NCT06925022

Educational Programs Based on Healthy Habits to Improve Quality of Life and Psychosocial Profile in Women With Neurodegenerative Diseases: The ADVICE Protocol Study (Phase 1)

Educational Programs Based on Healthy Habits to Improve Quality of Life and Psychosocial Profile in Women With Neurodegenerative Diseases: The ADVICE Protocol Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Universidad de Almeria · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This phase of the project aims to analyze the interaction between physical exercise and the phases of the menstrual cycle, evaluating its impact on fatigue, functional capacity, and exercise perception in women with and without Multiple Sclerosis. To achieve this, a controlled, single-blind, prospective, 2x3 crossover, randomized clinical trial will be conducted, involving women with Multiple Sclerosis (MS), matched by age, lifestyle habits (smoking, physical activity), and geographic location with a group of women without MS. This study, aligned with previous findings, seeks to deepen the understanding of the role of exercise in managing Multiple Sclerosis symptoms and to promote greater adherence to personalized physical activity programs adapted to the phases of the menstrual cycle.

Conditions

• Multiple Sclerosis (MS) - Relapsing-remitting

Interventions

Type	Name	Description
OTHER	Strength training session during Early Follicular Phase	The strength training sessions follow guidelines and recent meta-analyses to optimize long-term outcomes. Participants will complete a standardized warm-up protocol consisting of 5 minutes on a stationary bike, lower limb mobility exercises, and 5 repetitions at 40% of their 1-RM on each machine before each strength training session. Subsequently, they will perform four exercises for the lower limbs, including bilateral leg press, unilateral leg extension, unilateral hip extension, and plantar flexion, using conventional weight machines (. Session intensity will be set at 70-75% of 1-RM, with a volume of 4 sets of 10 repetitions, leaving 1-2 reps in reserve (RIR), and with 120 seconds of rest between sets. This phase occurs at the beginning of the menstrual cycle (days 2-5 after the onset of menstruation).
OTHER	Strength Training Protocol during Late Follicular Phase	The strength training sessions follow guidelines and recent meta-analyses to optimize long-term outcomes. Participants will complete a standardized warm-up protocol consisting of 5 minutes on a stationary bike, lower limb mobility exercises, and 5 repetitions at 40% of their 1-RM on each machine before each strength training session. Subsequently, they will perform four exercises for the lower limbs, including bilateral leg press, unilateral leg extension, unilateral hip extension, and plantar flexion, using conventional weight machines (. Session intensity will be set at 70-75% of 1-RM, with a volume of 4 sets of 10 repetitions, leaving 1-2 reps in reserve (RIR), and with 120 seconds of rest between sets. This phase occurs approximately between days 11-13 of the menstrual cycle.
OTHER	Strength Training during Mid-Luteal Phase	The strength training sessions follow guidelines and recent meta-analyses to optimize long-term outcomes. Participants will complete a standardized warm-up protocol consisting of 5 minutes on a stationary bike, lower limb mobility exercises, and 5 repetitions at 40% of their 1-RM on each machine before each strength training session. Subsequently, they will perform four exercises for the lower limbs, including bilateral leg press, unilateral leg extension, unilateral hip extension, and plantar flexion, using conventional weight machines (. Session intensity will be set at 70-75% of 1-RM, with a volume of 4 sets of 10 repetitions, leaving 1-2 reps in reserve (RIR), and with 120 seconds of rest between sets. This phase occurs around days 19-28 of the menstrual cycle, following ovulation.

Timeline

• Start date: 2024-12-15
• Primary completion: 2026-05-30
• Completion: 2026-05-30
• First posted: 2025-04-13
• Last updated: 2026-03-24

Locations

1 site across 1 country: Spain