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)

Last updated: March 13, 2025
Sponsor: Universidad de Almeria
Overall Status: Active - Recruiting

Phase

N/A

Condition

Multiple Sclerosis

Memory Loss

Neurologic Disorders

Treatment

Self-Guided and Unsupervised Program with General Recommendations

Strength training, nutrition, and behavioral training

Clinical Study ID

NCT06884579
2024-3-15-HCUVA
PID2021-123447OA-I00
  • Ages 18-50
  • All Genders

Study 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

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.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Self-Guided and Unsupervised Program with General Recommendations
Phase:
Study Start date:
April 15, 2025
Estimated Completion Date:
July 30, 2025

Connect with a study center

  • Hospital Universitario Virgen de la Arrixaca

    Murcia, 30120
    Spain

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.