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Results of the feasibility phase of the Managed Activity Graded Exercise iN Teenagers and Pre-Adolescents (MAGENTA) Randomised Controlled Trial of treatments for Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis

Research output: Contribution to journalArticle

Original languageEnglish
Article number151 (2019)
Number of pages18
JournalPilot and Feasibility Studies
Volume5
DOIs
DateAccepted/In press - 6 Nov 2019
DatePublished (current) - 19 Dec 2019

Abstract

Background:

Chronic fatigue syndrome (CFS) also known as myalgic encephalomyelitis (ME) is relatively common in young people and causes significant disability. Graded exercise therapy (GET) and activity management are recommended by the National Institute for Health and Care Excellence (NICE) despite a limited evidence-base for either treatment in paediatric CFS/ME. This paper reports on feasibility and acceptability measures from the feasibility phase of the ongoing MAGENTA randomised controlled trial (RCT) investigating GET versus activity management for young people with CFS/ME.

Methods:

Setting: Three specialist secondary care National Health Service (NHS) Paediatric CFS/ME services (Bath, Cambridge and Newcastle).

Participants: Young people aged 8–17 years with a diagnosis of mild to moderate CFS/ME. Young people were excluded if they were severely affected, referred to cognitive behavioural therapy (CBT) at initial assessment or unable to attend clinical sessions.

Interventions: GET and activity management delivered by physiotherapists, occupational therapists, nurses and psychologists. Families and clinicians decided the number (typically 8–12) and frequency of appointments (typically every 2–6 weeks).

Outcome Measures: Recruitment and follow-up statistics. We used integrated qualitative methodology to explore the feasibility and acceptability of the trial processes and the interventions.

Results:
80/161 (49.7%) of eligible young people were recruited at two sites between September 2015 and August 2016, indicating recruitment to the trial was feasible. Most recruitment (78/80; 97.5%) took place at one centre. Recruitment consultations, online consent and interventions were acceptable, with less than 10% in each arm discontinuing trial treatment. Response rate to the primary outcome (the SF36-PFS at 6 months) was 91.4%. Recruitment, treatment and data collection were not feasible at one centre. The site was withdrawn from the study.

In response to data collected, we optimised trial processes including using Skype for recruitment discussions; adapting recruiter training to improve recruitment discussions; amending the accelerometer information leaflets; shortening the resource use questionnaires; and offering interventions via Skype. These amendments have been incorporated into the full trial protocol.

Conclusions
Conducting an RCT investigating GET versus activity management is feasible and acceptable for young people with CFS/ME.

    Research areas

  • Chronic fatigue syndrome, Myalgic encephalomyelitis, CFS/ME, Graded exercise therapy, Activity management, Feasibility study, Randomisation controlled trial, Qualitative research

    Structured keywords

  • BRTC

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    Rights statement: This is the final published version of the article (version of record). It first appeared online via Springer Nature at https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-019-0525-3. Please refer to any applicable terms of use of the publisher.

    Final published version, 1.45 MB, PDF document

    Licence: CC BY

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