Educational Programs Based on Healthy Habits to Improve Quality of Life and Psychosocial Profile … (NCT06884579) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
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)
Spain60 participantsStarted 2025-04-15
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Satisfaction with Physical Activity
Timeframe: Baseline (pre-intervention)
2
Satisfaction with Physical Activity
Timeframe: Immediately after the intervention
3
Visual Analogue Scale for Fatigue (VAS-F)
Timeframe: Immediately before each of the 36 exercise sessions (pre-session assessment).
4
Visual Analogue Scale for Fatigue (VAS-F)
Timeframe: Immediately after each of the 36 exercise sessions (post-session assessment).
5
Modified Fatigue Impact Scale (MFIS)
Timeframe: Baseline (pre-intervention).
6
Modified Fatigue Impact Scale (MFIS)
Timeframe: 48 hours after the last exercise session (post-intervention assessment).