Randomised controlled trial of graded exercise in patients with the chronic fatigue syndrome

Abstract Objective: To test the efficacy of a graded aerobic exercise programme in the chronic fatigue syndrome. Design: Randomised controlled trial with control treatment crossover after the first follow up examination. Setting: Chronic fatigue clinic in a general hospital department of psychiatry. Subjects: 66 patients with the chronic fatigue syndrome who had neither a psychiatric disorder nor appreciable sleep disturbance. Interventions: Random allocation to 12 weeks of either graded aerobic exercise or flexibility exercises and relaxation therapy. Patients who completed the flexibility programme were invited to cross over to the exercise programme afterwards. Main outcome measure: The self rated clinical global impression change score, “very much better” or “much better” being considered as clinically important. Results: Four patients receiving exercise and three receiving flexibility treatment dropped out before completion. 16 of 29 patients rated themselves as better after completing exercise treatment compared with eight of 30 patients who completed flexibility treatment. Analysis by intention to treat gave similar results (17/33 v 9/33 patients better). Fatigue, functional capacity, and fitness were significantly better after exercise than after flexibility treatment. 12 of 22 patients who crossed over to exercise after flexibility treatment rated themselves as better after completing exercise treatment. 32 of 47 patients rated themselves as better three months after completing supervised exercise treatment. 35 of 47 patients rated themselves as better one year after completing supervised exercise treatment. Conclusion: These findings support the use of appropriately prescribed graded aerobic exercise in the management of patients with the chronic fatigue syndrome. Key messages Graded exercise treatment is more effective than relaxation and flexibility treatment for patients with the chronic fatigue syndrome who do not have a psychiatric disorder or sleep disturbance Overall improvement is accompanied by improvements in fatigue and physical function but seems independent of the improved strength and peak aerobic capacity produced by exercise In this survey few patients refused or dropped out of exercise treatment and only one patient claimed to be worse after completing it Patients show sustained benefit one year after graded exercise treatment