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) (ADVICE Phase 1)

Universidad de Almeria

Status: Active, not recruiting

Conditions: Multiple Sclerosis (MS) - Relapsing-remitting

Treatments: Other: Strength Training during Mid-Luteal Phase; Other: Strength training session during Early Follicular Phase; Other: Strength Training Protocol during Late Follicular Phase

Study type: Interventional

Funder types: Other

Identifiers

NCT06925022

PID2021-123447OA-I00 (Other Identifier)

UALBIO2021/026

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria include:

• Women of reproductive age (18-50 years) with MS will be included, with the upper age limit adjusted to reflect the reproductive phase;.
• No iron-deficiency anemia.
• Stable disease phase.
• Independent walking ability for over 10 meters.

Women will be recruited first and later matched with men based on age, EDSS, and lifestyle habits (physical activity, smoking, and alcohol consumption).

Exclusion criteria will include participants with MS who:

• Score <1 or >6 on the EDSS.
• Report a relapse within 12 months before the study begins.
• Have taken corticosteroid treatment within the last 2 months.
• Have participated in a structured training program in the previous 6 months.

Once all women with MS are recruited, male participants will be recruited following a 1:1 matching methodology based on age, geographic region, and lifestyle habits.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Women with MS

Experimental group

Description:

This arm will comprise women diagnosed with relapsing-remitting Multiple Sclerosis (RRMS) according to the McDonald criteria.

Treatment:

Other: Strength Training Protocol during Late Follicular Phase

Other: Strength training session during Early Follicular Phase

Other: Strength Training during Mid-Luteal Phase

Women without Multiple Sclerosis

Other group

Description:

This arm will comprise women without Multiple Sclerosis, matched with the MS group based on age, lifestyle habits, and geographic location.

Treatment:

Other: Strength Training Protocol during Late Follicular Phase

Other: Strength training session during Early Follicular Phase

Other: Strength Training during Mid-Luteal Phase