Title: WISE (Wrist Injury Strengthening Exercise): a randomised multicentre feasibility study of resistance exercise versus usual care for optimising function after distal radius fracture in adults aged 50 years or over
Funder: Department of Health and Social Care

Abstract: Background In the UK, there are 100,000 distal radius fractures each year, representing 1 in 5 of all broken bones. The majority affect women over the age of 50. Most patients experience pain and stiffness in their wrist and develop upper limb weakness, making activities of daily living difficult. Optimising rehabilitation could improve these specific areas. Guidance in 2018 concluded there was insufficient evidence to inform rehabilitation recommendations. The James Lind Priority Setting Partnership in this area ranked rehabilitation as one of the top priorities for research. Currently, rehabilitation consists of verbal and written advice on self-management and mobilising exercises. We hypothesise that introducing resistance exercise training into the rehabilitation period has the potential to improve functional recovery. Aim: To determine the feasibility of conducting a definitive multicentre RCT of resistance exercise, compared to usual care, in improving function after distal radius fractures in adults aged 50 years and over. Objectives Feasibility objectives are to assess: Patient engagement with the trial, assessed by recruitment Acceptability of the interventions, assessed by adherence and participant and therapist experience Retention of participants in the trial Design A randomised multicentre feasibility study with an embedded qualitative study Methods Setting: Three NHS hospital fracture clinics and therapy teams Target population: Patients 50 years and over with an acute distal radius fracture treated surgically or non-surgically. Patients with concurrent injuries/illnesses contraindicating resistance exercise will be excluded. Randomisation: Using a web-based system, 1:1:1 stratified by centre and surgical/non-surgical management. Control: Usual care, consisting of verbal and written advice Intervention 1: Independent resistance exercise: Usual Care plus a single session with a physio- or occupational therapist to introduce a resistance exercise programme. Provision of a high-quality written and illustrated guide and website to support participants with progressing the exercises independently. Intervention 2: Supervised resistance exercise: Intervention 1 plus two extra sessions with a therapist providing the opportunities for feedback and collaborative problem-solving during progression of the exercise programme. Concurrent healthcare: As per usual NHS local practice, key elements will be recorded. Embedded qualitative study: Semi-structured interviews with patients and a therapist focus group to explore intervention experiences. Data collection Follow-up: 3 and 6 months. Pain and function (Patient Reported Wrist Evaluation [PRWE]), health-related quality of life, self-efficacy, health resource use, adverse events, and at 6 months only, muscle strength during power and pinch grip. Feasibility data: number of patients eligible, approached, consented, attendance and content of intervention sessions, website/manual usage, follow-up, and data completeness. Timelines for delivery Months 0-4 project and site set-up, 5-10 recruitment, 11-18 follow-up, 19-21 analysis/reporting. Anticipated Impact and Dissemination If feasibility is shown, then funding for the definitive trial will be secured. Assessment of which intervention progresses into the definitive trial will be based on participant and therapist experiences and evidence regarding the ability to deliver the intervention components. Findings will be published and shared at conferences. Our PPI co-applicants will support development of lay summaries and in developing our strategy for reaching patient networks.

Lay abstract: Wrist fractures are an extremely common injury, representing about 1 in 5 of all broken bones seen in UK hospitals. One in ten women up to 90 years 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, having an impact on their quality of life and wellbeing. There are 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, however the majority of patients will be given some basic exercise instruction. This study will investigate whether adding in a programme of resistance exercises to strengthen the muscles of 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. 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 resistance exercise: usual care plus a single session with a physio- or occupational therapist to introduce the resistance exercise programme. Provision of a high-quality written and illustrated guide and website to support participants with carrying out the exercises independently. 3. Supervised resistance exercise: usual care, plus the guide and website available to the independent resistance exercise group, but these participants would have three sessions with a therapist. The additional two sessions with the therapist will offer opportunities to discuss any problems with the exercise programme. This application is a feasibility study to test: Patient engagement with the trial, as measured by the number of patients taking part Acceptability of the interventions, as measured by the number and content of therapy appointments attended/website visits Retaining participants in the trial, as measured by the number of participants willing to provide information 6 months after their injury. We will also ask participants and therapists about their experiences and preferences for different ways of delivering resistance exercise advice. This will help us to judge if independent or supervised resistance exercise is the most suitable way of supporting people after a wrist fracture. If this feasibility study is successful, it will guide the development of a much bigger trial across the whole of the UK. In turn this could lead to recommendations about future routine NHS care practice for patients with this injury.

Research activity codes: 6.7 PHYSICAL
Health categories: MUSCULOSKELETAL;INJURIES AND ACCIDENTS