Therapist-supervised exercise compared to usual care advice after distal radius fractures in people aged 50 years and over
| ISRCTN | ISRCTN78953418 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78953418 |
| IRAS number | 329536 |
| Secondary identifying numbers | CPMS 58092, NIHR205011, IRAS 329536 |
- Submission date
- 21/09/2023
- Registration date
- 04/10/2023
- Last edited
- 08/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Wrist fractures are an extremely common injury, representing about 1 in 5 of all broken bones seen in UK hospitals. After breaking their wrist, people are often provided with basic advice by the person who is treating them about how to get their wrist working again. We would like to find out if giving patients more detailed exercise advice will improve how quickly and how well they recover from a broken wrist. This study will compare two different ways of helping people recover from a broken wrist. The information we gather will provide scientific evidence about the effects of receiving additional sessions with a therapist. As therapy appointments aren’t always convenient for patients, and it is important to make the best use of NHS time and resources, the WISE study aims to find out if the extra exercise advice helps with recovery.
Who can participate?
People aged 50 years and over who have broken their wrist
What does the study involve?
If the patient is happy to take part in this study, a researcher will ask some simple questions and check the patient's medical history to confirm that they are eligible. If the patient is eligible, the researcher will ask them to sign a consent form on a computer. If the patient is not at the hospital, a member of the research team will be able to document the patient's consent over the telephone. The researcher will also ask them to complete a short questionnaire that asks about health, level of activity, and injury. This questionnaire should take no more than 20 minutes to complete.
The researcher will then use a computer program to allocate participants to one of the two treatment groups. Participants will be randomised to either usual care or therapist-supervised exercise in addition to usual care.
Usual care is the normal advice that is provided by the hospital.
If participants are randomised to therapist-supervised exercise, they will receive three physiotherapy or occupational therapy sessions. These sessions may be face-to-face, by videoconference or telephone, depending on local policies. Participants will receive a detailed booklet containing advice and exercises, and will also have access to a website with the same information, which includes videos with instructions on how to do the exercises.
All participants will then be asked to complete a further questionnaire at three and six months post randomisation.
What are the possible benefits and risks of participating?
Fully qualified, registered health professionals will provide treatment. They will use widely recognised treatments in the NHS. We hope the information from this study will be used to help treat people with broken wrists more effectively.
Patients are unlikely to be harmed by this treatment. They may experience soreness after completing some of the exercises. This is normal, and patients will be given advice on how to manage this soreness. We are not able to pay travel expenses for attendance at therapy sessions as this part of patients treatment.
Where is the study run from?
University of Oxford (UK)
When is the study starting and how long is it expected to run for?
March 2023 to August 2025
Who is funding the study?
National Institute for Health and Care Research (NIHR) Research for Patient Benefit Programme (UK)
Who is the main contact?
Dr David Keene, wise@ndorms.ox.ac.uk
Contact information
Principal Investigator
Kadoorie Centre
Level 3, John Radcliffe Hospital
Headington
Oxford
OX3 9DU
United Kingdom
 ORCID ID |
0000-0001-7249-6496 |
|---|---|
| Phone | +44 1865 227912 |
| wise@ndorms.ox.ac.uk |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home, Other therapist office |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Progressive resistance and flexibility exercises versus usual care advice for improving pain and function after distal radius fracture in adults aged 50 years or over: the WISE randomised superiority trial |
| Study acronym | WISE trial |
| Study objectives | To compare the clinical effectiveness of a therapist-supervised exercise programme, to usual care advice, in improving pain and function after distal radius fractures in adults aged 50 years and over. |
| Ethics approval(s) |
Approved 09/10/2023, Yorkshire & The Humber - Leeds East Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8012; leedseast.rec@hra.nhs.uk), ref: 23/YH/0201 |
| Health condition(s) or problem(s) studied | Distal radius fracture |
| Intervention | Participants will be randomised to one of the following groups: - Usual care advice: consisting of advice, and an information leaflet (if part of usual care) - Therapist-Supervised exercise: usual care advice plus one session up to 60 minutes with a physio or occupational therapist to introduce a stretching and strengthening exercise programme. A further two sessions of up to 30 minutes over 12 weeks after the first session will provide guidance on progression of the exercise programme. If the hospital has pre-established practices for remote video or telephone consultations then the participant will be able to access this mode of delivery. Participants will be provided with a high-quality written and illustrated guide, and a website to support them with carrying out the exercises independently. |
| Intervention type | Behavioural |
| Primary outcome measure | Wrist pain and function measured by the Patient-Rated Wrist Evaluation (PRWE) at six months post-randomisation |
| Secondary outcome measures | 1. Wrist pain and function measured by the PRWE at baseline and three months post-randomisation 2. Upper extremity function measured by the PROMIS Physical Function (Upper Extremity) at baseline, three and six months post-randomisation 3. Health related quality of life measured by EuroQol 5 Dimensions EQ-5D-5L at baseline, three and six months post-randomisation 4. Confidence in ability to exercise measured by the Self-Efficacy for Exercise scale (SEE) at baseline, three and six months post-randomisation 5. Exercise adherence measured by self-reported exercise frequency at three and six months post-randomisation 6. Health resource use measured by self-reported bespoke questionnaire at three and six months post-randomisation 7. Related complications measured by patient questionnaires and site complications reporting at three and six months post-randomisation 8. Upper limb muscle strength measured by Grip Strength (cylindrical grip) at six months post-randomisation |
| Overall study start date | 01/03/2023 |
| Completion date | 31/08/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 50 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 588; UK Sample Size: 588 |
| Key inclusion criteria | 1. Patient aged 50 years or over with a distal radius fracture treated surgically or non-surgically 2. Willing and able to give informed consent for participation in the study |
| Key exclusion criteria | 1. Injury is more than two months old 2. There is evidence that the patient would be unable to participate in therapy or a self-guided exercise programme provided by a participating centre or adhere to trial procedures (including cognitive impairment and fracture/surgery complications such as Complex Regional Pain Syndrome) 3. Open fractures with a Gustilo & Anderson grading > 1 |
| Date of first enrolment | 30/11/2023 |
| Date of final enrolment | 31/01/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Southmead Road
Westbury-On-Trym
Bristol
BS10 5NB
United Kingdom
Sandford Road
Cheltenham
GL53 7AN
United Kingdom
Combe Park
Bath
BA1 3NG
United Kingdom
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Lyndhurst Road
Worthing
BN11 2DH
United Kingdom
Skipton Road
Steeton Keighley
BD20 6TD
United Kingdom
Hardwick Road
Hardwick
Stockton-on-Tees
TS19 8PE
United Kingdom
Cambridge Biomedical Campus
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Lydeard House
Taunton
TA1 5DA
United Kingdom
Abeford Road
Wakefield
WF1 4DG
United Kingdom
Treliske
Truro
TR1 3LJ
United Kingdom
Sponsor information
University/education
CTRG
Joint Research Office
1st Floor
Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7GB
England
United Kingdom
| Phone | +44 (0)1865 572221 |
|---|---|
| ctrg@admin.ox.ac.uk | |
| Website | http://www.ox.ac.uk/ |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/08/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 08/07/2025 | 08/07/2025 | Yes | No |
Editorial Notes
08/07/2025: Publication reference added.
08/11/2023: The following changes were made:
1. The recruitment start date was changed from 31/10/2023 to 30/11/2023.
2. Ethics approval date was added.
21/09/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
