A trial at two Barts & the London NHS Trust clinics, led by Prof Peter D White, intends to develop a further understanding of:
• How beneficial for CFS/ME patients is graded exercise therapy (GET, recommended by the NICE guideline as being “one of only two therapies for which there is research evidence of benefit”)?
• And can GET be harmful (as “most ME charities,” which “do not recommend it,” believe)?
According to information provided in the UK Clinical Research Network Database (for the full listing, locations & contact info see http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=12053):
The trial’s recruitment goal of 178 participants is 14% met at this date.
Who may apply to this UK Multi-Center Trial?
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. The clinics are:
• St. Bartholomews Hospital, London (Dr. Lucy Clark, contact)
• Barts and the London School of Medicine and Dentistry (Dr. PD White, contact).
Patients must be 18 years or over, speak and read English adequately to provide informed consent and read the guided support booklet, and have no “comorbid condition that requires exercise to be performed only in the presence of a doctor” and no “active suicidal thoughts.”
The title of the trial (UKCRN ID 12053) is: “Graded Exercise Therapy guided SElf-help Treatment (GETSET) for patients with chronic fatigue syndrome/myalgic encephalomyelitis: a randomised controlled trial in secondary care
“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, cost effectiveness 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 arm:
• 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.”