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
Correspondence to
Dr Esther Crawley; Esther.crawley@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.
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.
It’s deeply worrying and a real heart sink moment to find that a woman who believes “ME is common and easily treatable” and is a proponent of the illness belief theory has been given ethical approval and funding for this study. To be given funding and approval for a study on GET when GET has been thoroughly rejected by patients and many physicians/researchers as unsafe and when it is also mired in the controversy surrounding refusal to release the PACE trial data seems utterly incomprehensible
There is so much evidence already that GET is unsuitable for use in ME. It also seems unethical to do this research on children especially when the results are to be based on self-report. Young children are not self-determining free agents and are very susceptible to suggestion and desire to please adults especially if those adults are claiming to provide something helpful to them. I know from my own experience as an adult with ME just how difficult it is to tell a consultant that the treatment given has not worked.
Esther Crawley believes “ME is common and easily treatable” these two statements ring alarm bells for anyone familiar with real Neuroimmune ME. Teenagers often have problems getting up in the morning but that is a far cry from ME so it is crucial that the criteria for diagnosing ME and not a behavioral disorder is stringent and does not include just children with fatigue for some other reason.
No ME patient or competent biomedical physician/researcher in ME would ever say that ME is easily treatable.
Esther seems to have a totally different concept of what constitutes ME to everyone else and that has to be a matter of great concern in regard to any research she does.
I totally agree with mayfly. This totally unwarranted study is a disgraceful waste of money which could be used on biomedical research, and it illustrates a gross and willful refusal to acknowledge the reams of good evidence which already exist.
No coincidence that Dr Nigel Speight has been gagged recently.
Jane Colby’s excellent recent speech at the House of Lords:
http://www.methenewplague.net/blog/2016/07/04/SPEECH-AT-HOUSE-OF-LORDS-2016.aspx