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

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2021
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. CONDITION: Distal radius fracture ; Injury, Occupational Diseases, Poisoning ; Fracture of lower end of radius PRIMARY OUTCOME: ; 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; 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 SECONDARY OUTCOME: ; 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;
Epistemonikos ID: 94e299fd6471c434a114bfd13e1330900bedeace
First added on: Aug 24, 2024