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

NCT05719493 | Active Not Recruiting

• 1 other identifier: SLT/21/000009
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia; Chronic Fatigue Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

• change in quality of life

  to be evaluated with the EuroQol-5D questionnaire. It will be measured by a scale Likert: 0 (worst health) to 100 (better health) and a descriptive system with five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; with five levels of severity in each dimension: no problems, mild problems, moderate problems, severe problems, and extreme problems/impossibility.

  change from life quality at 1, 3, 6 and 12 months after the beginning of the intervention

Secondary Outcomes (15)

• change in fatigue indicator

  change from fatigue indicator at 1, 3, 6 and 12 months after the beginning of the intervention

• change in sleep quality and insomnia indicator

  change from sleep quality and insomnia indicator at 1, 3, 6 and 12 months after the beginning of the intervention

• change in pain indicator

  change from pain indicator at 1, 3, 6 and 12 months after the beginning of the intervention

• change in adherence to the Mediterranean diet

  change from adherence to the Mediterranean diet at 1, 3, 6 and 12 months after the beginning of the intervention

• change in physical exercise practice and sedentary lifestyle

  change from physical exercise practice and sedentary lifestyle at 1, 3, 6 and 12 months after the beginning of the intervention

Study Arms (2)

multicomponent-treatment no benefiting group

NO INTERVENTION

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

munticomponent-treatment benefiting group

EXPERIMENTAL

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

Other: multicomponent treatment

Interventions

multicomponent treatment 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.

munticomponent-treatment benefiting group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• Institut Català de la Salut: collaborator

Study Sites (1)

Institut Català de la Salut

Tortosa, Tarragona, 43500, Spain

Location

MeSH Terms

Conditions

Fibromyalgia; Fatigue Syndrome, Chronic; Motor Activity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 9, 2023
• Study Start: October 4, 2021
• Primary Completion: May 31, 2024
• Study Completion: December 1, 2025
• Last Updated: December 18, 2024

Record last verified: 2024-12

Locations

ES (1)