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Effectiveness and Health Benefits of a Nutritional, Chronobiological and Physical Exercise Intervention in Fibromyalgia and Chronic Fatigue Syndrome (SYNCHRONIZE +)

NCT ID: NCT05719493

Last Updated: 2024-12-18

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-04

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Fibromyalgia Chronic Fatigue Syndrome

Keywords

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multicomponent intervention nutrition chronobiology physical exercise quality of life primary health care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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multicomponent-treatment no benefiting group

Participants in the control group will receive the care from the usual clinical practice

Group Type NO_INTERVENTION

No interventions assigned to this group

munticomponent-treatment benefiting group

Partcipants in the intervention group will receive the care from the usual practice plus the studied intervention.

Group Type EXPERIMENTAL

multicomponent treatment

Intervention Type OTHER

The intervention to be evaluated consists of 4 group sessions carried out in two weeks, 6 hours per week divided in 2 days (a total of 12 hours), of active education in nutrition, chronobiology and physical exercise in people diagnosed with Chronic Fatigue Syndrome and Fibromyalgia.

Interventions

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multicomponent treatment

The intervention to be evaluated consists of 4 group sessions carried out in two weeks, 6 hours per week divided in 2 days (a total of 12 hours), of active education in nutrition, chronobiology and physical exercise in people diagnosed with Chronic Fatigue Syndrome and Fibromyalgia.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Català de la Salut

OTHER

Sponsor Role collaborator

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut Català de la Salut

Tortosa, Tarragona, Spain

Site Status

Countries

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Spain

Other Identifiers

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SLT/21/000009

Identifier Type: -

Identifier Source: org_study_id