Assessment of the Functional Capacity of Patients with Fibromyalgia: Clinical Validity

Launched by UNIVERSITY RAMON LLULL · Feb 4, 2025

Keywords

ClinConnect Summary

This study in Barcelona is looking at how well a standard set of tests can measure how fibromyalgia affects daily function and the ability to work. About 160 adult women (ages 30–64) with fibromyalgia will be enrolled, plus a control group of healthy, sedentary women. The fibromyalgia group will be divided into four groups: those who are actively working, those on sick leave, those with officially recognized work disability, and the healthy control group. The tests include a six-minute walk test (to measure endurance), a handgrip strength test, and a quick “8-foot Up & Go” test (to assess balance and speed), along with questionnaires about symptoms and quality of life. Participants will also wear activity trackers for a week.

Participants can expect several in-person visits at the start (with about a week between sessions) and follow-up questionnaires at 6 and 12 months. This is an observational study, meaning no treatment is given as part of the study. The main goal is to see if the tests are reliable and valid for assessing function in fibromyalgia and how they relate to activity levels and psychosocial factors like mood and social life. Eligibility requires being a woman aged 30–64 with a fibromyalgia diagnosis, or being a matched, sedentary woman without fibromyalgia for the control group. Privacy is protected, and the study is being conducted at two sites in Barcelona, with results expected around 2026.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Women aged between 30 and 64 years old with a diagnosis of fibromyalgia made by a rheumatologist or family doctor following the ACR diagnostic criteria.
• • For the control group, women matched by age with no diagnosis of fibromyalgia and with a sedentary lifestyle will be included.
• • All participants must agree to be part of the study.
• Exclusion Criteria (for both case group and control group):
• • Illiteracy and/or lack of understanding of Spanish.
• • Severe psychiatric and/or psychological disorders, associated musculoskeletal diseases that could increase pain, such as uncontrolled endocrine disorders, autoimmune diseases, and/or other associated rheumatological or neurological conditions.
• • Additionally, patients who refuse to participate in the study or any condition that, in the investigator\'s judgment, would prevent proper adherence to the protocol will be excluded.