Clinical trial NCT06884579: Educational Programs Based on Healthy Habits to Improve Quality of Life and Psychosocial Profile in Women With Neurodegenerative Diseases: the ADVICE Protocol Study (Phase 2)
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: Relapsing-Remitting MS
Fatigue
Cognitive Behavioral Therapy
Physical exercise
Dietary habits
Women&#39;s Health
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Virgen de la Arrixaca
First posted: 2025-03-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This phase of the project aims to compare in-person, supervised educational programs (EP) with online self-guided EPs in individuals with relapsing-remitting multiple sclerosis. A total of 75 participants will be randomly assigned to one of three groups: a supervised and individualized educational program focused on HIIT training, a supervised and individualized educational program focused on strength training, and a non-supervised, self-guided educational program based on resistance band training. Additionally, sessions on the Mediterranean diet (both supervised and non-supervised) and cognitive-behavioral interventions will be included. A control evaluation will be conducted three months after the intervention to assess the effects of the educational programs, followed by another evaluation three months later to analyze residual effects. Women who participated in Phase 1 of the study will be invited to take part in this second phase.


Eligibility criteria: Inclusion criteria include:

* Women and men of reproductive age (18-45 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: Baseline (pre-intervention)
measure: Satisfaction with Physical Activity
timeFrame: Immediately after the intervention
measure: Visual Analogue Scale for Fatigue (VAS-F)
timeFrame: Immediately before each of the 36 exercise sessions (pre-session assessment).
measure: Visual Analogue Scale for Fatigue (VAS-F)
timeFrame: Immediately after each of the 36 exercise sessions (post-session assessment).
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: Baseline (pre-intervention).
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: 48 hours after the last exercise session (post-intervention assessment).
Secondary outcomes:
measure: Inflammatory Profile
timeFrame: Baseline (pre-intervention).
measure: Inflammatory Profile
timeFrame: 48 hours after the last exercise session (post-intervention assessment).
measure: The hormonal profile
timeFrame: Pre-intervention in each phase of the menstrual cycle (early follicular phase, late follicular phase and mid-luteal phase).
measure: Cognitive Function
timeFrame: Baseline (pre-intervention).
measure: Cognitive Function
timeFrame: 48 hours after the last exercise session (post-intervention assessment).
measure: Neurofilament Light Chain (NFL)
timeFrame: Baseline (pre-intervention).
measure: Neurofilament Light Chain (NFL)
timeFrame: 48 hours after the last exercise session (post-intervention assessment).
measure: Physical Self-Perception
timeFrame: Baseline (pre-intervention).
measure: Physical Self-Perception
timeFrame: 48 hours after the last exercise session (post-intervention assessment).
measure: Walking Endurance
timeFrame: Baseline (pre-intervention).
measure: Walking Endurance
timeFrame: 48 hours after the last exercise session (post-intervention assessment).
measure: Pain Catastrophizing
timeFrame: Baseline (pre-intervention).
measure: Pain Catastrophizing
timeFrame: 48 hours after the last exercise session (post-intervention assessment).
measure: Quality of Life questionnaire
timeFrame: Baseline (pre-intervention).
measure: Quality of Life questionnaire
timeFrame: 48 hours after the last exercise session (post-intervention assessment).
measure: State-Trait Anxiety
timeFrame: Baseline (pre-intervention).
measure: State-Trait Anxiety
timeFrame: 48 hours after the last exercise session (post-intervention assessment).
measure: Rate of force development
timeFrame: Baseline (pre-intervention).
measure: Rate of force development
timeFrame: 48 hours after the last exercise session (post-intervention assessment).
measure: Maximum Voluntary Isometric Contraction
timeFrame: Baseline (pre-intervention).
measure: Maximum Voluntary Isometric Contraction
timeFrame: 48 hours after the last exercise session (post-intervention assessment).
measure: Maximal neural drive
timeFrame: Baseline (pre-intervention).
