Effect of an exercise intervention targeting hip strengthening in patients undergoing revision total hip replacement-A study protocol for a multicenter randomized controlled trial

BackgroundLimited evidence exists regarding the effectiveness of pain relief and functional improvement in patients undergoing revision total hip replacement (THR). Furthermore, there are no clinical guidelines or consensus on optimal rehabilitation after revision THR.PurposeThe primary aim of this study was to compare the effectiveness of an exercise intervention targeting hip strengthening with standard community-based rehabilitation in patients undergoing revision THR.MethodsThis multicenter randomized controlled assessor-blinded trial will be conducted at eight hospitals and multiple municipality rehabilitation centers in Denmark. A total of 84 patients undergoing revision THR are estimated to be allocated to either an exercise intervention targeting hip strengthening (NEMEX-STR) or standard community-based rehabilitation (Usual care). Recruitment was initiated in November 2022 and is expected to be completed by June 2024. The primary outcome is change in functional performance measured by the 30 s chair stand test, from baseline to 4 months after the start of intervention. Secondary outcomes include hip disability and osteoarthritis outcome score; 40 m fast-paced walk test; 9-step timed stair climb test; leg extensor muscle power; global perceived effect; and adverse events. Other outcomes include The International Physical Activity Questionnaires, pain intensity, and European quality of life-5 dimensions. An intention-to-treat approach will be used for analyzing changes in primary and secondary outcome measures. The trial was approved by the Central Denmark Region Committees on Health Research Ethics (Journal No 1-10-72-134-22) and registered on the Central Denmark Regions' internal list of research projects (Journal No 1-16-02-285-22).DiscussionTo our knowledge, this study is the first to explore different rehabilitation programs after revision THR through a randomized controlled trial. The results will provide clinically relevant evidence for optimal rehabilitation after revision THR for improving functional performance, physical function, and quality of life, with great importance for patients, relatives, physiotherapists, and decision-makers.ClinicalTrial.govNCT05657054.