Effectiveness and Health Benefits of a Nutritional, Chronobiological and Physical Exercise Interv… (NCT05719493) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effectiveness and Health Benefits of a Nutritional, Chronobiological and Physical Exercise Intervention in Fibromyalgia and Chronic Fatigue Syndrome (SYNCHRONIZE +)
Spain86 participantsStarted 2021-10-04
Plain-language summary
Chronic pain, fatigue and insomnia are classical symptoms of Fibromyalgia and Chronic Fatigue Syndrome, affecting seriously life quality. Non-pharmacological multicomponent approach is gaining relevance in Fibromyalgia treatment. However, nutrition and chronobiology are often not approached in-depth despite their potential. Furthermore, programs addressed to Chronic Fatigue Syndrome are still scare. This study aims to evaluate the effectiveness of a compact multidisciplinary group intervention based on nutrition, chronobiology and physical exercise in the improvement of lifestyle and life quality in Fibromyalgia and Chronic Fatigue syndrome.
Who can participate
Age range
18 Years – 65 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:
* People aged 18-65, recent diagnosis of Fibromyalgia (M79.1) (\<10 years), or diagnosis of Fibromyalgia and Chronic Fatigue Syndrome (M79 .7 and G93.3), with availability, motivation and interest in the intervention.
Exclusion Criteria:
* not meeting the inclusion criteria, being participating in other group interventions aimed at the treatment of these syndromes, presence of severe mental comorbidity or other relevant medical disorders or pathologies that may interfere with the evaluation of the intervention
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
change in quality of life
Timeframe: change from life quality at 1, 3, 6 and 12 months after the beginning of the intervention
Trial details
NCT IDNCT05719493
SponsorFundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina