OBJECTIVE: To assess the impact of a long-term exercise programme vs usual care on perceived health status, functional capacity and depression in patients with fibromyalgia. DESIGN: Randomized controlled trial.SUBJECTS: Forty-two women with fibromyalgia were allocated randomly to 1 of 2 groups: an experimental group that carried out aerobic, strength and flexibility exercises for 24 weeks and a usual care control group.METHODS: Health status and functional capacity were evaluated using the Fibromyalgia Impact Questionnaire and the Short Form Health Survey 36. Depression was evaluated with the Beck Depression Inventory.RESULTS: Significant improvements were observed in health status and functional capacity for the exercise group over the control group. The magnitude of the effect size of these improvements, expressed as Cohen's d, was medium. The effect size (95% confidence interval) for the Fibromyalgia Impact Questionnaire was 0.58 (-14.12, -2.35), for the Short Form Health Survey 36. global score 0.54 (1.28, 14.52), and in the mental health domain of the Short Form Health Survey 36. 0.51 (1.20, 16.26). There was a large effect size in vitality. All the aforementioned improvements can be considered as clinically important changes.CONCLUSION: Results confirm that a long-term combination of aerobic exercise, strengthening and flexibility improves psychological health status and health-related quality of life in patients with fibromyalgia.