Effectiveness of gamification in knee replacement rehabilitation: Protocol for a randomized controlled trial (BEE-RCT) with a qualitative approach (Preprint)

BACKGROUND Exergames can provide encouraging exercise options. Currently, there is limited evidence regarding home-based exergaming in the post-operative phase of total knee replacement (TKR). OBJECTIVE This study aimed to investigate the effects of a 4-month post-operative home-based exergame intervention with an 8-month follow-up on physical functioning and symptoms among older persons undergoing TKR compared with home exercise using a standard protocol. Additionally, a concurrent embedded design of a mixed-methods study was used by including a qualitative component within a quantitative study of exergame effects. METHODS This was a dual-center, non-blinded, two-arm, parallel-group, randomized controlled trial with an embedded qualitative approach. One hundred patients who underwent their first unilateral TKR (age 60–75 years) were aimed to recruite. Participants were randomized to exergames or standard home exercise arms. Participants followed a progressive custom-made exergame program independently at their homes daily for four months. The primary outcomes at four months were function and pain related to the knee using the Oxford knee score questionnaire and mobility by the Timed Up and Go test. Other outcomes, in addition to physical function, symptoms, and disability, were game user experience, exercise adherence, physical activity, and satisfaction with the operated knee. Assessments were performed at the preoperative baseline and the 2nd, 4th, and 12th months post-operatively. Exergame adherence from game computers and self-reported standard exercise was followed for four months of intervention, and physical activity for 12 months using a structured diary. Qualitative data on the patients' perspectives on rehabilitation and exergames were collected through laddering interviews at 4 and 12 months. RESULTS The BEE-RCT was funded in 2018. Data collection started in 2019 and was completed in January 2022. The Covid-19 pandemic has caused an unavoidable situation in the study for recruitment, data collection, and statistical analysis. As of November 2020, 52 participants had been enrolled in the study. Primary results are expected to be published in spring 2022. CONCLUSIONS Our trial provides new knowledge on the effects of post-operative exergame intervention among older patients with TKR. Our project provides a new understanding of gamified post-operative rehabilitation, home exercise adherence, physical function, and physical activity in older adults undergoing TKR. CLINICALTRIAL ClinicalTrials.gov Identifier: NCT03717727