The effect of transtheoretical model-lead intervention for knee osteoarthritis in older adults: A cluster randomized trial

Background: Knee osteoarthritis (KOA) is a common joint disease in people over 60 years old. Exercise therapy is one of the most effective non-pharmacological treatments for KOA, but low exercise adherence needs to be improved. The present study aimed to evaluate the effect of the transtheoretical model-lead home exercise intervention (TTM-HEI) program on exercise adherence, KOA symptoms, and knee function in older adults with KOA. Methods: A two-arm, superiority, assessor-blinded, cluster randomized trial was conducted. Community-dwelling older adults with KOA were recruited from 14 community centers in Beijing, China, via print and social media advertisements from April to October 2018. The present study lasted 48 weeks, with an intervention duration of 0-24 weeks and follow-up time of 24-48 weeks. The intervention was a two-stage and 24-week TTM-based exercise program, and the control group underwent a same-length exercise program guidance without any exercise adherence interventions. The primary outcome was exercise adherence to the prescribed home exercise program and was measured using an 11-point numerical (0 = not at all through and 10 = completely as instructed) self-rating scale at weeks 4, 12, 24, 36, and 48 after the program started. KOA symptoms (pain intensity and joint stiffness) were measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and knee function (lower limb muscle strength and balance) was measured using the Five-Times-Sit-to-Stand Test (FTSST) and the Timed Up and Go Test (TUG) at baseline, week 24, and week 48. Latent growth model (GLM), repeated measures ANOVA, and independent t test were the main statistical tests used. Results: A total of 189 older adults (intervention group: n = 103, control group: n = 86) were enrolled. Differences of any outcome measures at baseline were not significant between groups. The growth rate of exercise adherence in the intervention group increased 2.175 units compared with that in the control group (unstandardized coefficient of slope on group B2 = 2.175, p < 0.001), and the intervention program maintained participants' exercise adherence with 5.56 (SD = 1.00) compared with 3.16 (SD = 1.31) in the control group at week 48. In addition, the TTM-HEI program showed significant effects on relieving KOA symptoms and improving knee function. Conclusion: Over time, TTM-HEI could improve participants' exercise adherence, KOA symptoms, and knee function. Trial registration: This study was approved by the ethics committee (IRB00001052-17066) in July 2017 and was registered at the Chinese Clinical Trial Registry (website: www.chictr.org.cn, registry number: ChiCTR1800015458).