Wrist injury strengthening exercise for improving pain and function after distal radius fracture in adults aged 50 or over
| ISRCTN | ISRCTN12290145 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12290145 |
| IRAS number | 282917 |
| Secondary identifying numbers | IRAS 282917, CPMS 47701 |
- Submission date
- 20/11/2020
- Registration date
- 28/01/2021
- Last edited
- 21/09/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English Summary
Background and study aims
Wrist fractures are an extremely common injury, representing about 1 in 5 of all broken bones seen in UK hospitals. 1 in 10 women up to 90 years old will have a wrist fracture, with most occurring after a simple fall from standing height. Initial treatment for this fracture is either with an operation (for more severe breaks) or with a splint or cast.
After a wrist fracture, patients may experience long-term muscle weakness of the hand and arm, with an impact on their quality of life and wellbeing. There may also be long-lasting impacts on daily activities such as personal hygiene, domestic chores, and preparing meals.
Currently the care program offered to patients after the initial treatment varies between hospitals, but the majority of patients will be given some basic exercise instruction. This study will investigate whether adding in a programme of stretching and strengthening exercises for the hand and arm will help in the patient’s recovery. These specific exercises are thought to improve wrist function and help with future activities of daily living.
Who can participate?
Patients aged over 50 who have a distal radius fracture.
What does the study involve?
Participants will be allocated at random to one of three groups:
1. Usual care consisting of advice and an advice leaflet
2. Independent exercise: usual care plus a single session with a physio or occupational therapist to introduce the stretching and strengthening exercise programme. Provision of a high-quality written and illustrated guide, and website to support participants with carrying out the exercises independently.
3. Supervised exercise: usual care, plus the guide and website available to the independent exercise group, but these participants would have three sessions with a therapist. The additional two sessions with the therapist will offer opportunities to discuss the progression of the exercises and resolve any problems.
What are the possible benefits and risks of participating?
The information from this study will be used to help treat people with broken wrists in the future. Exercises are already used in the NHS for people with broken bones. Participants are unlikely to be harmed by this treatment. The therapist will assess them to help make sure they are given exercises at the right level. Participants may experience some soreness in their wrist after completing exercises. They will be given advice on how to manage this soreness.
People sometimes feel uncomfortable answering certain questions about their health. If the researcher, physiotherapist, or follow-up questionnaire asks participants questions that they are uncomfortable with then they do not have to answer them.
Where is the study run from?
University of Oxford (UK)
When is the study starting and how long is it expected to run for?
July 2020 to May 2022
Who is funding the study?
National Institute of Health Research (NIHR) (UK)
Who is the main contact?
Kate Herbert
wise@ndorms.ox.ac.uk
Contact information
Public
Adult trials office
Lvl 3
Kadoorie Centre
John Radcliffe Hospital
Headley Way
Oxford
OX3 9DU
United Kingdom
| Phone | +44 (0)1865 227318 |
|---|---|
| wise@ndorms.ox.ac.uk |
Scientific
Adult trials office
Lvl 3
Kadoorie Centre
John Radcliffe Hospital
Headley Way
Oxford
OX3 9DU
United Kingdom
| Phone | +44 (0)1865223121 |
|---|---|
| david.keene@ndorms.ox.ac.uk |
Study information
| Study design | Multicentre parallel three-group feasibility randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | WISE - Wrist Injury Strengthening Exercise: a randomized multicentre feasibility study of flexibility and resistance exercises versus usual care for improving pain and function after distal radius fracture in adults aged 50 years or over |
| Study acronym | WISE feasibility study |
| Study hypothesis | It is hypothesised that introducing structured flexibility and resistance exercise training has the potential to improve functional recovery by optimising recovery of muscle strength of the hand and upper limb. |
| Ethics approval(s) | Approved 24/12/2020, South Central - Hampshire B Research Ethics Committee (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK; +44 (0)207 104 8290; hampshireb.rec@hra.nhs.uk), REC ref: 20/SC/0433 |
| Condition | Distal radius fracture |
