Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HOT-CFS
Study information
Scientific title
Home Orthostatic Training in Chronic Fatigue Syndrome: a randomised controlled feasibility study
Acronym
HOT CFS
Study hypothesis
Home orthostatic training is safe and feasible in chronic fatigue syndrome.
Ethics approval
Sunderland Local Research Ethics Committee (LREC) approved on the 5th July 2005 (ref: 05/Q0904/37)
Study design
Randomised controlled feasibility study
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
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
Phase
Not Applicable
Drug names
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 trial start date
01/01/2008
Overall trial end date
01/01/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant 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
Recruitment start date
01/01/2008
Recruitment end date
01/01/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne
NE7 7DN
United Kingdom
Sponsor information
Organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Sponsor details
Freeman Hospital
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
CFS/ME Northern Clinical Network, NHS Networks (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Nuffield Foundation (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
United Kingdom
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
Basic results (scientific)
Publication list
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19912315
Publication citations
-
Results
Sutcliffe K, Gray J, Tan MP, Pairman J, Wilton K, Parry SW, Newton JL, Home orthostatic training in chronic fatigue syndrome--a randomized, placebo-controlled feasibility study., Eur. J. Clin. Invest., 2010, 40, 1, 18-24, doi: 10.1111/j.1365-2362.2009.02225.x.