Active — Not RecruitingNot Applicable

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)

Spain20 participantsStarted 2024-12-15

Plain-language 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.

Who can participate

Age range18 Years – 50 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Satisfaction with Physical Activity

Timeframe: Post-intervention (immediately after) in each menstrual phase: Early follicular (Days 2-5), Late follicular (Days -2 to 0, LH peak), and Mid-luteal (Days 6-9 after LH peak).

Modified Fatigue Impact Scale (MFIS)

Timeframe: Post-intervention (immediately after) in each menstrual phase: Early follicular (Days 2-5), Late follicular (Days -2 to 0, LH peak), and Mid-luteal (Days 6-9 after LH peak).

Modified Fatigue Impact Scale (MFIS)

Timeframe: Post-intervention (24 hours after) in each menstrual phase: Early follicular (Days 2-5), Late follicular (Days -2 to 0, LH peak), and Mid-luteal (Days 6-9 after LH peak).

Modified Fatigue Impact Scale (MFIS)

Timeframe: Post-intervention (48 hours after) in each menstrual phase: Early follicular (Days 2-5), Late follicular (Days -2 to 0, LH peak), and Mid-luteal (Days 6-9 after LH peak).

Modified Fatigue Impact Scale (MFIS)

Timeframe: Post-intervention (72 hours after) in each menstrual phase: Early follicular (Days 2-5), Late follicular (Days -2 to 0, LH peak), and Mid-luteal (Days 6-9 after LH peak).

Visual Analogue Scale (VAS-F): Fatigue subscale

Timeframe: Post-intervention (immediately after) in each menstrual phase: Early follicular (Days 2-5), Late follicular (Days -2 to 0, LH peak), and Mid-luteal (Days 6-9 after LH peak).

Trial details

NCT IDNCT06925022

SponsorUniversidad de Almeria

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-30

View on ClinicalTrials.gov More Multiple Sclerosis (MS) - Relapsing-remitting trials

Plain-language summary

Who can participate

Age range18 Years – 50 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Satisfaction with Physical Activity

Timeframe: Post-intervention (immediately after) in each menstrual phase: Early follicular (Days 2-5), Late follicular (Days -2 to 0, LH peak), and Mid-luteal (Days 6-9 after LH peak).

Modified Fatigue Impact Scale (MFIS)

Timeframe: Post-intervention (immediately after) in each menstrual phase: Early follicular (Days 2-5), Late follicular (Days -2 to 0, LH peak), and Mid-luteal (Days 6-9 after LH peak).

Modified Fatigue Impact Scale (MFIS)

Timeframe: Post-intervention (24 hours after) in each menstrual phase: Early follicular (Days 2-5), Late follicular (Days -2 to 0, LH peak), and Mid-luteal (Days 6-9 after LH peak).

Modified Fatigue Impact Scale (MFIS)

Timeframe: Post-intervention (48 hours after) in each menstrual phase: Early follicular (Days 2-5), Late follicular (Days -2 to 0, LH peak), and Mid-luteal (Days 6-9 after LH peak).

Modified Fatigue Impact Scale (MFIS)

Timeframe: Post-intervention (72 hours after) in each menstrual phase: Early follicular (Days 2-5), Late follicular (Days -2 to 0, LH peak), and Mid-luteal (Days 6-9 after LH peak).

Visual Analogue Scale (VAS-F): Fatigue subscale

Timeframe: Post-intervention (immediately after) in each menstrual phase: Early follicular (Days 2-5), Late follicular (Days -2 to 0, LH peak), and Mid-luteal (Days 6-9 after LH peak).