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Abstract：
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.
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 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.
摘要：
小儿慢性疲劳综合征或肌痛性脑脊髓炎（CFS/ME）是一种相对常见且致残的疾病，然而，治疗的证据基础有限。有很好的证据表明，分级运动疗法对CFS/ME的成年人中等有效，但是几乎没有证据证明其有效性，成本效益，儿科CFS/ME的可接受性或最佳分娩方法。这项研究旨在调查进行多中心随机对照试验的可接受性和可行性，研究分级运动疗法与活动管理对轻度或中度受CFS/ME影响的儿童/青少年的有效性。
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。
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。
