Study protocol for a randomized controlled trial of hip-focused core stability training versus celecoxib in older adults with knee osteoarthritis and coronary artery disease

Introduction Studies have suggested that exercise rehabilitation is effective in reducing pain and improving functionality in older patients with coronary artery disease and knee osteoarthritis. Core stability training has been shown to enhance trunk and pelvis stability, which, in turn, can reduce kinematic abnormalities in the lower limbs during exercise. Core stability training has the potential to serve as an exercise modality for treating knee osteoarthritis. However, few studies have investigated the efficacy of core stability training in patients with both knee osteoarthritis and coronary artery disease, and its mechanism of action remains unclear, warranting further investigation. The aim of this randomized clinical trial is to examine the effects of a therapeutic program focused on hip-centric core stability compared to celecoxib on clinical outcomes in older patients with coronary artery disease and knee osteoarthritis. Methods and analysis This randomized controlled trial will involve 96 participants, with 48 participants randomized to the intervention group, which will receive hip-focused core stability strategies, and 48 participants randomized to the control group, which will receive celecoxib. The intervention protocol will consist of both treatment and exercise components, including functional hip and core stability exercises. These exercises will target muscles in the anterior, posterior, and lateral trunk to improve neuromuscular control and dynamic spinal stability. The goal is to enhance strength, endurance, and control of the hip muscles while performing functional tasks, such as squatting and stepping. The intervention will comprise 24 sessions, conducted four times a week over the course of six weeks. The control group will receive celecoxib (100 mg twice a day) for a total of six weeks. The primary outcome will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Secondary outcomes will include the SF-36 scale to assess quality of life and the total effective rate measured by the Visual Analog Scale (VAS). Blood samples will be analyzed to evaluate relevant biomarkers. Post hoc sensitivity analyses will be conducted for missing data using multiple imputation, incorporating covariates associated with baseline and missing values at 12 months using the same mixed-model approach. Outcome analyses will be reported as least squares means with 95% confidence intervals. The analysis of categorical outcomes for dichotomized variables at one year will be performed using two-by-two contingency tables, and relative risks and relative risk reductions will be calculated. Ethics and dissemination This study will involve human participants and has been approved by the Ethics Committee of Wuxi Second People's Hospital, affiliated with Jiangnan University. Participants will provide informed consent prior to their participation in the study. Researchers will communicate the trial results to participants and healthcare professionals through scientific databases, social media, publications, and conferences. Trial registration number ChiCTR2400092840 (Registration Date: Nov 25, 2024)