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G73(P) The MAGENTA protocol: The feasibility and acceptability of conducting a trial investigating t

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JaimeS

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Full title:
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

By -- you guessed it:
  1. AB Brigden1,
  2. LB Beasant1,
  3. WH Hollingworth1,
  4. CM Metcalfe1,
  5. DG Gaunt1,
  6. NM Mills1,
  7. RJ Jago2,
  8. EC Crawley1
Abstract:



Introduction Paediatric chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME) is a relatively common and disabling yet there is a limited evidence base for treatment. There is good evidence that Graded Exercise Therapy (GET) is moderately effective in adults with CFS/ME but there is no evidence for the effectiveness, cost effectiveness, acceptability or best method of delivery for paediatric CFS/ME.

This study aims to investigate the acceptability and feasibility of a carrying out a multi-centre randomised control trial (RCT) investigating the effectiveness of GET compared with activity management for mildly and moderately affected children.

Methods and analysis 100 paediatric patients (8–17 years) with CFS/ ME will be recruited from three UK specialist NHS CFS/ME services (Bath, Cambridge and Newcastle). Patients will be randomised (1:1) to receive either Graded exercise Therapy (GET) or Activity Management (AM). Feasibility analysis will include: the number of young person’s eligible, approached and consented to the trial; attrition rate and treatment compliance; questionnaire and accelerometer completion rates. Integrated qualitative methods will ascertain perceptions of feasibility and acceptability of recruitment, randomisation and the intervention. All Adverse events (SAE/AEs) will be monitored to assess the safety of the trial.

Ethics and dissemination The trial has received ethical approval from the National Research Ethics Service Committee NRES Committee South West – Frenchay (15/SW/0124).

________________________________________________

"Patients will be randomised (1:1) to receive either Graded exercise Therapy (GET) or Activity Management (AM)."

Activity, or else activity. Is the latter self-paced activity?

It's hard for me to believe someone else hasn't pounced on this article, so if this is cross-posted let me know and I will delete the thread.


-J
 

A.B.

Senior Member
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3,780
accelerometer completion rates

Hopefully that won't be dropped halfway through the trial like in PACE.

Activity, or else activity. Is the latter self-paced activity?

They probably mean the activity management described here:

http://www.ayme.org.uk/activity-mgt

Which involves keeping a diary of activities and making small increases. It's a form of self management.

It does sound like a lot of effort though. I do very poorly on tasks that require so much consistency.
 

JaimeS

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Location
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I'll link to it there. I think it discusses the "first arm" of that trial:

This study will investigate the feasibility and acceptability of conducting a Randomised Controlled Trial (RCT) to investigate the effectiveness and cost-effectiveness of Graded Exercise Therapy compared to Activity Management for the treatment of CFS/ME in children. We will interview participants, their parents, researchers and clinicians to improve the study and the interventions. If MAGENTA is feasible, we will move on to a full study and find out whether GET is effective and cost effective.

"we will move on to a full study and find out whether GET is effective and cost effective."

Now we're here.
 

Denise

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Full title:
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


-J

@JaimeS - Can you add the link where you found this?

Edit to clarify - It looks as though this may be the link .
The trial registration # for the abstract is the same as
ISRCTN23962803


The MAGENTA trial: can we investigate the effectiveness and cost effectiveness of managed activity compared to graded exercise in teenagers and pre-adolescents.
 
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Cheshire

Senior Member
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1,129
From the peer-review paper:
upload_2016-7-6_19-8-27.png


Crawley has to be taught what aerobic exercise is by her reviewer.
That woman is writing a protocol for an exercise therapy trial.
Everything is just perfectly normal and FINE.
 
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A.B.

Senior Member
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I also find it funny that they originally tried to portrait reliance on self reported outcomes as strength. A reviewer took issue with this... but now self reported outcomes are listed in the "Strengths and limitations" box in an ambiguous way so that it is not clear whether this is a stregnth or a limitation. They sure love vagueness.
 

Scarecrow

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Everything is just perfectly normal and FINE.
......well that's what the other reviewer thought!!
http://bmjopen.bmj.com/content/6/7/e011255.reviewer-comments.pdf said:
REVIEWER
Lucy Clark
QMUL, London
REVIEW RETURNED
10-Mar-2016

GENERAL COMMENTS
This study protocol investigating the feasibility of carrying out a RCT of GET for CFS/ME is written clearly and in enough detail for it to be repeated. It includes all the information it should regarding funding and ethics, and the references seem to be relevant to this population and up-to-date. The title and abstract are clear, and it describes an interesting study that, when completed, should add to the literature on GET for CFS/ME.
Lucy Clark, QMUL, one of the GETSET investigators. NICE.
 

Yogi

Senior Member
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1,132
......well that's what the other reviewer thought!!

Lucy Clark, QMUL, one of the GETSET investigators. NICE.

The faces behind the names and both are exercise physios rather than medical doctors- UNETHICAL
LucyClark.jpg

Exercise physiologist
http://www.wolfson.qmul.ac.uk/a-z-staff-profiles/lucy-clark

Suzanne Broadbent
https://works.bepress.com/suzanne_broadbent/
http://www.jacobspublishers.com/index.php/journal-of-sports-medicine-editorial-board
Journal of *** SPORTS*** Medicine Editorial Board
EB_Suzanne_Broadbent.jpg
 
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Dolphin

Senior Member
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17,567
Background information on the reviewer Lucy Clark:


Lucy Clark was previously Lucy Darbishire. Some people might recognise that name from earlier studies.


Http://www.wolfson.qmul.ac.uk/a-z-staff-profiles/lucy-clark#publications


http://www.wolfson.qmul.ac.uk/a-z-staff-profiles/lucy-clark#profile


In the 1990's Dr Clark completed a both bachelor and masters degrees in Sport and Exercise Sciences, also working in health and fitness during that time.


In 1998 she started working as a researcher at Kings College London on a randomised controlled trial comparing graded exercise with cognitive behaviour therapy for primary care patients with fatigue.


In 2005 she completed her PhD in this field and continued to research fatigue in primary care. At this time she also assisted with some research into headache in primary care and took on some lecturing roles. In 2007 she moved to Queen Mary, to undertake a study looking at the cytokine response to exercise in secondary care patients with chronic fatigue syndrome. More recently she has been managing a trial of guided self-help for patients diagnosed with CFS in secondary care, the emphasis of the guidance being a graded return to exercise and activity. She also continues to work as a personal trainer outside of QMUL.


http://www.wolfson.qmul.ac.uk/a-z-staff-profiles/lucy-clark#expertise


Expertise


Chronic fatigue syndrome

Randomised controlled trials

Research methods

Trial management

Complex interventions

Graded exercise therapy

Exercise psychology and physiology

Exercise as a treatment for chronic illness
 
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