MedTrace Logo

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)

NCT06884579 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-03-24

No results posted yet for this 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.

Conditions

  • Multiple Sclerosis (MS) - Relapsing-remitting

Interventions

OTHER

Strength training, nutrition, and behavioral training

This arm of the study consists of a supervised strength training program, conducted over 12 weeks with three weekly sessions. The sessions follow a wave-like periodization, with intensities ranging from 70% to 85% of 1-RM. Exercises focus on enhancing neuromuscular strength in the lower limbs, such as leg presses and hip extensions, under the supervision of a multidisciplinary team. Participants will also receive nutritional guidance based on the Mediterranean diet, as well as cognitive-behavioral therapy strategies aimed at optimizing fatigue management and boosting energy levels.

OTHER

Self-Guided and Unsupervised Program with General Recommendations

This arm of the study consists of a self-guided and unsupervised program based on physical exercise (3 times per week), nutrition, and cognitive-behavioral habits. Participants will access online modules that provide guidelines for performing resistance exercises with bands, dietary recommendations following the principles of the Mediterranean diet, and cognitive-behavioral techniques for fatigue management.

Sponsors & Collaborators

  • Hospital Universitario Virgen de la Arrixaca

    collaborator OTHER

  • Universidad de Almeria

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-15
Primary Completion
2025-06-15
Completion
2026-07-28

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06884579 on ClinicalTrials.gov