Educational Programs Based on Healthy Habits to Improve Quality of Life and Psychosocial Profile in Women With Neurodegenerative Diseases: The ADVICE Protocol Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universidad de Almeria
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Modified Fatigue Impact Scale (MFIS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
- •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.
Arms & Interventions
Women with MS
This arm will comprise women diagnosed with relapsing-remitting Multiple Sclerosis (RRMS) according to the McDonald criteria.
Intervention: Strength training session during Early Follicular Phase (Other)
Women with MS
This arm will comprise women diagnosed with relapsing-remitting Multiple Sclerosis (RRMS) according to the McDonald criteria.
Intervention: Strength Training Protocol during Late Follicular Phase (Other)
Women with MS
This arm will comprise women diagnosed with relapsing-remitting Multiple Sclerosis (RRMS) according to the McDonald criteria.
Intervention: Strength Training during Mid-Luteal Phase (Other)
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.
Intervention: Strength training session during Early Follicular Phase (Other)
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.
Intervention: Strength Training Protocol during Late Follicular Phase (Other)
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.
Intervention: Strength Training during Mid-Luteal Phase (Other)
Outcomes
Primary Outcomes
Modified Fatigue Impact Scale (MFIS)
Time Frame: 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).
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).
Modified Fatigue Impact Scale (MFIS)
Time Frame: 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).
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).
Modified Fatigue Impact Scale (MFIS)
Time Frame: 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).
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).
Visual Analogue Scale (VAS-F): Fatigue subscale
Time Frame: 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).
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.
Visual Analogue Scale (VAS-F): Fatigue subscale
Time Frame: 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).
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.
Visual Analogue Scale (VAS-F): Fatigue subscale
Time Frame: 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).
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.
Visual Analogue Scale (VAS-E): Energy subscale
Time Frame: 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).
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.
Visual Analogue Scale (VAS-E): Energy subscale
Time Frame: 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).
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.
Visual Analogue Scale (VAS-E): Energy subscale
Time Frame: 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).
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.
Visual Analogue Scale (VAS-P): Pain subscale
Time Frame: 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).
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.
Visual Analogue Scale (VAS-P): Pain subscale
Time Frame: 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).
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.
Visual Analogue Scale (VAS-P): Pain subscale
Time Frame: 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).
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.
Satisfaction with Physical Activity
Time Frame: 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).
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.
Modified Fatigue Impact Scale (MFIS)
Time Frame: 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).
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).
Visual Analogue Scale (VAS-F): Fatigue subscale
Time Frame: 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).
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.
Visual Analogue Scale (VAS-E): Energy subscale
Time Frame: 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).
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.
Visual Analogue Scale (VAS-P): Pain subscale
Time Frame: 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).
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.
Secondary Outcomes
- Interleukin-10 (IL-10)(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).)
- Central activation ratio(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).)
- 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).)
- 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).)
- Interferon-gamma (IFN-γ)(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).)
- Cognitive Function(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).)
- Upper Limb Maximum Strength(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).)
- Neurofilament Light Chain (NFL)(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).)
- Rate of force development(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).)
- Maximum Voluntary Isometric Contraction(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).)
- Maximal neural drive(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).)
- Spasticity(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).)
- Intrinsic muscle characteristics: Tone (F)(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).)
- Gait speed(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).)
- Static balance with eyes open(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).)
- Interleukin-6 (IL-6)(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).)
- Static balance with eyes closed(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).)
- Sit-to-stand(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).)
- Timed Up-and-Go test(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).)
- Delayed onset muscle soreness(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).)
- Delayed onset muscle soreness(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).)
- Delayed onset muscle soreness(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).)
- Delayed onset muscle soreness(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).)
- Subjective Perception of Effort(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).)
- Subjective Perception of Effort(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).)
- Tumor Necrosis Factor-alpha (TNF-α)(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).)
- Fatigue Visual Analog Scale (VAS-F)(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).)
- Fatigue Visual Analog Scale (VAS-F)(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).)
- Fatigue Visual Analog Scale (VAS-F)(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).)
- Adherence to the Mediterranean Diet assessed by MEDAS(Baseline (pre-intervention))
- The Kurtzke Disability Scale(Baseline (pre-intervention).)
