Clinical trial NCT05719493: Effectiveness and Health Benefits of a Nutritional, Chronobiological and Physical Exercise Intervention in Fibromyalgia and Chronic Fatigue Syndrome (SYNCHRONIZE +)
Official title: Effectiveness and Health Benefits of a Nutritional, Chronobiological and Physical Exercise Primary Care Intervention in Fibromyalgia and Chronic Fatigue Syndrome: SYNCHRONIZE + Mixed Methods Study Protocol.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Fibromyalgia
Chronic Fatigue Syndrome
Keywords: multicomponent intervention
nutrition
chronobiology
physical exercise
quality of life
primary health care
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Institut Català de la Salut
First posted: 2023-02-09
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: The investigators will perform a mixed study through a randomized clinical trial in Catalonian Primary Care with patients diagnosed of Fibromyalgia (M79.7) or both Fibromyalgia and Chronic Fatigue Syndrome (G93.3). The control group will follow the usual clinical practice and the intervention group, the usual practice plus the studied intervention (12 hours in 4 days). The intervention (based on nutrition, chronobiology and physical exercise) will be designed taking into account participant's opinion through focus groups. In both groups, quality of life (EuroQol-5D), as well as MFI, VAS pain, PSQI, erMEDAS-17, BRIAN, REGICOR-Short, FIQR and HADs questionnaires will be collected, prior to the intervention, and 1, 3, 6 and 12 months post-intervention. Food intake, body composition, resistance and strength will also be evaluated. The effect size will be calculated using Cohen's d and logistic regression models will be used to quantify the impact of the intervention by adjusting for different variables. In addition, a qualitative analysis with a descriptive phenomenological perspective from post-intervention focus groups of participants and professionals will be done.

Eligibility criteria: 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

Primary outcomes:
measure: change in quality of life
timeFrame: change from life quality at 1, 3, 6 and 12 months after the beginning of the intervention
Secondary outcomes:
measure: change in fatigue indicator
timeFrame: change from fatigue indicator at 1, 3, 6 and 12 months after the beginning of the intervention
measure: change in sleep quality and insomnia indicator
timeFrame: change from sleep quality and insomnia indicator at 1, 3, 6 and 12 months after the beginning of the intervention
measure: change in pain indicator
timeFrame: change from pain indicator at 1, 3, 6 and 12 months after the beginning of the intervention
measure: change in adherence to the Mediterranean diet
timeFrame: change from adherence to the Mediterranean diet at 1, 3, 6 and 12 months after the beginning of the intervention
measure: change in physical exercise practice and sedentary lifestyle
timeFrame: change from physical exercise practice and sedentary lifestyle at 1, 3, 6 and 12 months after the beginning of the intervention
measure: change in circadian biological rhythm
timeFrame: change from circadian biological rhythm at 1, 3, 6 and 12 months after the beginning of the intervention
measure: change in functional impact of fibromyalgia
timeFrame: change from functional impact of fibromyalgia at 1, 3, 6 and 12 months after the beginning of the intervention
measure: change in mood indicator (anxiety)
timeFrame: change from mood indicator (anxiety) at 1, 3, 6 and 12 months after the beginning of the intervention
measure: change in food intake
timeFrame: change from food intake at at 1, 3, 6 and 12 months after the beginning of the intervention
measure: change in body mass index (BMI)
timeFrame: change from BMI at 1, 3, 6 and 12 months after the beginning of the intervention
measure: change in body fat
timeFrame: change from body fat at 1, 3, 6 and 12 months after the beginning of the intervention
measure: change in skeletal muscle
timeFrame: change from skeletal muscle at 1, 3, 6 and 12 months after the beginning of the intervention
measure: change in endurance
timeFrame: change from endurance at 1, 3, 6 and 12 months after the beginning of the intervention
measure: change in lower body muscular strength
timeFrame: change from lower body muscular strength at 1, 3, 6 and 12 months after the beginning of the intervention
measure: change in upper body muscular strength
timeFrame: change from upper body muscular strength at at 1, 3, 6 and 12 months after the beginning of the intervention
Other outcomes:
Locations:
city: Tortosa
country: Spain
facility: Institut Català de la Salut
state: Tarragona
Study officials:
References: