|
ISRCTN
|
ISRCTN14268051
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Education and eXercise Training in early Rheumatoid Arthritis (EXTRA) study
|
|
Scientific title
|
Rehabilitation of upper limb sensorimotor dysfunction in patients with early rheumatoid arthritis: an assessor blind, pragmatic randomised controlled trial
|
|
Acronym
|
EXTRA study
|
|
Serial number at source
|
PRF/07/03
|
|
Study hypothesis
|
Main research question:
Do people with early rheumatoid arthritis (RA) who receive an upper limb, home exercise programme supplemented with supervised group exercise and educational sessions have less upper limb disability than those receiving usual care?
|
|
Ethics approval
|
Ethics approval pending from Kings College Hospital Research Ethics Committee - submission planned May 2008.
|
|
Study design
|
A prospective, pragmatic, assessor blind, multi-centred, randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Rheumatoid arthritis
|
|
Participants - inclusion criteria
|
1. RA of less than 5 years duration
2. Over 18 years of age, either sex
|
|
Participants - exclusion criteria
|
1. Unstable disease
2. Surgery or physiotherapy to upper limb within the previous 6 months
3. Unable to give informed consent
|
|
Anticipated start date
|
30/09/2008
|
|
Anticipated end date
|
30/09/2012
|
|
Status of trial
|
Ongoing
|
|
Patient information material
|
Not available in web format, please use the contact details below to request a patient information sheet
|
|
Target number of participants
|
130
|
|
Interventions
|
12-week home exercise programme supplemented with four group exercise and educational sessions versus usual medical care.
In the randomised controlled trial (RCT) all participants will be followed up 3 months and 9 months after initial assessment (the duration of the intervention is 3 months therefore final follow up will be 6 months after cessation of the intervention). Study duration is 9 months in total.
Approximately fifteen participants (purposive sample based on DASH score, gender etc.) who complete the intervention arm of the study, will be invited to attend for a 30 minute qualitative interview to explore the motivations and barriers to exercise adherence, experiences of the RCT, etc.
|
|
Primary outcome measure(s)
|
Disability of Arm, Shoulder and Hand Questionnaire (DASH), re-measured at each assessment.
|
|
Secondary outcome measure(s)
|
1. Upper limb muscle strength
2. Joint position sense
3. Function and quality of life measures
All outcome measures are re-measured at each assessment.
|
|
Sources of funding
|
Physiotherapy Research Foundation (UK) (PRF/07/03)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Lindsay
Bearne
|
|
Address
|
Division of Applied Biomedical Research
Shepherd's House
Guys Campus
|
|
City/town
|
London
|
|
Zip/Postcode
|
SE1 1UL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7848 6332
|
|
Email
|
lindsay.bearne@kcl.ac.uk
|
|
Sponsor
|
King's College London (UK)
|
|
Address
|
Division of Applied Biomedical Research
Shepherds House
Guy's Campus
|
|
City/town
|
London
|
|
Zip/Postcode
|
SE1 1UL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7848 6330
|
|
Email
|
fiona.cook@kcl.ac.uk
|
|
Sponsor website:
|
http://www.kcl.ac.uk/schools/biohealth/research/applied/
|
|
Date applied
|
02/05/2008
|
|
Last edited
|
20/06/2008
|
|
Date ISRCTN assigned
|
12/06/2008
|
