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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)

NCT ID: NCT06925022

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-15

Study Completion Date

2026-02-15

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis (MS) - Relapsing-remitting

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.

Study Groups

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Women with MS

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

Group Type EXPERIMENTAL

Strength training session during Early Follicular Phase

Intervention Type 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).

Strength Training Protocol during Late Follicular Phase

Intervention Type 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.

Strength Training during Mid-Luteal Phase

Intervention Type 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 without Multiple Sclerosis

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

Group Type OTHER

Strength training session during Early Follicular Phase

Intervention Type 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).

Strength Training Protocol during Late Follicular Phase

Intervention Type 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.

Strength Training during Mid-Luteal Phase

Intervention Type 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.

Interventions

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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).

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Catholic University of Murcia

OTHER

Sponsor Role collaborator

Hospital Universitario Virgen de la Arrixaca

OTHER

Sponsor Role collaborator

Universidad de Almeria

OTHER

Sponsor Role lead

Responsible Party

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Jacobo Á. Rubio-Arias

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Universitario Virgen de la Arrixaca

Murcia, Murcia, Spain

Site Status

Countries

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Spain

Other Identifiers

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PID2021-123447OA-I00

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

UALBIO2021/026

Identifier Type: -

Identifier Source: org_study_id