warm-up at 50% of peak power + 20 minutes of HIIT consisting of 30 seconds at 90% of peak power followed by 30 seconds of rest + 10 minutes of cool-down at 35-40% of peak power in cycloergometer.

Timeline

• Start date: 2024-05-06
• Primary completion: 2024-11-30
• Completion: 2024-12-30
• First posted: 2023-10-27
• Last updated: 2026-03-25

Locations

1 site across 1 country: Spain