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) (ADVICE Phase 2)

Universidad de Almeria

Status: Active, not recruiting

Conditions: Multiple Sclerosis (MS) - Relapsing-remitting

Treatments: Other: Self-Guided and Unsupervised Program with General Recommendations; Other: Strength training, nutrition, and behavioral training

Study type: Interventional

Funder types: Other

Identifiers

NCT06884579

PID2021-123447OA-I00 (Other Identifier)

2024-3-15-HCUVA

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Supervised Strength Training Program (PE1)

Experimental group

Description:

Participants will complete 36 strength sessions (3 times a week) at a moderate intensity, 6 educational nutritional intervention sessions, and 8 sessions on energy and fatigue management.

Treatment:

Other: Strength training, nutrition, and behavioral training

Self-Guided and Unsupervised Program with General Recommendations (PE1)

Active Comparator group

Description:

Participants will be involved in an unsupervised, self-directed program focusing on physical exercise (three times per week), nutrition and cognitive-behavioral habits.

Treatment:

Other: Self-Guided and Unsupervised Program with General Recommendations