Plain English Summary
Background and study aims
Chronic fatigue syndrome (CFS), also known as myalgic encephalomyelitis (ME), is a condition which causes persistent exhaustion, which is not relieved by sleep or rest. It is relatively common in children and can be very disabling, seriously affecting their education, family and social life. In the UK, national guidance (NICE) recommends that children suffering from CFS/ME should be offered graded exercise therapy (GET), cognitive behavioural therapy (CBT) or activity management (AM), all of which teach people ways of coping with their condition day-to-day. GET has been shown to be very helpful in adults suffering from CFS/ME; however there are very few studies which look at how effective it is in children, and whether it is an economical treatment option. The aim of this study is to find out how successful and cost-effective GET is compared to AM for the treatment of CFS/ME in children.
Who can participate?
Children between 8 and 17 years old who have been diagnosed with CFS/ME.
What does the study involve?
Participants are randomly allocated into two groups. Children in group one are given AM, and those in group two are given GET. The children and their parents are then interviewed in order to judge how well the treatment is working.
What are the possible benefits and risks of participating?
Participants will not benefit directly from taking part in the study although it may prove enjoyable contributing to the research. There are no risks of participating in the study.
Where is the study run from?
Centre for Child & Adolescent Health, University of Bristol (UK)
When is the study starting and how long is it expected to run for?
September 2015 to March 2019
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Professor Esther Crawley
A randomised controlled trial investigating the effectiveness and cost effectiveness of graded exercise therapy compared to activity management for paediatric CFS/ME
It is feasible and acceptable to conduct a trial investigating the effectiveness and cost-effectiveness of graded exercise therapy compared to activity management for the treatment of CFS/ME in children.
The aim of this study is to
1. Estimate the effectiveness of Graded Exercise Therapy compared to Activity Management for paediatric CFS/ME
2. Estimate the cost effectiveness of Graded Exercise Therapy and Activity Management
NRES Committee South West - Frenchay, 03/07/2015, ref: 15/SW/0124
Favourable ethical opinion to amend from feasibility to full trial: NRES Committee South West - Frenchay, 06/03/2017, ref: 15/SW/0124
Multi-centre randomised controlled feasibility trial
Multi-centre randomised controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Topic: Children; Subtopic: All Diagnoses; Disease: All Diseases
Feasibility trial and full trial:
Children are randomly allocated into two groups:
Group 1: Activity management (AM) will be delivered by CFS/ME specialists that are not physiotherapists (occupational therapists, nurses, psychologists). Therapists will receive guidance on the Mandatory, Prohibited and Flexible components. Activity management aims to convert a “boom-bust” pattern of activity (lots one day and little the next) to a baseline with the same daily amount. For children/teenagers with CFS/ME these are almost entirely cognitive activities: school, school work, reading.
Group 2: Graded Exercise Therapy (GET) will be delivered by referral to a GET-trained specialist CFS/ME physiotherapist who will receive guidance on the Mandatory, Prohibited and Flexible components. Children will be offered advice that is focused on exercise with detailed assessment of current physical activity, advice about exercise and a programme including timed daily exercise. Children will be asked to record the amount of exercise and taught to use a heart rate monitor with target heart rates.
Participants will be asked to complete follow up at baseline, 6 and 12 months.
Primary outcome measure
Feasibility and acceptability of investigating GET in a randomised controlled trial measured after 1 year.
Physical function is measured with the 36-Item Short Form Health Survey (SF36, physical function sub scale), collected at the 6 month time point.
Secondary outcome measures
No secondary outcome measures.
1. School attendance is measured as percentage attendance of expected sessions
2. Fatigue is measured using the Chalder Fatigue score
3. Pain is measured using the visual analogue scale
4. Depression and anxiety are measured using the Spence Children’s Anxiety Scale (SCAS) and the Hospital Anxiety and Depression Scale (HADS, if they are 12-17 years old)
5. Health related quality of life is measured using the EQ-5D-Y
All of the above outcomes will be measured via child self-completed questionnaires at baseline, 6 and 12 months as well as a measure of physical function the SF36-PFS at 12 months.
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Diagnosis of chronic fatigue syndrome or myalgic encephalomyelitis (made using NICE guidance)
2. Aged between 8 and 17 years inclusive
Target number of participants
Planned Sample Size: 222; UK Sample Size: 222
Participant exclusion criteria
1. Too severely affected to attend hospital appointments (and require a domiciliary assessment)
2. Referred for CBT at their first clinical assessment
3. Unable to attend follow up appointments
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Royal United Hospital
Trial participating centre
Newcastle upon Tyne NHS Foundation Trust (feasiblity trial only)
Children and young people Royal Victoria Infirmary Queen Victoria Road
Newcastle upon Tyne
National Institute for Health Research
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Publication in a peer reviewed journal.
IPD sharing statement:
We intend to making data available to researchers after publication of the trial results. We will ensure information on how to access the data is publicly available.
Intention to publish date
Participant level data
To be made available at a later date
Basic results (scientific)
2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27377634