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Graded Exercise Therapy guided Self-hElp Treatment (GETSET) for patients with chronic fatigue syndrome: a randomised controlled trial in secondary care
L.V. Clarka, P. McCroneb, D. Ridgec, A. Cheshirec, M. Vergara-Williamsond, F. Pesolaa, P.D. Whitea
aBarts and the London School of Medicine and Dentistry, Queen Mary University, UK
bHealth Services and Population Research, Kings College London, UK
cFaculty of Science and Technology, University of Westminster, UK
dKent & Medway NHS and Social Care Partnership Trust, UK
Background:
Previous trial findings show that graded exercise therapy (GET) can be an effective treatment for chronic fatigue syndrome, but therapy is expensive and requires attendance at hospital. This trial aimed to assess the efficacy and safety of Guided Exercise Self-help (GES).
Method:
In our randomised and controlled trial, patients meeting NICE criteria for chronic fatigue syndrome were recruited from two secondary care clinics in the UK and randomly allocated by computer-generated sequence to receive specialist medical care (SMC) alone or SMC supplemented with guided exercise self-help (GES). Primary outcomes were fatigue (Chalder fatigue questionnaire; CFQ) and physical function (short form-36 subscale score; SF-36) 12 weeks after randomisation, and safety was also assessed.
Primary outcomes were rated by participants, who were necessarily unmasked to assignment; the statistician was masked to treatment arm assignment for the analysis. We analysed unadjusted outcomes and also used linear regression to adjust for baseline values. The analysis was based on intention to treat.
Results:
We recruited 211 eligible patients (97% of target), of whom 107 were allocated to GES and 104 to SMC alone. At 12-weeks the GES group scored 4.1 (95% CI: 2.2 to 6.0) points lower on the CFQ and 6.3 (95% CI: 1.7 to 10.8) higher on the SF-36 compared to the SMC group (p < 0.001; p = 0.007) (adjusted model). Effect sizes were 0.5 and 0.2 respectively. Subgroup analysis of 141 participants meeting CDC criteria for CFS and 159 meeting Oxford criteria for CFS yielded equivalent results. Serious adverse events were recorded in 1 (1%) of the 107 GES group and 2 (2%) of the 104 SMC alone group.
Conclusion: Guided exercise self-help is a moderately effective and safe intervention for symptomatic relief of fatigue. Its effectiveness in increasing physical functioning is also significant but smaller.