| Intervention | Randomisation will be completed online. The trial will employ 1:1:1 allocation, stratified by centre and initial fracture management (surgical vs non-surgical). Participants will be allocated at random to one of three different study groups: 1. Usual care consisting of advice and an advice leaflet 2. Independent exercise: usual care plus a single session with a physio or occupational therapist to introduce the stretching and strengthening exercise programme. Provision of a high-quality written and illustrated guide, and website to support participants with carrying out the exercises independently. 3. Supervised exercise: usual care, plus the guide and website available to the independent exercise group, but these participants would have three sessions with a therapist. The additional two sessions with the therapist will offer opportunities to discuss progression of the exercises and resolve any problems. The sessions will take place over a 12 week period, the first one lasting up to 60 minutes, and subsequent sessions up to 30 minutes. The participants will be followed up for 6 months post randomisation. |
| Intervention type | Behavioural |
| Primary outcome measure | The main aim of the feasibility randomised controlled trial is to determine whether a future definitive trial would be feasible. To determine the feasibility of a definitive RCT the success criteria are: 1. Patient engagement with the trial, measured by recruitment rate over 6 months of recruitment 2. Acceptability of the interventions, as measured by adherence (number and content of therapy appointments attended/website visits) and patient/staff interviews over 6 months of recruitment 3. Participant retention, as measured by the proportion of randomised patients providing outcome data at 6 months |
| Secondary outcome measures | The researchers will collect the proposed definitive trial outcome measures as part of this feasibility study to determine their viability in a future definitive trial. 1. Wrist pain and function measured using Patient Reported Wrist Evaluation (PRWE) at baseline, 3 and 6 months 2. Upper extremity function measured using PROMIS Upper Extremity at baseline, 3 and 6 months 3. Confidence in ability to do exercise measured using Self-efficacy Exercise Score (SEE) at baseline, 3 and 6 months 4. Self-reported exercise frequency measured using a trial-specific questionnaire at 3 and 6 months 5. Health-related quality of life measured using EQ-5D-5L at baseline, 3 and 6 months 6. Self-reported health resource use measured using a trial-specific questionnaire at 3 and 6 months 7. Reporting of adverse events using patient questionnaires and site complication at baseline, 3 and 6 months 8. Muscle strength measured using a dynamometer at 6 months 9. Balance and mobility measured using a trial-specific questionnaire at baseline, 3 and 6 months |
| Overall study start date | 01/07/2020 |
| Overall study end date | 19/05/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 72 |
| Total final enrolment | 117 |
| Participant inclusion criteria | 1. Adult patients aged 50 years and older 2. Distal radius fracture treated surgically or non-surgically 3. Informed consent for participation in the study |
| Participant exclusion criteria | 1. Injury is more than 2 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 |
| Recruitment start date | 01/11/2020 |
| Recruitment end date | 30/04/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Headley Way
Headington
Oxford
OX3 9DU
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 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Research for Patient Benefit Programme, RfPB
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 14/09/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The study protocol and results will be published in open-access journals in accordance with CONSORT statement extension for pilot and feasibility studies and the template for intervention description and replication (TIDieR) complex intervention reporting guidance. The researchers will work with networks to disseminate findings, for example through annual meetings and newsletters of the Association of Trauma and Orthopaedic Chartered Physiotherapists, Orthopaedic Trauma Society, and the Fragility Fracture Network. The findings will also be shared with patients and the public more widely through local and national charity newsletters and other media channels. The researchers will be supported in their dissemination by the Oxford NIHR Biomedical Research Centre communications officer. Social media will be utilised to share news on study progress. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr David Keene (david.keene@ndorms.ox.ac.uk) 3 years after the publication of the main trial results. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 07/03/2022 | 18/03/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
21/09/2023: The acronym was changed from 'WISE' to 'WISE feasibility study'
18/03/2022: The following changes were made to the trial record:
1. The overall trial end date was changed from 31/03/2022 to 19/05/2022.
2. The intention to publish date was changed from 01/10/2022 to 14/09/2022.
3. Total final enrolment, IPD sharing statement and publication reference added.
08/01/2021: Trial's existence confirmed by South Central - Hampshire B Research Ethics Committee.
