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NB: The information displayed below does not replace the protocol. The latest protocol version should always be consulted before making clinical decisions.
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GETSET
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Graded Exercise Therapy guided SElf-help Treatment (GETSET) for patients with chronic fatigue syndrome/myalgic encephalomyelitis: a randomised controlled trial in secondary care
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Topic
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Generic Relevance & Cross Cutting Themes
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Portfolio Eligibility
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Automatically eligible
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ISRCTN
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22975026
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EudraCT
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MREC N°
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11/LO/1572
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UKCRN ID
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12053
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WHO ID
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Research Summary
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Chronic fatigue syndrome, also known as myalgic encephalomyelitis (CFS/ME) is a chronic disabling condition of no known cause and with no established cure. It affects about one in a hundred people. The National Institute for Health and Clinical Excellence (NICE) guidelines on the management of CFS/ME recommend graded exercise therapy (GET) as one of only two treatments for which there is research evidence of benefit. In contrast most ME charities believe that
GET can be harmful, and they do not recommend it.
This study will test the acceptability, effectiveness, costeffectiveness
and safety of Graded Exercise Therapy guided SElf-help Treatment (GETSET) for patients with CFS/ME on treatment waiting lists at hospital clinics. GETSET has been designed to incorporate the best elements of GET provided by current and previous research trials, paying particular attention to safety and acceptability. Patients will be randomly allocated to one of two trial arms. In the first, participants will be sent a copy of a GET self-help guide and asked to follow it as described in a booklet. Patients will follow the six steps described in the GETSET booklet that will inform them how to use graded exercise or physical activity to feel less tired and reduce disability in a safe way. They will be given individual guidance either face-to-face or by telephone/Skype soon after being randomised and another 3 times in the following 8 weeks, by a physiotherapist experienced in treating people with CFS/ME, on how to use and implement GETSET. Those who feel the need may contact the physiotherapist thereafter. The second trial arm will continue to receive standard medical care (SMC) from their specialist doctor. We will ask people to rate their own health and disability at the end of the treatment period and also measure how much consequent treatment they receive afterwards, to see if those who had the GETSET need less face-to-face treatment.
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Study Type
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Interventional
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Design Type
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Not specified
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Disease(s)
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Health Services Research
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Phase
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N/A
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Current Status
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Open
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Closure Date
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3/31/2014
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Global Sample Size
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178
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Global Recruitment to Date
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 44% |
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Geographical Scope
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UK Multi-Centre
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Lead Country
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England
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Open to new sites
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No
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Main Inclusion Criteria
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Patients attending two CFS/ME specialist clinics in London and receiving a diagnosis of CFS/ME from a specialist doctor, and going onto a waiting list for clinic treatment. Patients must be 18 years or over, speak and read English adequately to provide informed consent and read the guided support booklet.
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Main Exclusion Criteria
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Not receiving a diagnosis of CFS/ME. Having a comorbid
condition that requires exercise to be performed only in the
presence of a doctor. Being under the age of 18. Having active suicidal thoughts.
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Chief Investigator(s)
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| Prof PD White |
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Further details, please contact
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Dr Lucy Clark
Barts and The London Trust
St. Bartholomews Hospital
West Smithfield
London
EC1A 7BE
UNITED KINGDOM
Tel: 020 3465 5698
l.clark@qmul.ac.uk
| Prof PD White
Barts and The London Trust
Centre for Psychiatry
Wolfson Institute of Preventive Medicine
Barts and The London School of Medicine and Dentistry
London
EC1A 7BE
UNITED KINGDOM
Tel: 020 3465 5696
p.d.white@qmul.ac.uk
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| Funder(s) |
NIHR Research for Patient Benefit (RfPB)
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| Sponsor(s) |
Queen Mary University of London
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