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)
NCT ID: NCT06884579
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
60 participants
INTERVENTIONAL
2025-04-15
2026-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Supervised Strength Training Program (PE1)
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.
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.
Self-Guided and Unsupervised Program with General Recommendations (PE1)
Participants will be involved in an unsupervised, self-directed program focusing on physical exercise (three times per week), nutrition and cognitive-behavioral habits.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
50 Years
ALL
No
Sponsors
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Hospital Universitario Virgen de la Arrixaca
OTHER
Universidad de Almeria
OTHER
Responsible Party
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Jacobo Á. Rubio-Arias
Principal Investigator
Locations
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Hospital Universitario Virgen de la Arrixaca
Murcia, Murcia, Spain
Countries
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Other Identifiers
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2024-3-15-HCUVA
Identifier Type: -
Identifier Source: org_study_id
PID2021-123447OA-I00
Identifier Type: OTHER
Identifier Source: secondary_id