MAGENTA trial

The MAGENTA trial (short for Managed Activity Graded Exercise in Teenagers and Pre-Adolescents) was a trial investigating the effectiveness and value for money of graded exercise therapy (GET) in children compared to "activity management".

Research team

 * Dr. Esther Crawley, Chief Investigator
 * Amberly Brigden, Trial Manager
 * Lucy Beasant, Research Associate

Protocol
The protocol of the trial was published in BMJ Open in July 2016.

Feasibility study
MAGENTA feasibility study (an assessment of the feasibility and acceptability of a full trial) ran from September 2015 to August 2016 with a planned sample size of 100. The results were expected to be published in 2017. Dr. David Tuller wrote a Trial By Error piece So What’s Happening with the MAGENTA Trial? Dr. Tuller noted the MAGENTA feasibility study was being folded into the larger sample."They were thus able to prioritize outcome measures based on actual data from the trial sample—an excellent way to bias the reported findings. In this case, the investigators designated physical function at six months as the primary outcome measure after almost half the full study sample had already provided data."The trial is expected to finish some time in 2019.

Funding
The trial was funded in full by the National Institute for Health Research.

Criticism
The trial has been criticized on several points.
 * It makes no use of objective outcome measures, instead opting to interview children and parents "in order to judge how well the treatment is working".
 * It told potential participants that there were no risks in participating in the trial, although there is evidence that GET may cause harm to patients.
 * The feasibility for the trial is based on the PACE trial, the results of which are contested.

There have been petitions to stop MAGENTA and other trials of GET until a safety review has been undertaken and the evidence reassessed.

James Coyne has urged parents not to enroll their children in the trial. He has highlighted the lack of information given to patients about potential harm, the consent procedure and the lack of published data on previous studies.

Research publications

 * Managed Activity Graded Exercise iN Teenagers and pre-Adolescents (MAGENTA) feasibility randomised controlled trial: study protocol (Full text)