Condition category
Nervous System Diseases
Date applied
03/09/2015
Date assigned
03/09/2015
Last edited
06/09/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Esther Crawley

ORCID ID

Contact details

Centre for Child & Adolescent Health
Oakfield House
15-23 Oakfield Grove
Bristol
BS8 2BN
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

19035

Study information

Scientific title

A randomised controlled trial investigating the effectiveness and cost effectiveness of graded exercise therapy compared to activity management for paediatric CFS/ME

Acronym

MAGENTA

Study hypothesis

Feasibility trial:
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.

Full trial:
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

Ethics approval

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

Study design

Feasibility trial:
Multi-centre randomised controlled feasibility trial

Full trial:
Multi-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Children; Subtopic: All Diagnoses; Disease: All Diseases

Intervention

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.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Feasibility trial:
Feasibility and acceptability of investigating GET in a randomised controlled trial measured after 1 year.

Full trial:
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

Feasibility trial:
No secondary outcome measures.

Full trial:
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

01/09/2015

Overall trial end date

31/03/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosis of chronic fatigue syndrome or myalgic encephalomyelitis (made using NICE guidance)
2. Aged between 8 and 17 years inclusive

Participant type

Patient

Age group

Adult

Gender

Both

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

01/09/2015

Recruitment end date

31/03/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal United Hospital
Combe Park
Bath
BA1 3NG
United Kingdom

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
NE1 4LP
United Kingdom

Sponsor information

Organisation

Royal National Hospital for Rheumatic Disease (UK)

Sponsor details

Royal United Hospital Bath NHS Trust
Upper Borough Walls
Bath
BA1 1RL
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

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

01/12/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27377634

Publication citations

Additional files

Editorial Notes

06/09/2017: Recruitment end dates have been updated from 30/06/2018 to 31/03/2018. Individual patient data sharing statement has been added 27/03/2017: The following changes have been made to the record in order to incorporate the full trial into the record: 1. The titles have been updated to encompass both parts of the trial (previous public title: The MAGENTA trial: can we investigate the effectiveness and cost effectiveness of managed activity compared to graded exercise in teenagers and pre-adolescents; previous scientific title: The feasibility and acceptability of conducting a trial investigating the effectiveness and cost effectiveness of Graded Exercise Therapy compared to Activity Management for paediatric CFS/ME: A feasibility randomised controlled trial) 2. The overall trial end date has been updated from 31/12/2018 to 31/03/2019 3. The target number of participants has been updated from 100 to 222 (this includes the 100 participants from the feasibility trial) 4. The planned publication date has been added 5. The hypothesis and outcome measures have been added for the full trial 6. The date of ethical approval for the full trial has been added 07/02/2017: The overall trial end date has been updated from 31/08/2016 to 31/12/2018 and the recruitment end date has been updated from 31/08/2016 to 30/06/2018. 06/07/2016: Publication reference added.