From BMJ Open, 4 July 2016.
Managed Activity Graded Exercise iN Teenagers and pre-Adolescents (MAGENTA) feasibility randomised controlled trial: study protocol
Amberly Brigden(1), Lucy Beasant(1), William Hollingworth(1), Chris Metcalfe(2), Daisy Gaunt(2), Nicola Mills(1), Russell Jago(3), Esther Crawley(1)
1) School of Social and Community Medicine, University of Bristol, Bristol, UK
2) Bristol Randomised Trials Collaboration & School of Social and Community Medicine, University of Bristol, Bristol, UK
3) Centre for Exercise, Nutrition & Health Sciences, School for Policy Studies, Bristol, UK
Dr Esther Crawley; Esther.email@example.com
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.
Strengths and limitations of this study
* This feasibility study is the first trial to investigate graded exercise therapy in children with chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME) in the outpatient setting.
* Integrated qualitative methodology is being used to optimise recruitment and retention, and to investigate the feasibility and acceptability of the study processes and interventions.
* This is a multicentre study which will test the feasibility of running this trial in different National Health Service (NHS) settings.
* The participants and clinicians will not be blinded to allocation.
* Participant outcomes are self-reported.