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 | Active Not Recruiting

• 2 other identifiers: 2024-3-15-HCUVAPID2021-123447OA-I00
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis (MS) - Relapsing-remitting

Keywords

Relapsing-Remitting MS; Fatigue; Cognitive Behavioral Therapy; Physical exercise; Dietary habits; Women's Health

Outcome Measures

Primary Outcomes (6)

• Satisfaction with Physical Activity

  Satisfaction with Physical Activity will be measured using an eight-item, 5-point Likert scale

  Baseline (pre-intervention)

• Satisfaction with Physical Activity

  Satisfaction with Physical Activity will be measured using an eight-item, 5-point Likert scale

  Immediately after the intervention

• Visual Analogue Scale for Fatigue (VAS-F)

  The Visual Analogue Scale for Fatigue (VAS-F) assesses subjective levels of fatigue and energy

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

• Visual Analogue Scale for Fatigue (VAS-F)

  The Visual Analogue Scale for Fatigue (VAS-F) assesses subjective levels of fatigue and energy

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

• Modified Fatigue Impact Scale (MFIS)

  Fatigue perception will be measured using the MFIS. This scale is a 21-item multidimensional questionnaire that evaluates the physical, cognitive, and psychosocial effects of fatigue on a five-point ordinal scale (with a maximum total score of 84).

  Baseline (pre-intervention).

• Modified Fatigue Impact Scale (MFIS)

  Fatigue perception will be measured using the MFIS. This scale is a 21-item multidimensional questionnaire that evaluates the physical, cognitive, and psychosocial effects of fatigue on a five-point ordinal scale (with a maximum total score of 84)

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

Secondary Outcomes (61)

• Inflammatory Profile

  Baseline (pre-intervention).

• Inflammatory Profile

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

• The hormonal profile

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

• Cognitive Function

  Baseline (pre-intervention).

• Cognitive Function

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

Study Arms (2)

Supervised Strength Training Program (PE1)

EXPERIMENTAL

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.

Other: Strength training, nutrition, and behavioral training

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

ACTIVE COMPARATOR

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

Other: Self-Guided and Unsupervised Program with General Recommendations

Interventions

Strength training, nutrition, and behavioral training OTHER

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.

Supervised Strength Training Program (PE1)

Self-Guided and Unsupervised Program with General Recommendations OTHER

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.

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Almeria: lead
• Hospital Universitario Virgen de la Arrixaca: collaborator

Study Sites (1)

Hospital Universitario Virgen de la Arrixaca

Murcia, Murcia, 30120, Spain

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Fatigue; Motor Activity; Feeding Behavior

Interventions

Resistance Training; Nutritional Status

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Behavior, Animal

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: March 19, 2025
• Study Start: April 15, 2025
• Primary Completion: June 15, 2025
• Study Completion (Estimated): July 28, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

ES (1)