Educational Programs Based on Healthy Habits to Improve Quality of Lif

Educational Programs Based on Healthy Habits to Improve Quality of Life and Psychosocial Profile in Women With Neurodegenerative Diseases: The ADVICE Protocol Study

CompletedNot a drug-phase studyRelapsing MSNCT06884579

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Strength training, nutrition, and behavioral training

Compared with

  • Self-Guided and Unsupervised Program with General Recommendations

What it measured

Main measures

  • Satisfaction with Physical Activity

    Baseline (pre-intervention)

    Physical functionQuality of life (reported by participants)

  • Satisfaction with Physical Activity

    Immediately after the intervention

    Physical functionQuality of life (reported by participants)

  • Visual Analogue Scale for Fatigue (VAS-F)

    Immediately before each of the 36 exercise sessions (pre-session assessment).

    Fatigue

  • Visual Analogue Scale for Fatigue (VAS-F)

    Immediately after each of the 36 exercise sessions (post-session assessment).

    Fatigue

  • Modified Fatigue Impact Scale (MFIS)

    Baseline (pre-intervention).

    Thinking and memoryFatigue

  • Modified Fatigue Impact Scale (MFIS)

    48 hours after the last exercise session (post-intervention assessment).

    Thinking and memoryFatigue

Other measures (61)

  • Inflammatory Profile

    Baseline (pre-intervention).

    Immune response

  • Inflammatory Profile

    48 hours after the last exercise session (post-intervention assessment).

    Immune response

  • The hormonal profile

    Pre-intervention in each phase of the menstrual cycle (early follicular phase, late follicular phase and mid-luteal phase).

    Walking and mobility

  • Cognitive Function

    Baseline (pre-intervention).

    Blood or spinal fluid markersThinking and memory

  • Cognitive Function

    48 hours after the last exercise session (post-intervention assessment).

    Blood or spinal fluid markersThinking and memory

  • Neurofilament Light Chain (NFL)

    Baseline (pre-intervention).

    Blood or spinal fluid markers

  • Neurofilament Light Chain (NFL)

    48 hours after the last exercise session (post-intervention assessment).

    Blood or spinal fluid markers

  • Physical Self-Perception

    Baseline (pre-intervention).

    Physical function

  • Physical Self-Perception

    48 hours after the last exercise session (post-intervention assessment).

    Physical function

  • Walking Endurance

    Baseline (pre-intervention).

    Walking and mobility

Who could take part

Relapsing MS · 18 to 50

Show the full criteria

Inclusion 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.

Exclusion criteria

Not separately supplied in the registry.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

Loading reviews and guidelines…

History

    1. Started

      Apr 2025

    2. Main results due

      Jun 2025

    3. Finished

      Jul 2026

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