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G73(P) The MAGENTA protocol: The feasibility and acceptability of conducting a trial investigating the effectiveness and cost effectiveness of graded exercise therapy compared to activity management for paediatric CFS/ME – a feasibility randomised controlled trial
  1. AB Brigden1,
  2. LB Beasant1,
  3. WH Hollingworth1,
  4. CM Metcalfe1,
  5. DG Gaunt1,
  6. NM Mills1,
  7. RJ Jago2,
  8. EC Crawley1
  1. 1School of Social and Community Medicine, University of Bristol, Bristol, UK
  2. 2Centre for Exercise, Nutrition & Health Sciences, University of Bristol, Bristol, UK

Abstract

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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