Introduction Paediatric chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME) is a relatively common and disabling yet there is a limited evidence base for treatment. There is good evidence that Graded Exercise Therapy (GET) is moderately effective in adults with CFS/ME but there is no evidence for the effectiveness, cost effectiveness, acceptability or best method of delivery for paediatric CFS/ME.
This study aims to investigate the acceptability and feasibility of a carrying out a multi-centre randomised control trial (RCT) investigating the effectiveness of GET compared with activity management for mildly and moderately affected children.
Methods and analysis 100 paediatric patients (8–17 years) with CFS/ ME will be recruited from three UK specialist NHS CFS/ME services (Bath, Cambridge and Newcastle). Patients will be randomised (1:1) to receive either Graded exercise Therapy (GET) or Activity Management (AM). Feasibility analysis will include: the number of young person’s eligible, approached and consented to the trial; attrition rate and treatment compliance; questionnaire and accelerometer completion rates. Integrated qualitative methods will ascertain perceptions of feasibility and acceptability of recruitment, randomisation and the intervention. All Adverse events (SAE/AEs) will be monitored to assess the safety of the trial.
Ethics and dissemination The trial has received ethical approval from the National Research Ethics Service Committee NRES Committee South West – Frenchay (15/SW/0124).
Trial registration number ISRCTN23962803
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