Title: PEP-TALK: A behaviour change physiotherapy intervention to increase physical activity following hip and knee replacement: a pragmatic randomised controlled trial.
Funder: Department of Health and Social Care

Abstract: Total hip (THR) and knee replacement (TKR) are successful orthopaedic procedures which improve joint pain and discomfort for people with osteoarthritis [1]. Over 206,000 THRs and TKRs were performed in the UK in 2015 [1]. Up to 50% have other diseases such as hypertension, cardiovascular disease, diabetes, depression and multi-site joint pain [2-4]. This has significant negative impact on health-related quality of life (HRQOL) [5,6]. Furthermore, these diseases place a substantial economic burden on the NHS; estimated costs of treating uncomplicated hypertension alone are &pound;106-&pound;229 million/year [7] and uncomplicated diabetes being &pound;2.1 billion/year [8]. Physical activity is proven to be a clinically- and cost-effective intervention which significantly reduces the impact of these diseases [9,10]. However, people after THR or TKR are often no more active and, importantly, do not know how to be. Approximately 60% of people undergoing THR or TKR have challenges which make engaging in physical activity difficult, most notably psychosocial barriers and fear-avoidance beliefs [11]. They therefore do not gain the health benefits physical activity could have on their HRQOL. AIM: We will answer the question: does a group exercise and behaviour-change intervention targeted to increase physical activity participation increase HRQOL and clinical outcomes following a THR or TKR? DESIGN: Two-armed, pragmatic, parallel randomised controlled trial to assess effectiveness of a group exercise and behaviour-change intervention to increase physical activity in people following THR or TKR. PPI INVOLVEMENT: Patients have been involved in designing this trial and developing the research question. One of our co-researchers has first-hand experience of trying to increase their levels of physical activity following joint replacement. She will provide input to patient-facing documentation, assist with data interpretation and dissemination. SETTING: Four UK hospital trusts (St George s, Kings College, Norfolk and Norwich Hospital, Oxford University Hospitals). INCLUSION CRITERIA: (1) people following primary unilateral THR or TKR where the indication for surgery is degenerative joint pathology (not trauma); (2) people who do not meet physical activity levels to benefit health (using the General Practice Physical Activity Questionnaire [38]); (3) people with a Charlson Comorbidity Index [39] of 5 points or above. Participants will be approached during their pre-operative assessment and, after confirming eligibility, will enrol prior to hospital discharge following their surgery. EXPERIMENTAL INTERVENTION: 6 sessions (once weekly) group behaviour-change treatment and physiotherapy group exercise after their THR or TKR, and 3 follow-on telephone calls. The behaviour change intervention will be delivered by a physiotherapist trained in how to support individuals to increase physical activity participation. CONTROL: 6 sessions (once weekly) physiotherapy group exercise alone (no behaviour change treatment nor follow-up phone calls). MEASUREMENT OF OUTCOME: Primary: University of California, Los Angeles (UCLA) activity scale [56] to assess physical activity. Secondary outcomes: Function (Lower Extensity Functional Scale; Oxford Hip and Knee Scores), self-efficacy, psychological distress, complications or adverse events, health economic and health-resource utilisation data. End-point: 6 months and 12 months (primary end-point). SAMPLE SIZE: Based on the UCLA Activity Scale at 12 months, 250 participants will be required. ANALYSIS: Between-group difference with a multivariate linear regression analysis adjusted for the stratification factors. If not normally distributed then non-parametric techniques (e.g. Mann-Whitney or Kruskal-Wallis Test) will be used with no adjustment. PROJECT TIMESCALE: Based on 2016 UK National Joint Registry data, the cohort will be recruited within a 12-month period (including a 3-month contingency). RESEARCH BENEFIT TO PATIENTS AND NHS: This trial will determine whether group-based treatment for people who have difficulty in being more active, could improve these individual s health and well-being, and could save the NHS money by reducing visits to GP practices because of other medical problems which physical activity can reduce.

Lay abstract: Over 206,000 hip and knee replacements were performed in the UK last year. As well as joint pain, half of these people have other diseases such as high blood pressure, heart disease, diabetes and depression. Physical activity can improve these conditions. Before a hip or knee replacement, it can be difficult to be physically active because of pain and fatigue. It is hoped that after joint replacement, this improves so people can be more active. However, people after hip or knee replacement are often no more active than before and, importantly, do not know how to be. They miss out on some of the health benefits which joint replacement can offer. This study will test a group exercise and behaviour change treatment which targets barriers people have which can stop them being physically active, to maximise their health and the effect of this on NHS needs. People will be randomly allocated by chance (like tossing a coin) to have treatment consisting of either (a) 6 sessions (once weekly) behaviour change treatment and physiotherapy group exercise with other people after their hip or knee replacement, and 3 follow-on telephone calls, or (b) 6 sessions (once weekly) physiotherapy group exercise alone (no behaviour change treatment nor follow-up phone calls). Patients will be asked to complete questionnaires to measure the benefits of each treatment 6 and 12 months after their operation. Patients have helped design this study. One of our researchers has first-hand experience of trying to increase their levels of physical activity after joint replacement. If shown to be effective, this group-based treatment for people who have difficulty in being more active, could improve these individual s health and well-being, and could save the NHS money by reducing visits to GP practices because of other medical problems which physical activity can reduce.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: MUSCULOSKELETAL