Effects of Strengthening‐Based Home Exercise Program on Pain and Function in Knee Osteoarthritis: Phase I Results of a Two‐Phase Randomized Controlled Trial

ABSTRACT Background and Aims Knee osteoarthritis (KOA) is a major cause of pain, disability, and reduced quality of life worldwide. Exercise therapy is widely recommended as a first‐line non‐pharmacological treatment; however, evidence on a strengthening‐based home exercise program (SHEP) remains limited. This study aimed to investigate the effects of 8 weeks SHEP intervention on pain and function in KOA. Methods This randomized controlled trial involved 247 KOA participants aged 45–70, who were randomly assigned to the experimental group receiving SHEP with lifestyle advice, or the control group receiving pain medication with lifestyle advice for 8 weeks. Primary outcomes included pain intensity measured using the Numeric Pain Rating Scale (NPRS), pressure pain threshold (PPT) assessed with an algometer, and functional ability measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Secondary outcomes included muscle strength, range of motion (ROM), Six‐Minute Walk Test (6MWT), and quality‐of‐life measures. Outcomes were assessed at baseline and after 8 weeks. Results After 8 weeks, the experimental group demonstrated significantly greater improvements than the control group ( p < 0.001). Pain intensity was reduced (mean difference [MD] = –1.95; 95% CI: –2.28 to –1.62), PPT increased (MD = 0.46; 95% CI: 0.32–0.60), and WOMAC total score improved (MD = –12.62; 95% CI: –14.37 to –10.86). Significant between‐group improvements were also observed in muscle strength, ROM, 6MWT, and quality‐of‐life scores ( p < 0.001). No serious adverse events were reported throughout the trial. Conclusion Eight weeks SHEP intervention was associated with significant improvements in pain, physical function, and quality of life in individuals with KOA. This intervention appeared to be feasible and was generally well tolerated by participants, supporting its potential as a sustainable rehabilitation strategy, particularly in resource‐limited healthcare settings. Trial Registration: ID: CTRI/2025/03/081575.