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

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. This randomized controlled trial will enroll 96 participants randomized 1:1 to hip-focused core stability training or celecoxib. The intervention group will receive a 6-week, low-to-moderate intensity trunk–pelvic–hip neuromuscular control and stabilization program, followed by a home maintenance program until 12 months. The control group will receive celecoxib 100 mg twice daily for 6 weeks plus standardized usual-care education, with matched neutral check-ins to balance attention. All participants will undergo 7-day ActiGraph monitoring at baseline, week 4, week 8, month 6, and month 12. The primary outcome is WOMAC score at 12 months. Secondary outcomes include SF-36, VAS knee pain, Patient Global Assessment, OMERACT-OARSI response, physical function, cardiovascular indices, biomarkers, and safety outcomes. Analyses will use mixed models, multiple-imputation sensitivity analyses for missing data, Holm correction for secondary outcomes, and Benjamini-Hochberg adjustment for exploratory biomarker analyses. 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. ChiCTR2400092840 (Registration Date: Nov 25, 2024).