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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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18 March 2024 |
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Main ID: |
ISRCTN23962803 |
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Date of registration:
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03/09/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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MAGENTA: Managed activity graded exercise in teenagers and pre-adolescents
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Scientific title:
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A randomised controlled trial investigating the effectiveness and cost effectiveness of graded exercise therapy compared to activity management for paediatric CFS/ME |
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Date of first enrolment:
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10/09/2015 |
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Target sample size:
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222 |
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Recruitment status: |
Completed |
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URL:
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https://www.isrctn.com/ISRCTN23962803 |
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Study type:
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Interventional |
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Study design:
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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 (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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England
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Chris
Metcalfe |
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Address:
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Bristol Trials Centre, Bristol Medical School, 1-5 Whiteladies Road
BS8 1NU
Bristol
United Kingdom |
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Telephone:
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- |
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Email:
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chris.metcalfe@bristol.ac.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Diagnosis of chronic fatigue syndrome or myalgic encephalomyelitis (made using NICE guidance)
2. Aged between 8 and 17 years inclusive
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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Topic: Children; Subtopic: All Diagnoses; Disease: All Diseases
Nervous System Diseases
Paediatric chronic fatigue syndrome, myalgic encephalomyelitis (CFS/ME)
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Intervention(s)
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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: Grade
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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.
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Secondary ID(s)
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CPMS 19035
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Nil known
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Source(s) of Monetary Support
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National Institute for Health Research
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Ethics review
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Status:
Approval date:
Contact:
Old ethics approval format; 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
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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23/06/2019 |
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URL:
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