measure: Maximal neural drive
timeFrame: 48 hours after the last exercise session (post-intervention assessment).
measure: Central activation ratio
timeFrame: Baseline (pre-intervention).
measure: Central activation ratio
timeFrame: 48 hours after the last exercise session (post-intervention assessment).
measure: Upper Limb Maximum Strength
timeFrame: Baseline (pre-intervention).
measure: Upper Limb Maximum Strength
timeFrame: 48 hours after the last exercise session (post-intervention assessment).
measure: Spasticity
timeFrame: Before the first session of the intervention program
measure: Spasticity
timeFrame: 48 hours after the last exercise session (post-intervention assessment).
measure: Intrinsic muscle characteristics
timeFrame: Baseline (pre-intervention).
measure: Intrinsic muscle characteristics
timeFrame: 48 hours after the last exercise session (post-intervention assessment).
measure: Gait speed
timeFrame: Baseline (pre-intervention).
measure: Gait speed
timeFrame: 48 hours after the last exercise session (post-intervention assessment).
measure: Static balance with eyes open
timeFrame: Baseline (pre-intervention).
measure: Static balance with eyes open
timeFrame: 48 hours after the last exercise session (post-intervention assessment).
measure: Static balance with eyes closed
timeFrame: Baseline (pre-intervention).
measure: Static balance with eyes closed
timeFrame: 48 hours after the last exercise session (post-intervention assessment).
measure: Sit-to-stand
timeFrame: Baseline (pre-intervention).
measure: Sit-to-stand
timeFrame: 48 hours after the last exercise session (post-intervention assessment).
measure: Timed Up-and-Go test
timeFrame: Baseline (pre-intervention).
measure: Timed Up-and-Go test
timeFrame: 48 hours after the last exercise session (post-intervention assessment).
measure: Delayed onset muscle soreness
timeFrame: Baseline (pre-intervention).
measure: Subjective Perception of Effort
timeFrame: Baseline (pre-intervention).
measure: Fatigue Visual Analog Scale (VAS-F)
timeFrame: Baseline (pre-intervention).
measure: Anthropometric
timeFrame: Baseline (pre-intervention).
measure: Anthropometric
timeFrame: 48 hours after the last exercise session (post-intervention assessment).
measure: Bioimpedance
timeFrame: Baseline (pre-intervention).
measure: Bioimpedance
timeFrame: 48 hours after the last exercise session (post-intervention assessment).
measure: Physical Activity Levels
timeFrame: Baseline (pre-intervention).
measure: Physical Activity Levels
timeFrame: 48 hours after the last exercise session (post-intervention assessment).
measure: Dietary and Nutritional Follow-up
timeFrame: Baseline (pre-intervention).
measure: Dietary and Nutritional Follow-up
timeFrame: 48 hours after the last exercise session (post-intervention assessment).
measure: The Kurtzke Disability Scale
timeFrame: Baseline (pre-intervention).
measure: The Kurtzke Disability Scale
timeFrame: 48 hours after the last exercise session (post-intervention assessment).
measure: Subjective Sleep Quality Questionnaire
timeFrame: Baseline (pre-intervention).
measure: Subjective Sleep Quality Questionnaire
timeFrame: 48 hours after the last exercise session (post-intervention assessment).
measure: Sleep Quality Measured by Actigraph
timeFrame: The week prior to the start of the intervention. Baseline (pre-intervention).
measure: Sleep Quality Measured by Actigraph
timeFrame: The week following the completion of the intervention (post-intervention assessment).
measure: Delayed onset muscle soreness
timeFrame: Immediately after each physical exercise session (post-intervention assessment).
measure: Subjective Perception of Effort
timeFrame: Immediately after each physical exercise session (post-intervention assessment).
measure: Fatigue Visual Analog Scale (VAS-F)
timeFrame: Immediately after each physical exercise session (post-intervention assessment).
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca
Study officials:
References: