Randomised controlled trial of patient education to encourage graded exercise in chronic fatigue syndrome

Objective To assess the efficacy of an educational intervention explaining symptoms to encourage graded exercise in patients with chronic fatigue synd rome Design Randomised controlled trial. Setting Chromic fatigue clinic and infectious diseases outpatient clinic. Subjects 148 consecutively referred patients fulfilling Oxford criteria for chronic fatigue syndrome. Interventions Patients randomised to the control group received standardise d medical care. Patients randomised to intervention received two individual treatment sessions and two telephone follow up calls, supported by a compr ehensive educational pack, describing the role of disrupted physiological r egulation in fatigue symptoms and encouraging home based graded exercise. T he minimum intervention group had no further treatment, but the telephone i ntervention group received am additional seven follow up calls and the maxi mum intervention group an additional seven face to face sessions over four months. Main outcome measure A score of greater than or equal to 25 or an increase of greater than or equal to 10 on the SF-36 physical functioning subscale ( range 10 to 30) 12 months after randomisation. Results 21 patients dropped out, mainly from the intervention groups. Inten tion to treat analysis showed 79 (69%) of patients in the intervention grou ps achieved a satisfactory outcome in physical functioning compared with tw o (6%) of controls, who received standardised medical care (P < 0.0001). Si milar improvements were observed in fatigue, sleep, disability, and mood. N o significant differences were found between the three intervention groups. Conclusions Treatment incorporating evidence based physiological explanatio ns for symptoms was effective in encouraging self managed graded exercise. This resulted in substantial improvement compared with standardised medical care.