Clinical trial NCT06925022: 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)
Official title: Educational Programs Based on Healthy Habits to Improve Quality of Life and Psychosocial Profile in Women With Neurodegenerative Diseases: The ADVICE Protocol Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis (MS) - Relapsing-remitting
Keywords: Lifestyle Interventions
Menstrual Cycle
Multiple Sclerosis
Exercise
Cognitive-behavioral intervention
Physical Activity, Psychosocial Well-being
Nutrition intervention
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
Collaborators: name: Catholic University of Murcia
name: Hospital Universitario Virgen de la Arrixaca
First posted: 2025-04-13
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: 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).
measure: 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).
measure: 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).
measure: 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).
measure: 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).
measure: 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).
measure: Visual Analogue Scale (VAS-F): Fatigue subscale
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).
measure: Visual Analogue Scale (VAS-F): Fatigue subscale
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).
measure: Visual Analogue Scale (VAS-F): Fatigue subscale
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).
measure: Visual Analogue Scale (VAS-E): Energy 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).
measure: Visual Analogue Scale (VAS-E): Energy subscale
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).
measure: Visual Analogue Scale (VAS-E): Energy subscale
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).
measure: Visual Analogue Scale (VAS-E): Energy subscale
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).
measure: Visual Analogue Scale (VAS-P): Pain 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).
measure: Visual Analogue Scale (VAS-P): Pain subscale
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).
measure: Visual Analogue Scale (VAS-P): Pain subscale
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).
measure: Visual Analogue Scale (VAS-P): Pain subscale
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).
Secondary outcomes:
measure: Muscle oxygen saturation (SMO2)
timeFrame: 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).
measure: Capillary lactate concentration
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).
measure: Capillary lactate concentration
timeFrame: 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).
measure: Heart rate variability
timeFrame: 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).
measure: Thyroid Stimulating Hormone (TSH)
timeFrame: 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).
measure: Interferon-gamma (IFN-γ)
timeFrame: 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).
measure: Interferon-gamma (IFN-γ)
timeFrame: 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).
measure: Cognitive Function
timeFrame: 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).
measure: Cognitive Function
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).
measure: Neurofilament Light Chain (NFL)
timeFrame: 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).
measure: Neurofilament Light Chain (NFL)
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).
measure: Physical Self-Perception (PSP)
timeFrame: 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).
measure: Pain Catastrophizing Scale (PCS)
timeFrame: 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).
measure: Quality of Life questionnaire (MSQOL-54)
timeFrame: 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).
measure: State-Trait Anxiety (STAI)
timeFrame: 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).
measure: Rate of force development
timeFrame: 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).
measure: Rate of force development
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).
measure: Maximum Voluntary Isometric Contraction
timeFrame: 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).
measure: Maximum Voluntary Isometric Contraction
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).
measure: Maximal neural drive
timeFrame: 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).
measure: Maximal neural drive
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).
measure: Central activation ratio
timeFrame: 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).
measure: Central activation ratio
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).
measure: Upper Limb Maximum Strength
timeFrame: 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).
measure: Upper Limb Maximum Strength
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).
measure: Spasticity
timeFrame: 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).
measure: Spasticity
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).
measure: Intrinsic muscle characteristics: Tone (F)
timeFrame: 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).
measure: Intrinsic muscle characteristics: Tone (F)
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).
measure: Gait speed
timeFrame: 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).
measure: Gait speed
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).
measure: Static balance with eyes open
timeFrame: 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).
measure: Static balance with eyes open
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).
measure: Static balance with eyes closed
timeFrame: 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).
measure: Static balance with eyes closed
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).
measure: Sit-to-stand
timeFrame: 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).
measure: Sit-to-stand
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).
measure: Timed Up-and-Go test
timeFrame: 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).
measure: Timed Up-and-Go test
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).
measure: Delayed onset muscle soreness
timeFrame: 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).
measure: Delayed onset muscle soreness
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).
measure: Delayed onset muscle soreness
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).
measure: Delayed onset muscle soreness
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).
measure: Delayed onset muscle soreness
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).
measure: Subjective Perception of Effort (RPE)
timeFrame: 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).
measure: Subjective Perception of Effort
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).
measure: Subjective Perception of Effort
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).
measure: Subjective Perception of Effort
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).
measure: Fatigue Visual Analog Scale (VAS-F)
timeFrame: 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).
