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Wrist injury strengthening exercise for improving pain and function after distal radius fracture in adults aged 50 or over

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12290145
Enrollment
72
Registered
2021-01-28
Start date
2020-11-01
Completion date
Unknown
Last updated
2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distal radius fracture Injury, Occupational Diseases, Poisoning Fracture of lower end of radius

Interventions

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 rand

Sponsors

University of Oxford
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

England, United Kingdom

Contacts

Public ContactKate Herbert
wise@ndorms.ox.ac.uk+44 (0)1865 227318

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 19, 2026