Condition category
Musculoskeletal Diseases
Date applied
02/05/2008
Date assigned
12/06/2008
Last edited
02/09/2014
Prospective/Retrospective
Prospectively 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

Dr Lindsay Bearne

ORCID ID

Contact details

Division of Applied Biomedical Research
Shepherd's House
Guys Campus
London
SE1 1UL
United Kingdom
+44 (0)20 7848 6332
lindsay.bearne@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PRF/07/03

Study information

Scientific title

Rehabilitation of upper limb sensorimotor dysfunction in patients with early rheumatoid arthritis: an assessor blind, pragmatic randomised controlled trial

Acronym

EXTRA study

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

Kings College Hospital Research Ethics Committee, 27/08/2008, ref: 08/H0808/118

Study design

Prospective pragmatic assessor-blind multi-centred randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Rheumatoid arthritis

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Disability of Arm, Shoulder and Hand Questionnaire (DASH), re-measured at each assessment.

Secondary outcome measures

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.

Overall trial start date

30/09/2008

Overall trial end date

30/09/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. RA of less than 5 years duration
2. Over 18 years of age, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

130

Participant exclusion criteria

1. Unstable disease
2. Surgery or physiotherapy to upper limb within the previous 6 months
3. Unable to give informed consent

Recruitment start date

30/09/2008

Recruitment end date

30/09/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Division of Applied Biomedical Research
London
SE1 1UL
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

Division of Applied Biomedical Research
Shepherds House
Guy's Campus
London
SE1 1UL
United Kingdom
+44 (0)20 7848 6330
fiona.cook@kcl.ac.uk

Sponsor type

University/education

Website

http://www.kcl.ac.uk/schools/biohealth/research/applied/

Funders

Funder type

Research organisation

Funder name

Physiotherapy Research Foundation (UK) (ref: PRF/07/03)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25173349

Publication citations

  1. Results

    Manning VL, Kaambwa B, Ratcliffe J, Scott DL, Choy E, Hurley MV, Bearne LM, Economic evaluation of a brief Education, Self-management and Upper Limb Exercise Training in People with Rheumatoid Arthritis (EXTRA) programme: a trial-based analysis., Rheumatology (Oxford), 2014, doi: 10.1093/rheumatology/keu319.

Additional files

Editorial Notes