title: Managed Activity Graded Exercise iN Teenagers and pre-Adolescents (MAGENTA) feasibility randomised controlled trial: study protocol.
abstract: Paediatric chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME) is a relatively common and disabling condition, yet there is a limited evidence base for treatment. There is good evidence that graded exercise therapy is moderately effective in adults with CFS/ME, but there is little 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 carrying out a multicentre randomised controlled trial investigating the effectiveness of graded exercise therapy compared with activity management for children/teenagers who are mildly or moderately affected with CFS/ME.
  
  
  
  100 paediatric patients (8-17 years) with CFS/ME will be recruited from 3 specialist UK National Health Service (NHS) CFS/ME services (Bath, Cambridge and Newcastle). Patients will be randomised (1:1) to receive either graded exercise therapy or activity management. Feasibility analysis will include the number of young people eligible, approached and consented to the trial; attrition rate and treatment adherence; questionnaire and accelerometer completion rates. Integrated qualitative methods will ascertain perceptions of feasibility and acceptability of recruitment, randomisation and the interventions. All adverse events will be monitored to assess the safety of the trial.
  
  
  
  The trial has received ethical approval from the National Research Ethics Service (South West-Frenchay 15/SW/0124).
  
  
  
  ISRCTN23962803; Pre-results.
authors.affiliation: School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors.forename: Amberly
authors.initials: A
authors.lastname: Brigden
authors.affiliation: School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors.forename: Lucy
authors.initials: L
authors.lastname: Beasant
authors.affiliation: School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors.forename: William
authors.initials: W
authors.lastname: Hollingworth
authors.affiliation: Bristol Randomised Trials Collaboration & School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors.forename: Chris
authors.initials: C
authors.lastname: Metcalfe
authors.affiliation: Bristol Randomised Trials Collaboration & School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors.forename: Daisy
authors.initials: D
authors.lastname: Gaunt
authors.affiliation: School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors.forename: Nicola
authors.initials: N
authors.lastname: Mills
authors.affiliation: Centre for Exercise, Nutrition & Health Sciences, School for Policy Studies, Bristol, UK.
authors.forename: Russell
authors.initials: R
authors.lastname: Jago
authors.affiliation: School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors.forename: Esther
authors.initials: E
authors.lastname: Crawley
mesh_terms: D000293:Adolescent; D002648:Child; D003362:Cost-Benefit Analysis; D005081:Exercise Therapy; D005221:Fatigue / Q000628:therapy; D015673:Fatigue Syndrome, Chronic / Q000628:therapy*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D010342:Patient Acceptance of Health Care; D010372:Pediatrics; D012107:Research Design; D011795:Surveys and Questionnaires
keywords: CFS/ME; GET; ME; PAEDIATRICS; chronic fatigue syndrome