Condition category
Nervous System Diseases
Date applied
24/05/2012
Date assigned
24/05/2012
Last edited
25/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English 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

Trial website

Contact information

Type

Scientific

Primary contact

Prof PD White

ORCID ID

Contact details

Wolfson Institute of Preventive Medicine
Barts and The London School of Medicine and Dentistry
Centre for Psychiatry
London
EC1A 7BE
United Kingdom
p.d.white@qmul.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

12053

Study information

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

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.

Ethics approval

London Bridge Research Ethics Committee, 23/11/2011, ref: 11/LO/1572

Study design

Randomised interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Health Services Research

Intervention

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

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

SF-36 physical function subscale (SF-36PF) measured 12 weeks from randomisation

Secondary outcome measures

Clinical global impression change (CGI) score measured 12-weeks from baseline

Overall trial start date

16/05/2012

Overall trial end date

31/03/2014

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 178; UK Sample Size: 178;

Participant 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

Recruitment start date

16/05/2012

Recruitment end date

31/03/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Wolfson Institute of Preventive Medicine
London
EC1A 7BE
United Kingdom

Sponsor information

Organisation

Queen Mary University of London (UK)

Sponsor details

School of Medicine and Dentistry
Clinical Sciences Research Centre
Rutland Place
Charterhouse Square
London
EC1M 6BQ
United Kingdom
+44 (0)20 7882 5555

Sponsor type

University/education

Website

http://www.qmul.ac.uk/

Funders

Funder type

Government

Funder name

NIHR Research for Patient Benefit Programme (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes