Improving physical activity, pain and function in patients waiting for hip and knee arthroplasty by combining targeted exercise training with behaviour change counselling: Study protocol for a randomised controlled trial

Background: Osteoarthritis often results in prolonged periods of reduced physical activity and is associated with adverse health outcomes, including increased risk of cardiovascular and metabolic diseases. Exercise interventions for patients on the waiting list for arthroplasty can reduce the risk of long-term adverse outcomes by increasing activity levels. However, uptake and ongoing positive rates of physical activity in this population are low and the impact of pre-operative behaviour counselling on exercise is not known. Method/design: The exercise and behaviour change counselling (ENHANCE) trial is a two-arm assessor-blind randomised controlled trial to assess the effectiveness of a 12-week exercise intervention designed to improve long-term physical activity and functional abilities for people awaiting arthroplasty. Participants on the waiting list for hip and knee arthroplasty are recruited from one clinical site in Australia. After collection of baseline data, participants are randomised to either an intervention or control group. The control group receive usual care, as recommended by evidence-based guidelines. The intervention group receive an individualised programme of exercises and counselling sessions. The 12-week exercise programme integrates multiple elements, including up to five in-person counselling sessions, supported by written materials. Participants are encouraged to seek social support among their friends and self-monitor their physical activity. The primary outcome is physical activity (daily step count and percentage of day spent in sedentary activities). Secondary outcomes include pain ratings, physical function, psychosocial factors and changes in clinical markers linked with potential common chronic diseases (diabetes and cardiovascular disease). All outcomes are assessed at baseline and 26 weeks later and again at 26 weeks post-surgery. Discussion: This study seeks to address a significant gap in current osteoarthritis management practice by providing evidence for the effectiveness of an exercise programme combined with behaviour counselling for adults waiting for hip and knee arthroplasty. Theory-driven evidence-based strategies that can improve an individual's exercise selfefficacy and self-management capacity could have a significant impact on the development of secondary chronic disease in this population. Information gained from this study will contribute to the evidence base on the management of adults waiting for hip and knee arthroplasty.