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Children aged 8-17 years with mild\/moderate ME\/CFS and presenting to NHS specialist paediatric services were allocated at random to either individualised flexible treatment focussing on physical activity (GET, 123 participants) or on managing cognitive, school and social activity (AM, 118 participants) delivered by NHS therapists. The primary outcome was the self-reported short-form 36 physical function subscale (SF-36-PFS) after 6\u00a0months, with higher scores indicating better functioning. After 6\u00a0months, data were available for 201 (83%) participants who received a mean of 3.9 (GET) or 4.6 (AM) treatment sessions. Comparing participants with measured outcomes in their allocated groups, the mean SF-36-PFS score changed from 54.8 (standard deviation 23.7) to 55.7 (23.3) for GET and from 55.5 (23.1) to 57.7 (26.0) for AM giving an adjusted difference in means of\u2009\u22122.02 (95% confidence interval\u2009\u22127.75, 2.70). One hundred thirty-five participants completed the mean SF-36-PFS at 12\u00a0months, and whilst further improvement was observed, the difference between the study groups remained consistent with chance. The two study groups showed similar changes on most of the secondary outcome measures: Chalder Fatigue, Hospital Anxiety and Depression Scale: Depression, proportion of full-time school attended, a visual analogue pain scale, participant-rated change and accelerometer measured physical activity, whether at the 6-month or 12-month assessment. There was an isolated finding of some evidence of an improvement in anxiety in those allocated to GET, as measured by the Hospital Anxiety and Depression Scale at 6\u00a0months, with the 12-month assessment, and the Spence Children\u2019s Anxiety scale being aligned with that finding. There was weak evidence of a greater risk of deterioration with GET (27%) than with AM (17%; <jats:italic>p<\/jats:italic>\u2009=\u20090.069). At conventional UK cost per QALY thresholds, the probability that GET is more cost-effective than AM ranged from 18 to 21%. Whilst completion of the SF-36-PFS, Chalder Fatigue Scale and EQ-5D-Y was good at the 6-month assessment point, it was less satisfactory for other measures, and for all measures at the 12-month assessment.<\/jats:p><jats:p>\u00a0 <jats:italic>Conclusion<\/jats:italic>: There was no evidence that GET was more effective or cost-effective than AM in this setting, with very limited improvement in either study group evident by the 6-month or 12-month assessment points.<\/jats:p><jats:p>\u00a0 <jats:italic>Trial registration<\/jats:italic>: The study protocol was registered at <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.isrctn.com\">www.isrctn.com<\/jats:ext-link> (3rd September 2015; ISRCTN 23962803) before the start of enrolment to the initial feasibility phase.<\/jats:p><jats:p><jats:table-wrap><jats:table><jats:tbody>\n                    <jats:tr>\n                      <jats:td colspan=\"2\"><jats:bold>What is Known:<\/jats:bold><jats:italic>\u2022 Paediatric ME\/CFS is disabling with negative effects on physical and cognitive function, mood and quality of life. Although CBT improves fatigue, disability and school attendance, at least 37% of children and young people with ME\/CFS have not recovered 6 months after beginning treatment.<\/jats:italic><jats:italic>\u2022 Graded exercise therapy (delivered flexibly) and activity management are acceptable to children and adolescents with ME\/CFS; however, there is no evidence on effectiveness or cost-effectiveness.<\/jats:italic><\/jats:td>\n                    <\/jats:tr>\n                    <jats:tr>\n                      <jats:td colspan=\"2\"><jats:bold>What is New:<\/jats:bold><jats:italic>\u2022 Graded exercise therapy delivered in an out-patient setting is neither more effective nor more cost-effective than activity management for paediatric ME\/CFS.<\/jats:italic><jats:italic>\u2022Physical function did not improve greatly in either group over the 12 months in this pragmatic study conducted in the UK NHS<\/jats:italic><\/jats:td>\n                    <\/jats:tr>\n                  <\/jats:tbody><\/jats:table><\/jats:table-wrap><\/jats:p>","DOI":"10.1007\/s00431-024-05458-x","type":"journal-article","created":{"date-parts":[[2024,3,2]],"date-time":"2024-03-02T04:29:26Z","timestamp":1709353766000},"page":"2343-2351","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Graded exercise therapy compared to activity management for paediatric chronic fatigue syndrome\/myalgic encephalomyelitis: pragmatic randomized controlled trial"],"prefix":"10.1007","volume":"183","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1253-307X","authenticated-orcid":false,"given":"Daisy M.","family":"Gaunt","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7958-7881","authenticated-orcid":false,"given":"Amberly","family":"Brigden","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7724-6621","authenticated-orcid":false,"given":"Shaun R. 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The UK National Research Ethics Service Committee (South West\u2014Frenchay 15\/SW\/0124) approved the MAGENTA feasibility study and all protocol amendments (Appendix ).","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"All young people and their parents or carers completed paper or online study consent or assent forms as appropriate prior to their participation in the study.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"This report is independent research, and the views expressed in this publication of are those of the authors and not necessarily those of the UK National Institute for Health and Care Research, or the UK Department of Health & Social Care. The funder had no role in the collection, analysis, interpretation of data, writing of the report or the decision to submit the article for publication.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Disclaimer"}},{"value":"Whilst leading the MAGENTA study, EC ran the specialist CFS\/ME service at Royal United Hospital NHS Foundation Trust, had received one grant from MRC, multiple grants from the UK NIHR and was an unfunded medical advisor to the Sussex & Kent ME\/CFS Society. The other authors declare no competing interests.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}