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

Conditions

Topic: Children

Brigden A, Beasant L, Gaunt D, Hollingworth W, Mills N, Solomon-Moore E, Jago R, Metcalfe C, Garfield K, Wray C, Trist A, Vilenchik V, Grayson C, Crawley E.

2019-12-195 citations

10.1186/s40814-019-0525-3

Managed Activity Graded Exercise iN Teenagers and pre-Adolescents (MAGENTA) feasibility randomised controlled trial: study protocol

Amberly Brigden, Lucy Beasant, William Hollingworth, Chris Metcalfe, Daisy Gaunt et al. (8 authors)

BMJ Open2016-07-0116 citations

10.1136/bmjopen-2016-011255

G73(P) The MAGENTA protocol: 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

AB Brigden, LB Beasant, W. C. Hollingworth, C.W. Metcalfe, DG Gaunt et al. (8 authors)

Archives of Disease in Childhood2016-04-011 citations

10.1136/archdischild-2016-310863.70

Interventions

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 tha

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Measure

Time frame

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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Countries

England, United Kingdom

Outcome results

None listed