Title: A randomised controlled feasibility trial of a prehabilitation intervention in frail older people undergoing total hip or knee replacement
Funder: Department of Health and Social Care

Abstract: Research question: Will people who are frail or pre-frail and waiting for a hip or knee replacement be willing to participate in, and adhere to, a protein and exercise intervention during the 12 weeks prior to their operation? Background: Frailty is a syndrome whereby decline in physiological reserve and function confers increased vulnerability to physiological stressors. The prevalence of frailty increases with age and is associated with poor recovery and/or death following an operation. According to the National Joint Registry, in 2018 more than 200,000 primary hip or knee replacements were conducted in England, Wales, Northern Ireland and the Isle of Man. Studies suggest that around one-third to one-half of those waiting for a hip/knee replacement are either frail or prefrail. Pre-operative exercise and nutritional supplements may lead to fewer post-operative complications and faster recovery, but few studies have included people who are frail/pre-frail, and none have been conducted within the NHS. Aims and Objectives: The long-term objective is to perform a definitive multicentre RCT to evaluate the clinical and cost-effectiveness of a pre-operative protein and exercise intervention in frail/pre-frail individuals waiting for a hip or knee replacement. However, before this, several uncertainties must be addressed. The aim of the proposed trial is to determine the feasibility of a definitive RCT, and the primary objectives are to assess recruitment rate, retention rate, adherence and acceptability, data collection and data completion rates, and estimated sample size for a definitive trial. Methods: We propose a feasibility RCT of a prehabilitation intervention consisting of tailored exercise and protein supplementation, for 12-weeks prior to total hip or knee replacement, with a nested qualitative study. We will recruit 60 participants across two sites, with age &ge;65yrs, and pre-frail or frail according to SHARE-FI. Participants will be randomised to usual care or usual care plus daily protein and exercise. Outcome measures include recruitment, retention, and adherence rates, WOMAC, and length of stay. Semi-structured interviews will be conducted in a subset of participants and in some who declined participation, and focus groups will be conducted with clinicians to explore barriers to recruitment. Timelines: This is a 24-month project, including a 6-month set-up phase, 12 months for recruitment and data collection, and 6 months for data interpretation and dissemination and development of the definitive trial, if warranted. Anticipated Impact and Dissemination: The findings will allow us to determine whether progression to a definitive trial across multiple centres is possible. If warranted, the definitive trial may ultimately change clinical guidelines for frail/pre-frail individuals undergoing hip or knee replacement. Given the year-on-year increase in hip and knee replacements within an increasingly aging and potentially frail population, the definitive trial could have a substantial impact on many patients and the NHS. Dissemination plans aim for maximum coverage. Findings will be disseminated to study participants, our PPI group, presented at leading orthopaedic and ageing scientific conferences, published in high impact orthopaedic and ageing journals, and shared via social media platforms such as Twitter.

Lay abstract: Aim: To see if we can improve recovery from surgery in older people having hip or knee replacements by giving them protein and asking them to exercise daily (according to ability) in the weeks before their operation. First, we want to see if people are willing to do this by running a small study. If they are, we will design a larger study to test whether it improves recovery. Background: One-third to one-half of people waiting for hip/knee replacements are frail (which generally means they have poor strength and function) or at risk of becoming frail ( pre-fail ) and may not recover as well after surgery as those who are not. They may experience more complications and longer hospital stay. Studies have looked at ways to help people to prepare before their surgery, to increase their chances of an easier recovery. An improved diet with extra protein and pre-operative exercise may lead to fewer post-operative complications and faster recovery. However, few studies have included frail/pre-frail people, and none have looked at pre-operative protein and exercise in this group waiting for hip or knee replacement in the NHS. Design and methods: We will ask 60 people who are frail/pre-frail and waiting for hip or knee replacement to take part. We will use a computer to randomly assign participants to one of two groups. One will follow usual care. This can vary between NHS Trusts, but may involve education classes and attending hospital for assessment before surgery. No participants in this group will be asked to change their usual care. The other group will be given protein products to add to their diet and follow a tailored exercise programme for 12-weeks before their operation. All participants will complete questionnaires about health and quality of life. Information about post-operative recovery and time spent in hospital will be collected from medical records. We will invite some participants to be interviewed about their experiences of taking part. Patient and public involvement (PPI): We worked with a local PPI group, which includes people who have had joint replacement, to develop this application. They tested several protein products and shaped the exercise component. We will continue to work with them to further develop and refine the study (e.g., co-producing information for participants) and discuss potential problems during the study. Dissemination: We will share the findings with our PPI group and study participants and publish results in a scientific journal. If we find that people are willing to take part in a study like this and follow the diet and exercises, we will apply for funding for a larger study. The larger study will test whether these pre-surgery interventions benefit patients by improving recovery after hip or knee replacement.

Research activity codes: 6.7 PHYSICAL
Health categories: MUSCULOSKELETAL