measure: Visual Analogue Scale for Fatigue (VAS-F)
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).
measure: Fatigue Visual Analog Scale (VAS-F)
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).
measure: Fatigue Visual Analog Scale (VAS-F)
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).
measure: Fatigue Visual Analog Scale (VAS-F)
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).
measure: Body Weight
timeFrame: 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).
measure: Physical Activity Level assessed by the International Physical Activity Questionnaire (IPAQ)
timeFrame: 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).
measure: Adherence to the Mediterranean Diet assessed by MEDAS
timeFrame: Baseline (pre-intervention)
measure: Adherence to the Mediterranean Diet assessed by MEDAS
timeFrame: Post-intervention (48 hours after the last session)
measure: The Kurtzke Disability Scale
timeFrame: Baseline (pre-intervention).
measure: The Kurtzke Disability Scale
timeFrame: Post-intervention (48 hours after the last session).
measure: Subjective Sleep Quality Questionnaire
timeFrame: 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).
measure: Subjective Sleep Quality Questionnaire
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).
measure: Subjective Sleep Quality Questionnaire
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).
measure: Subjective Sleep Quality Questionnaire
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).
measure: Subjective Sleep Quality Questionnaire
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).
measure: Sleep Quality Measured by Actigraph
timeFrame: 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).
measure: Sleep Quality Measured by Actigraph
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).
measure: Sleep Quality Measured by Actigraph
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).
measure: Sleep Quality Measured by Actigraph
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).
measure: Sleep Quality Measured by Actigraph
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).
measure: Progesterone (PG)
timeFrame: 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).
measure: Luteinizing Hormone (LH)
timeFrame: 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).
measure: Follicle-Stimulating Hormone (FSH)
timeFrame: 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).
measure: Estradiol (E2)
timeFrame: 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).
measure: Testosterone (T)
timeFrame: 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).
measure: Interleukin-6 (IL-6)
timeFrame: 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).
measure: Interleukin-6 (IL-6)
timeFrame: 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).
measure: Tumor Necrosis Factor-alpha (TNF-α)
timeFrame: 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).
measure: Tumor Necrosis Factor-alpha (TNF-α)
timeFrame: 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).
measure: Interleukin-10 (IL-10)
timeFrame: 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).
measure: Interleukin-10 (IL-10)
timeFrame: 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).
measure: Transforming Growth Factor Beta 1 (TGF-β1)
timeFrame: 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).
measure: Transforming Growth Factor Beta 1 (TGF-β1)
timeFrame: 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).
measure: Intrinsic muscle characteristics: Stiffness (S)
timeFrame: 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).
measure: Intrinsic muscle characteristics: Stiffness (S)
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).
measure: Intrinsic muscle characteristics: Elasticity (D)
timeFrame: 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).
measure: Intrinsic muscle characteristics: Elasticity (D)
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).
measure: Intrinsic muscle characteristics: Relaxation (R)
timeFrame: 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).
measure: Intrinsic muscle characteristics: Relaxation (R)
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).
measure: Intrinsic muscle characteristics: Creep (C)
timeFrame: 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).
measure: Intrinsic muscle characteristics: Creep (C)
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).
measure: Height
timeFrame: 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).
measure: Body Mass Index (BMI)
timeFrame: 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).
measure: Physical Activity Level assessed by Triaxial Accelerometer
timeFrame: 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).
measure: Nutrient Intake assessed by 3-Day Food Diary
timeFrame: Baseline (pre-intervention)
measure: Nutrient Intake assessed by 3-Day Food Diary
timeFrame: Post-intervention (48 hours after the last session)
measure: Lean Mass (%)
timeFrame: 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).
measure: Lean Mass (kg)
timeFrame: 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).
measure: Bone Mineral Content (BMC)
timeFrame: 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).
measure: Bone Mineral Density (BMD)
timeFrame: 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).
measure: Body Water
timeFrame: 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).
measure: Phase Angle
timeFrame: 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).
measure: Heart rate variability
timeFrame: 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).
measure: Heart rate variability
timeFrame: 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).
measure: Heart rate variability
timeFrame: 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).
measure: Heart rate variability
timeFrame: 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).
measure: Fat Mass (kg)
timeFrame: 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).
measure: Fat Mass (%)
timeFrame: 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).
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca
Study officials:
References: