Education and eXercise Training in early Rheumatoid Arthritis (EXTRA) study
| ISRCTN | ISRCTN14268051 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14268051 |
| Secondary identifying numbers | PRF/07/03 |
- Submission date
- 02/05/2008
- Registration date
- 12/06/2008
- Last edited
- 02/09/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Lindsay Bearne
Scientific
Scientific
Division of Applied Biomedical Research
Shepherd's House
Guys Campus
London
SE1 1UL
United Kingdom
| Phone | +44 (0)20 7848 6332 |
|---|---|
| lindsay.bearne@kcl.ac.uk |
Study information
| Study design | Prospective pragmatic assessor-blind multi-centred randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| 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 | Rehabilitation of upper limb sensorimotor dysfunction in patients with early rheumatoid arthritis: an assessor blind, pragmatic randomised controlled trial |
| Study acronym | EXTRA study |
| Study objectives | 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(s) | Kings College Hospital Research Ethics Committee, 27/08/2008, ref: 08/H0808/118 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 30/09/2008 |
| Completion date | 30/09/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 130 |
| Key inclusion criteria | 1. RA of less than 5 years duration 2. Over 18 years of age, either sex |
| Key exclusion criteria | 1. Unstable disease 2. Surgery or physiotherapy to upper limb within the previous 6 months 3. Unable to give informed consent |
| Date of first enrolment | 30/09/2008 |
| Date of final enrolment | 30/09/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Division of Applied Biomedical Research
London
SE1 1UL
United Kingdom
SE1 1UL
United Kingdom
Sponsor information
King's College London (UK)
University/education
University/education
Division of Applied Biomedical Research
Shepherds House
Guy's Campus
London
SE1 1UL
England
United Kingdom
| Phone | +44 (0)20 7848 6330 |
|---|---|
| fiona.cook@kcl.ac.uk | |
| Website | http://www.kcl.ac.uk/schools/biohealth/research/applied/ |
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Research organisation
Physiotherapy Research Foundation (UK) (ref: PRF/07/03)
No information available
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 | 01/02/2015 | Yes | No |