- Subjective Sleep Quality Questionnaire(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).)
- Subjective Sleep Quality Questionnaire(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).)
- Subjective Sleep Quality Questionnaire(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).)
- Subjective Sleep Quality Questionnaire(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).)
- Sleep Quality Measured by Actigraph(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).)
- Sleep Quality Measured by Actigraph(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).)
- Sleep Quality Measured by Actigraph(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).)
- Sleep Quality Measured by Actigraph(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).)
- Transforming Growth Factor Beta 1 (TGF-β1)(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).)
- Intrinsic muscle characteristics: Stiffness (S)(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).)
- Intrinsic muscle characteristics: Elasticity (D)(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).)
- Intrinsic muscle characteristics: Relaxation (R)(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).)
- Intrinsic muscle characteristics: Creep (C)(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).)
- Nutrient Intake assessed by 3-Day Food Diary(Baseline (pre-intervention))
- Heart rate variability(Post-intervention (first night) 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(Post-intervention (24 hours after, i.e., the second night) 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(Post-intervention (48 hours after, i.e., the third night) 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).)
- Timed Up-and-Go test(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).)
- Interferon-gamma (IFN-γ)(Post-intervention (30 min 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).)
- Cognitive Function(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).)
- 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).)
- Heart rate variability(Post-intervention (72 hours after, i.e., the fourth night) 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).)
- Neurofilament Light Chain (NFL)(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).)
- Physical Self-Perception (PSP)(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).)
- Pain Catastrophizing Scale (PCS)(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).)
- Quality of Life questionnaire (MSQOL-54)(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).)
- State-Trait Anxiety (STAI)(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).)
- Rate of force development(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).)
- Maximum Voluntary Isometric Contraction(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).)
- Maximal neural drive(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).)
- Central activation ratio(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).)
- Upper Limb Maximum Strength(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).)
- Spasticity(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).)
- Intrinsic muscle characteristics: Tone (F)(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).)
- Gait speed(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).)
- Static balance with eyes open(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).)
- Static balance with eyes closed(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).)
- Sit-to-stand(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).)
- Delayed onset muscle soreness(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).)
- Subjective Perception of Effort (RPE)(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).)
- Subjective Perception of Effort(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).)
- Fatigue Visual Analog Scale (VAS-F)(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 for Fatigue (VAS-F)(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).)
- Body Weight(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).)
- Adherence to the Mediterranean Diet assessed by MEDAS(Post-intervention (48 hours after the last session))
- Physical Activity Level assessed by the International Physical Activity Questionnaire (IPAQ)(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).)
- The Kurtzke Disability Scale(Post-intervention (48 hours after the last session).)
- Intrinsic muscle characteristics: Elasticity (D)(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).)
- Subjective Sleep Quality Questionnaire(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).)
- Sleep Quality Measured by Actigraph(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).)
- Progesterone (PG)(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).)
- Luteinizing Hormone (LH)(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).)
- Follicle-Stimulating Hormone (FSH)(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).)
- Estradiol (E2)(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).)
- Testosterone (T)(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).)
- Interleukin-6 (IL-6)(Post-intervention (30 min 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).)
- Tumor Necrosis Factor-alpha (TNF-α)(Post-intervention (30 min 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).)
- Interleukin-10 (IL-10)(Post-intervention (30 min 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).)
- Transforming Growth Factor Beta 1 (TGF-β1)(Post-intervention (30 min 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).)
- Intrinsic muscle characteristics: Stiffness (S)(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).)
- Intrinsic muscle characteristics: Relaxation (R)(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).)
- Intrinsic muscle characteristics: Creep (C)(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).)
- Height(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).)
- Body Mass Index (BMI)(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).)
- Physical Activity Level assessed by Triaxial Accelerometer(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).)
- Nutrient Intake assessed by 3-Day Food Diary(Post-intervention (48 hours after the last session))
- Lean Mass (%)(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).)
- Lean Mass (kg)(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).)
- Bone Mineral Content (BMC)(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).)
- Bone Mineral Density (BMD)(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).)
- Body Water(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).)
- Phase Angle(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).)
- Fat Mass (kg)(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).)
- Fat Mass (%)(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).)
Investigators
Jacobo Á. Rubio-Arias
Principal Investigator
Universidad de Almeria