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Managed Activity Graded Exercise iN Teenagers and pre-Adolescents (MAGENTA) feasibility randomised controlled trial: study protocol
  1. Amberly Brigden1,
  2. Lucy Beasant1,
  3. William Hollingworth1,
  4. Chris Metcalfe2,
  5. Daisy Gaunt2,
  6. Nicola Mills1,
  7. Russell Jago3,
  8. Esther Crawley1
  1. 1School of Social and Community Medicine, University of Bristol, Bristol, UK
  2. 2Bristol Randomised Trials Collaboration & School of Social and Community Medicine, University of Bristol, Bristol, UK
  3. 3Centre for Exercise, Nutrition & Health Sciences, School for Policy Studies, Bristol, UK
  1. Correspondence to Dr Esther Crawley; Esther.crawley{at}bristol.ac.uk

Abstract

Introduction 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.

Methods and analysis 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.

Ethics and dissemination The trial has received ethical approval from the National Research Ethics Service (South West—Frenchay 15/SW/0124).

Trial registration number ISRCTN23962803; Pre-results.

  • PAEDIATRICS
  • chronic fatigue syndrome
  • CFS/ME
  • ME
  • GET

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

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