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)

NCT06925022 | Active Not Recruiting

• 2 other identifiers: UALBIO2021/026PID2021-123447OA-I00
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Lifestyle Interventions; Menstrual Cycle; Multiple Sclerosis; Exercise; Cognitive-behavioral intervention; Physical Activity, Psychosocial Well-being; Nutrition intervention

Outcome Measures

Primary Outcomes (17)

• Satisfaction with Physical Activity

  Satisfaction with Physical Activity will be measured using an 8-item scale. Items are rated on a 5-point Likert scale ranging from 1 (Totally disagree) to 5 (Totally agree). Total scores range from 8 to 40, with higher scores indicating greater satisfaction with physical activity.

  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)

  Fatigue perception will be measured using the MFIS. This scale is a 21-item multidimensional questionnaire that evaluates the physical, cognitive, and psychosocial effects of fatigue on a five-point ordinal scale (with a maximum total score of 84).

  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)

  Fatigue perception will be measured using the MFIS. This scale is a 21-item multidimensional questionnaire that evaluates the physical, cognitive, and psychosocial effects of fatigue on a five-point ordinal scale (with a maximum total score of 84).

  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)

  Fatigue perception will be measured using the MFIS. This scale is a 21-item multidimensional questionnaire that evaluates the physical, cognitive, and psychosocial effects of fatigue on a five-point ordinal scale (with a maximum total score of 84).

  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)

  Fatigue perception will be measured using the MFIS. This scale is a 21-item multidimensional questionnaire that evaluates the physical, cognitive, and psychosocial effects of fatigue on a five-point ordinal scale (with a maximum total score of 84).

  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

  The Visual Analogue Scale for Fatigue (VAS-F) assesses subjective perceptions of fatigue on a scale from 0 to 10, where 0 indicates no fatigue at all and 10 indicates extreme fatigue. Higher scores reflect greater perceived fatigue.

  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).

• Visual Analogue Scale (VAS-F): Fatigue subscale

  The Visual Analogue Scale for Fatigue (VAS-F) assesses subjective perceptions of fatigue on a scale from 0 to 10, where 0 indicates no fatigue at all and 10 indicates extreme fatigue. Higher scores reflect greater perceived fatigue.

  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).

• Visual Analogue Scale (VAS-F): Fatigue subscale

  The Visual Analogue Scale for Fatigue (VAS-F) assesses subjective perceptions of fatigue on a scale from 0 to 10, where 0 indicates no fatigue at all and 10 indicates extreme fatigue. Higher scores reflect greater perceived fatigue.

  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).

• Visual Analogue Scale (VAS-F): Fatigue subscale

  The Visual Analogue Scale for Fatigue (VAS-F) assesses subjective perceptions of fatigue on a scale from 0 to 10, where 0 indicates no fatigue at all and 10 indicates extreme fatigue. Higher scores reflect greater perceived fatigue.

  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-E): Energy subscale

  The Visual Analogue Scale for Energy (VAS-E) assesses subjective perceptions of Energy on a scale from 0 to 10, where 0 indicates no energy at all and 10 indicates maximum energy. Higher scores reflect greater perceived energy.

  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).

• Visual Analogue Scale (VAS-E): Energy subscale

  The Visual Analogue Scale for Energy (VAS-E) assesses subjective perceptions of Energy on a scale from 0 to 10, where 0 indicates no energy at all and 10 indicates maximum energy. Higher scores reflect greater perceived energy.

  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).

• Visual Analogue Scale (VAS-E): Energy subscale

  The Visual Analogue Scale for Energy (VAS-E) assesses subjective perceptions of Energy on a scale from 0 to 10, where 0 indicates no energy at all and 10 indicates maximum energy. Higher scores reflect greater perceived energy.

  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).

• Visual Analogue Scale (VAS-E): Energy subscale

  The Visual Analogue Scale for Energy (VAS-E) assesses subjective perceptions of Energy on a scale from 0 to 10, where 0 indicates no energy at all and 10 indicates maximum energy. Higher scores reflect greater perceived energy.

  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-P): Pain subscale

  The Visual Analogue Scale for Pain (VAS-P) assesses subjective perceptions of pain on a scale from 0 to 10, where 0 indicates no pain at all and 10 indicates worst possible pain. Higher scores reflect greater perceived pain.

  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).

• Visual Analogue Scale (VAS-P): Pain subscale

  The Visual Analogue Scale for Pain (VAS-P) assesses subjective perceptions of pain on a scale from 0 to 10, where 0 indicates no pain at all and 10 indicates worst possible pain. Higher scores reflect greater perceived pain.

  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).

• Visual Analogue Scale (VAS-P): Pain subscale

  The Visual Analogue Scale for Pain (VAS-P) assesses subjective perceptions of pain on a scale from 0 to 10, where 0 indicates no pain at all and 10 indicates worst possible pain. Higher scores reflect greater perceived pain.

  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).

• Visual Analogue Scale (VAS-P): Pain subscale

  The Visual Analogue Scale for Pain (VAS-P) assesses subjective perceptions of pain on a scale from 0 to 10, where 0 indicates no pain at all and 10 indicates worst possible pain. Higher scores reflect greater perceived pain.

  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).

Secondary Outcomes (107)

• Muscle oxygen saturation (SMO2)

  During intervention 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).

• Capillary lactate concentration

  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).

• Capillary lactate concentration

  During intervention 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).

• Heart rate variability

  During intervention 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).

• Thyroid Stimulating Hormone (TSH)

  Pre-intervention (immediately before) 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).

Study Arms (2)

Women with MS

EXPERIMENTAL

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

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

Women without Multiple Sclerosis

OTHER

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

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

Interventions

Strength Training Protocol during Late Follicular Phase OTHER

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.

Women with MS; Women without Multiple Sclerosis

Strength Training during Mid-Luteal Phase OTHER

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.

Women with MS; Women without Multiple Sclerosis

Strength training session during Early Follicular Phase OTHER

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).

Women with MS; Women without Multiple Sclerosis

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Almeria: lead
• Catholic University of Murcia: collaborator
• Hospital Universitario Virgen de la Arrixaca: collaborator

Study Sites (1)

Hospital Universitario Virgen de la Arrixaca

Murcia, Murcia, 30120, Spain

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis; Motor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In this study, double blinding will be implemented to reduce bias in data collection. On one hand, the participants will not know which phase of the menstrual cycle they are in at the time of evaluation. For this purpose, the scheduling of measurements will be based on prior records. On the other hand, the researchers will also be unaware of the menstrual cycle phase. The assignment of phases and groups will be managed by an independent study coordinator who will not participate in direct evaluations. Additionally, the data will be coded to ensure that evaluators cannot identify the study variables during the measurement process.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Women with and without multiple sclerosis will participate in a strength training session during three phases of the menstrual cycle: early follicular phase, late follicular phase, and mid-luteal phase. Before and after each session, various measurements will be taken to assess physiological and performance responses.

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: April 13, 2025
• Study Start: December 15, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

ES (1)