MAGENTA: Managed activity graded exercise in teenagers and pre-adolescents

Not Applicable

Completed

• Conditions: Subtopic: All Diagnoses; Paediatric chronic fatigue syndrome, myalgic encephalomyelitis (CFS/ME); Topic: Children; Disease: All Diseases; Nervous System Diseases

• Registration Number: ISRCTN23962803
• Lead Sponsor: Royal National Hospital for Rheumatic Disease (UK)

Brief Summary

2016 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/27377634 protocol 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31206075 results (added 18/06/2019) 2019 Results article in https://pubmed.ncbi.nlm.nih.gov/31890263/ (added 10/10/2023) 2024 Results article in https://doi.org/10.1007/s00431-024-05458-x Primary results (added 04/03/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-03
• Study Completion: 2019-06-23
• Last Update Posted: 18 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 237

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measures as of 27/03/2018:<br>Feasibility trial:<br>Feasibility and acceptability of investigating GET in a randomised controlled trial measured after 1 year.<br><br>Full trial:<br>Physical function is measured with the 36-Item Short Form Health Survey (SF36, physical function sub scale), collected at the 6 month time point.<br><br>Previous primary outcome measures:<br>Feasibility and acceptability of investigating GET in a randomised controlled trial measured after 1 year.

Secondary Outcome Measures

Name	Time	Method
Current secondary outcome measures as of 27/03/2018 (prior to this date there were no secondary outcome measures):<br>Feasibility trial:<br>No secondary outcome measures.<br><br>Full trial:<br>1. School attendance is measured as percentage attendance of expected sessions<br>2. Fatigue is measured using the Chalder Fatigue score<br>3. Pain is measured using the visual analogue scale<br>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)<br>5. Health related quality of life is measured using the EQ-5D-Y<br><br>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.