Graded Exercise Therapy guided SElf-help Treatment for CFS/ME
| ISRCTN | ISRCTN22975026 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22975026 |
| Secondary identifying numbers | 12053 |
- Submission date
- 24/05/2012
- Registration date
- 24/05/2012
- Last edited
- 27/06/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
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?
Prof. Peter D White (Principal Investigator)
p.d.white@qmul.ac.uk
Contact information
Scientific
Wolfson Institute of Preventive Medicine
Barts and The London School of Medicine and Dentistry
Centre for Psychiatry
London
EC1A 7BE
United Kingdom
 ORCID ID |
0000-0002-8193-5355 |
|---|---|
| p.d.white@qmul.ac.uk |
Study information
| Study design | Randomised interventional trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study 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(s) | London Bridge Research Ethics Committee, 23/11/2011, ref: 11/LO/1572 |
| Condition | Health services research |
| Intervention | Current interventions as of 28/02/2017: 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 (http://www.wolfson.qmul.ac.uk/images/pdfs/getset/GET%20guide%20booklet%20version%201%2022062010.pdf), 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. Participants will be asked 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. The qualitative study will explore patient experiences of Guided graded Exercise Self-help (GES) delivered as part of the randomised controlled trial. The study will investigate the differences and similarities in treatment perceptions and experiences of guided graded exercise self-help (GES) among CFS/ME participants reporting an improvement compared to those reporting a deterioration in their condition. Follow Up Length: 3 month(s); Study Entry : Single Randomisation only Long Term Follow-up: 12 months from study entry Previous 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 |
| Intervention type | Other |
| Primary outcome measure | 1. SF-36 physical function subscale (SF-36PF) measured at 12 weeks from randomisation Added 21/07/2015: 2. Chalder fatigue scale measured at 12 weeks and 1 year Updated 28/02/2017: 2. Chalder Fatigue Scale measured at 12 weeks |
| Secondary outcome measures | Clinical global impression change (CGI) score measured 12 weeks from baseline |
| Overall study start date | 16/05/2012 |
| Overall study end date | 01/12/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 218; Actual Sample Size: 211 |
| 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 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 | 01/12/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
EC1A 7BE
United Kingdom
Maidstone
ME16 9QQ
United Kingdom
Sponsor information
University/education
School of Medicine and Dentistry
Clinical Sciences Research Centre
Rutland Place
Charterhouse Square
London
EC1M 6BQ
England
United Kingdom
| Website | http://www.qmul.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/026zzn846 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/04/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | The protocol has been published and the main paper, qualitative paper and long-term outcomes paper including health economics will be published in 2017. |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 08/06/2016 | Yes | No | |
| Results article | results | 22/07/2017 | Yes | No |
Editorial Notes
27/06/2017: Publication reference added.
28/02/2017: The target number of participants was changed from 'Planned Sample Size: 218' to 'Planned Sample Size: 218; Actual Sample Size: 211'
10/06/2016: Publication reference added.
30/07/2015: The overall trial end date was changed from 31/03/2014 to 01/12/2015.
21/07/2015: The target number of participants was changed from 178 to 218.
