Efficacy and mechanism of supervised adapted physical activity on quality of life for patients with fibromyalgia: single-center, prospective, randomised clinical and neuroimaging study.

Fibromyalgia (FM) is a chronic overlapping pain condition that impairs quality of life (QOL). Adapted physical activity (APA) is recommended as a key non-pharmacological intervention, though its implementation and underlying mechanisms remain limited. Fibromyactiv, a prospective, randomised, single-blind clinical and neuroimaging study, evaluated the efficacy and mechanisms of a structured, supervised APA program in FM. Seventy-nine adults were assigned to supervised APA (n = 39) or standard care (n = 40) and followed for 12 months. The intervention consisted of diversified, low-intensity, fractionated sessions three times weekly for 6 months. Outcomes included the Fibromyalgia Impact Questionnaire (FIQ, primary endpoint at M6), clinical and psychological scales, functional tests, pedometer monitoring, and mechanistic measures (¹⁸F-FDG PET, blood/urine biomarkers). Supervised APA produced significantly greater FIQ improvement and broader benefits across PGIC, Widespread Pain Index, Symptom Severity Scale, tender points, mean pain, sleep quality, flexibility, and daily step counts. Immediate symptom relief occurred after each session. Brain PET revealed increased metabolism in the right cerebellum in the APA group, correlating positively with step-count improvement. This interdisciplinary trial demonstrates that a reproducible supervised APA program yields sustained improvements in QOL, symptoms, and functional activity in FM, potentially mediated by cerebellar modulation of motor and behavioural engagement.ClinicalTrials.govIdentifier: NCT03640806 N°IDRCB:2017-A03011-52. Sponsor: Assistance Publique Hôpitaux De Marseille (Marseille Public Hospital System). Other Study ID Numbers: 2017-57.