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Graded Exercise Therapy guided SElf-help Treatment for CFS/ME
ISRCTN ISRCTN22975026
DOI 10.1186/ISRCTN22975026
ClinicalTrials.gov identifier
EudraCT number
Public title Graded Exercise Therapy guided SElf-help Treatment for CFS/ME
Scientific title Graded Exercise Therapy guided SElf-help Treatment (GETSET) for patients with chronic fatigue syndrome/myalgic encephalomyelitis: a randomised controlled trial in secondary care
Acronym GETSET
Serial number at source 12053
Study hypothesis 1. GETSET will be more effective at improving physical disability than usual specialist medical care alone as shown by a statistically significant difference between the two arms of the trial three months after randomisation.
2. GETSET will be acceptable to patients diagnosed as having CFS/ME in specialist secondary care clinics, as demonstrated by less than 25 per cent of eligible patients declining participation in the trial, and more than 75 per cent of those participating being satisfied with the approach.
3. There will be no statistically significant differences in the number of participants suffering serious adverse effects, serious adverse reactions, or a serious deterioration in their condition.
4. There will be no statistically significant difference in the cost-effectiveness between the two interventions.
Lay summary Background and study aims
Chronic fatigue syndrome, also known as myalgic encephalomyelitis (CFS/ME), is a chronic disabling condition of no known cause. It affects about one in a hundred people. Guidelines 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; however, they do regard self-help strategies positively. This study will test the acceptability, effectiveness, cost-effectiveness and safety of graded exercise therapy delivered as a guided/supported self-help treatment for patients with CFS/ME attending hospital clinics.

Who can participate?
Patients with a diagnosis of CFS/ME attending two specialist clinics.

What does the study involve?
Participants will be randomly allocated to one of two study groups. In one group participants are guided, by a physiotherapist, through the graded exercise programme (GETSET) described in a self-help booklet, of which they will have a copy. Participants 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 planned and safe way. They will be given individual supportive guidance in how to apply the booklet over the next 8 weeks with up to 90 minutes of face-to-face/telephone and/or Skype support by a physiotherapist experienced in treating people with CFS/ME. In the other group participants continue to follow specialist medical advice as usual. We will ask people to rate their own health and disability at the end of the treatment period and also measure how much consequent face-to-face treatment they receive, to see if those who had the GETSET need less face-to-face treatment in the service afterwards.

What are the possible benefits and risks of participating?
The possible benefit is that the treatment we are offering may help you, although it is not guaranteed. The risk is that although GET appears to be safe when applied properly by trained staff, it has never been delivered as guided self-help before. Some patient surveys suggest GET can make symptoms worse, but experts believe this happens when the therapy is not used properly or when there is not good professional supervision. We will carefully monitor patients progress through the GET with Skype/telephone contacts.

Where is the study run from?
The study is run from Barts and The London School of Medicine and Dentistry at Queen Mary University of London (UK).

When is the study starting and how long is it expected to run for?
The study started in May 2012 and will continue until the end of 2014.

Who is funding the study?
National Institute for Health Research (NIHR) (UK).

Who is the main contact?
Professor Peter D White (Principal Investigator)
p.d.white@qmul.ac.uk
Ethics approval London Bridge Research Ethics Committee, 23/11/2011, ref: 11/LO/1572
Study design Randomised interventional trial
Countries of recruitment United Kingdom
Disease/condition/study domain Health Services Research
Participants - inclusion criteria 1. Patients attending two CFS/ME specialist clinics in London
2. Patients receiving a diagnosis of CFS/ME from a specialist doctor,and going onto a waiting list for clinic treatment
3. Patients must be 18 years or over
4. Speak and read English adequately to provide informed consent and read the guided support booklet.
5. Target Gender: Male & Female
6. Lower Age Limit 18 years
Participants - exclusion criteria 1. Not receiving a diagnosis of CFS/ME
2. Having a comorbid
condition that requires exercise to be performed only in the presence of a doctor
3. Being under the age of 18
4. Having active suicidal thoughts
Anticipated start date 16/05/2012
Anticipated end date 31/03/2014
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants Planned Sample Size: 178; UK Sample Size: 178;
Interventions Guided support, A copy of the GETSET booklet, one 30 minute consultation face-to-face, by Skype or telephone, and 3 further Skype of telephone contacts. Intervention over 9 weeks.; Follow Up Length: 3 month(s); Study Entry : Single Randomisation only
Primary outcome measure(s) SF-36 physical function subscale (SF-36PF) measured 12 weeks from randomisation
Secondary outcome measure(s) Clinical global impression change (CGI) score measured 12-weeks from baseline
Sources of funding NIHR Research for Patient Benefit Programme (UK)
Trial website
Publications
Contact name Prof  PD  White
  Address Wolfson Institute of Preventive Medicine
Barts and The London School of Medicine and Dentistry
Centre for Psychiatry
  City/town London
  Zip/Postcode EC1A 7BE
  Country United Kingdom
  Email p.d.white@qmul.ac.uk
Sponsor Queen Mary University of London (UK)
  Address School of Medicine and Dentistry
Clinical Sciences Research Centre
Rutland Place
Charterhouse Square
  City/town London
  Zip/Postcode EC1M 6BQ
  Country United Kingdom
  Tel +44 (0)20 7882 5555
  Email
  Sponsor website: http://www.qmul.ac.uk/
Date applied 24/05/2012
Last edited 25/11/2013
Date ISRCTN assigned 24/05/2012
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