MAGENTA: Managed activity graded exercise in teenagers and pre-adolescents
| ISRCTN | ISRCTN23962803 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23962803 |
| IRAS number | 176764 |
| Secondary identifying numbers | CPMS 19035 |
- Submission date
- 03/09/2015
- Registration date
- 03/09/2015
- Last edited
- 04/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
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?
Chris Metcalfe, chris.metcalfe@bristol.ac.uk
Contact information
Scientific
Bristol Trials Centre, Bristol Medical School, 1-5 Whiteladies Road
Bristol
BS8 1NU
United Kingdom
 ORCID ID |
0000-0001-8318-8907 |
|---|---|
| chris.metcalfe@bristol.ac.uk |
Study information
| Study design | Current study design as of 27/03/2017: Feasibility trial: Multi-centre randomized controlled feasibility trial Full trial: Multi-centre randomized controlled trial Previous study design: Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | https://www.bristol.ac.uk/academic-child-health/research/research/cfsme/magenta/magenta-trial/magenta-pis/ |
| Scientific title | A randomised controlled trial investigating the effectiveness and cost effectiveness of graded exercise therapy compared to activity management for paediatric CFS/ME |
| Study acronym | MAGENTA |
| Study hypothesis | Current hypothesis as of 27/03/2017: 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 Previous hypothesis: 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. |
| Ethics approval(s) | 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 |
| Condition | Topic: Children; Subtopic: All Diagnoses; Disease: All Diseases |
| Intervention | Current intervention as of 27/03/2018: 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. Previous intervention: 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. |
| Intervention type | Behavioural |
| Primary outcome measure | Current primary outcome measures as of 27/03/2018: 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. Previous primary outcome measures: Feasibility and acceptability of investigating GET in a randomised controlled trial measured after 1 year. |
| Secondary outcome measures | Current secondary outcome measures as of 27/03/2018 (prior to this date there were no 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 study start date | 01/01/2014 |
| Overall study end date | 23/06/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 8 Years |
| Upper age limit | 17 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 222; UK Sample Size: 222 |
| Total final enrolment | 237 |
| 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 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 | 10/09/2015 |
| Recruitment end date | 23/03/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Bath
BA1 3NG
United Kingdom
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom
Sponsor information
Hospital/treatment centre
Royal United Hospital Bath NHS Trust
Upper Borough Walls
Bath
BA1 1RL
England
United Kingdom
"ROR" |
https://ror.org/05va5gy74 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/04/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Publication in a peer reviewed journal. |
| IPD sharing plan | The study participants provided consent to their data being retained and used by the University of Bristol for present and future research and teaching purposes. Individual study data cannot be released to research groups outside of the University of Bristol. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 04/07/2016 | Yes | No | |
| Results article | results | 02/05/2019 | 18/06/2019 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 19/12/2019 | 10/10/2023 | Yes | No | |
| Statistical Analysis Plan | version 1.0 | 30/10/2019 | 04/01/2024 | No | No |
| Results article | Primary results | 02/03/2024 | 04/03/2024 | Yes | No |
Additional files
Editorial Notes
04/03/2024: The following changes were made to the trial record:
1. Publication reference added.
2. The participant level data sharing statement was added.
04/01/2024: The following changes were made to the trial record:
1. The statistical analysis plan was uploaded as an additional file.
2. The IRAS number was added.
3. The overall start date was changed from 15/01/2013 to 01/01/2014.
4. The study website was added.
5. Link to participant information sheet added.
6. The intention to publish date was changed from 01/12/2019 to 01/04/2024.
7. The contact was updated.
10/10/2023: Publication reference added.
18/06/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
11/10/2018: Internal review. The following changes have been made:
1. Changes have been made to the hypothesis, study design, intervention, primary outcome measures and secondary outcome measures to add back in the previous versions that were overwritten in error on 27/03/2017 and to add the date the information was added.
2. The Participant inclusion criteria: Age group has been changed from 'Adult' to 'Child' since participants are aged 8-17 years.
13/08/2018: The following changes have been made to the trial record:
1. The overall trial end date has been changed from 31/03/2019 to 23/06/2019
2. The recruitment end date has been changed from 07/03/2018 to 23/03/2018
3. The address has been updated
08/08/2018: The overall trial start date has been changed from 10/09/2015 to 15/01/2013.
06/08/2018: Internal review.
22/06/2018: The recruitment start date has been changed from 01/09/2015 to 10/09/2015. This change has been confirmed by the University of Bristol.
29/03/2018: The recruitment end date has been changed from 31/03/2018 to 07/03/2018.
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.
