OBJECTIVE: To propose a rehabilitation protocol able to produce immediate and long-term beneficial effects on level of disability and overall performance in ADLs. MATERIALS AND METHODS: Forty-one FM patients were randomized to an exercise and educational-behavioral programme group (experimental group, EG = 21) or to a control group (CG = 20). Each subject was evaluated before, at the end (T1), and after 6 months (T6) from the conclusion of the rehabilitation treatment using the Fibromyalgia Impact Questionnaire (FIQ), the visual analogue scale (VAS), the Health Assessment Questionnaire (HAQ), the fatigue severity scale (FSS), the 6-minute walking test (6MWT), tender points count (TPC), and spinal active range of motion. The exercise protocol included 20 sessions consisting in self-awareness, stretching, strengthening, spine flexibility, and aerobic exercises, which patients were subsequently educated to perform at home. RESULTS: The two groups were comparable at baseline. At T1, the EG showed a positive trend in FIQ, VAS, HAQ, and FSS scales and significant improvement in 6MWT and in most spinal active range of motion measurements (p between 0.001 and 0.04). The positive results were maintained at the follow-up. CONCLUSION: The proposed programme was well tolerated and produced immediate and medium-term beneficial effects improving function and strain endurance. This trial is registered with DRKS00005071 on DRKS.

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