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.
The trial has received ethical approval from the National Research Ethics Service (South West-Frenchay 15/SW/0124).
ISRCTN23962803; Pre-results.
100名患有CFS/ME的儿科患者(8-17岁)将从英国国家卫生服务(NHS)CFS/ME服务(Bath,剑桥和纽卡斯尔)。患者将被随机(1:1)接受分级运动疗法或活动管理。可行性分析将包括符合资格的青少年人数,接近并同意试验;流失率和治疗依从性;问卷和加速度计完成率。综合的定性方法将确定对招聘的可行性和可接受性的看法,随机化和干预措施。将监测所有不良事件以评估试验的安全性。
该试验已获得国家研究伦理服务(SouthWest-Frenchay15/SW/0124)的伦理批准。
ISRCTN23962803;预结果。