NCT05323838

Influence of Co-diagnosis of Chronic Fatigue Syndrome in Patients With Fibromyalgia.

Influence of Co-diagnosis of Chronic Fatigue Syndrome in Patients With Fibromyalgia on Physical Activity, Quality of Life and Immunoneuroendocrine Response.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 140 (estimated)
• Sponsor: University of Extremadura · Academic / Other
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate differences in neuroimmunoendocrine response and quality of live in patients diagnosed with Fibromyalgia, with or without a co-diagnosis of Chronic Fatigue Syndrome.

Detailed description

The limited literature published in concordant relation affects the chronic fatigue syndrome comorbidity in the daily life of fibromyalgia patients leads us to design this study with the main objective of evaluating differences in the quality of life associated with pain and stress, mainly in relation to levels of physical activity, sedentary lifestyle and sleep in patients diagnosed with fibromyalgia, with or without a parallel co-diagnosis of chronic fatigue syndrome.

Conditions

• Fibromyalgia
• Chronic Fatigue Syndrome
• Comorbidities and Coexisting Conditions

Interventions

Type	Name	Description
BEHAVIORAL	Subjective quality of live	The groups fill out scientifically validated questionnaires to know the differences in perceived stress, anxiety, quality of life, depression, quality of sleep, pain, fatigue, and impact of the disease on daily life.
PROCEDURE	Blood extraction	Blood collection by qualified personnel.
BEHAVIORAL	Accelerometry	To know the objective differences between physical activity/sedentary lifestyle, caloric expenditure and quality of sleep, we used the accelerometry technique
DIETARY_SUPPLEMENT	Synbiotic complement	On two separate days, the "baseline-tests" and "final-tests" were conducted. All participants performed a series of tests, before which they had to fast. The order and schedule (8 am) of the tests was the same for the "final-test" and the same materials and procedures were used. A period of 30 consecutive days elapsed between the base-line and final tests, during which the participants had to ingest their supplement (synbiotic).

Timeline

• Start date: 2021-06-09
• Primary completion: 2021-06-22
• Completion: 2024-11-16
• First posted: 2022-04-12
• Last updated: 2023-05-11

Locations

1 site across 1 country: Spain