Condition category
Nervous System Diseases
Date applied
30/04/2009
Date assigned
22/06/2009
Last edited
29/01/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Julia Newton

ORCID ID

Contact details

Newcastle upon Tyne Hospitals NHS Foundation Trust
Freeman Hospital
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom

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 measures

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

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

http://www.newcastle-hospitals.org.uk/

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

foundation

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

Results - basic reporting

Publication summary

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19912315

Publication citations

  1. 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.

Additional files

Editorial Notes