Home Orthostatic Training in Chronic Fatigue Syndrome
| ISRCTN | ISRCTN89726128 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89726128 |
| Secondary identifying numbers | HOT-CFS |
- Submission date
- 30/04/2009
- Registration date
- 22/06/2009
- Last edited
- 29/01/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Julia Newton
Scientific
Scientific
Newcastle upon Tyne Hospitals NHS Foundation Trust
Freeman Hospital
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Study information
| Study design | Randomised controlled feasibility study |
|---|---|
| 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 below to request a patient information sheet |
| Scientific title | Home Orthostatic Training in Chronic Fatigue Syndrome: a randomised controlled feasibility study |
| Study acronym | HOT CFS |
| Study objectives | Home orthostatic training is safe and feasible in chronic fatigue syndrome. |
| Ethics approval(s) | Sunderland Local Research Ethics Committee (LREC) approved on the 5th July 2005 (ref: 05/Q0904/37) |
| Health condition(s) or problem(s) studied | Chronic fatigue syndrome |
| Intervention | Patients will receive routine clinical care including withdrawal of potential culprit medications, and conservative and abortive advice as is our usual practice. Following full written consent they will be enrolled in the study. Patients will be asked to return to the Tilt Room for investigation on four separate occasions over a six month period. Baseline Investigation of autonomic function and haemodynamics will be performed at visit 1 and the technique of home orthostatic training (HOT therapy) or sham will be taught. They will be encouraged to be accompanied by a relative or friend, but this will not be mandatory. There will then be three re-evaluation visits where, autonomic function and haemodynamic measures will be repeated. These will occur at one week, four weeks and six months from the onset of training. Throughout the study period patients will receive a weekly telephone call from one of the investigators to assess progress and to provide encouragement. |
| Intervention type | Other |
| Primary outcome measure | 1. Study compliance. Timepoints: 1 week, 4 weeks, 6 months. 2. Autonomic function. Timepoints: baseline, 1 week, 4 weeks, 6 months. |
| Secondary outcome measures | Fatigue. Timepoints: baseline, 1 week, 4 weeks, 6 months. |
| Overall study start date | 01/01/2008 |
| Completion date | 01/01/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 |
| Key inclusion criteria | 1. Chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME) patients 2. Both males and females, aged 18 years and over 3. Patients who fulfil the Fukuda diagnostic criteria 4. Patients with an autonomic phenotype, i.e., have a composite autonomic symptom scale of greater than 32.5 |
| Key exclusion criteria | 1. Inability to give informed consent 2. Patients on drugs which can affect the autonomic nervous system which cannot be discontinued safely 3. Inability to stand for up to 40 minutes due to muscular or neurological disorders, cardiac transplantation, or pregnancy |
| Date of first enrolment | 01/01/2008 |
| Date of final enrolment | 01/01/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne
NE7 7DN
United Kingdom
NE7 7DN
United Kingdom
Sponsor information
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Freeman Hospital
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
England
United Kingdom
| Website | http://www.newcastle-hospitals.org.uk/ |
|---|---|
"ROR" |
https://ror.org/05p40t847 |
Funders
Funder type
Government
CFS/ME Northern Clinical Network, NHS Networks (UK)
No information available
Nuffield Foundation (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2010 | Yes | No |
