Table1_Different intensities of aerobic training for patients with type 2 diabetes mellitus and knee osteoarthritis: a randomized controlled trial.doc

ObjectiveThe purpose of this study was to compare different intensities of aerobic exercise for patients with knee osteoarthritis (KOA) and type 2 diabetes mellitus (T2DM) in terms of glycemic control, pain relief, and functional outcomes.MethodsA prospective randomized open-label parallel multicenter clinical trial conducted at two hospitals in Shanghai and Sichuan that included 228 patients with type 2 diabetes mellitus (T2DM) and knee osteoarthritis (KOA). Enrollment occurred between January 2021 and February 2023, and follow-up was completed in September 2023. Participants were randomized to threshold training/high-intensive stationary cycling training (n=76), intensive endurance/moderate-intensive stationary cycling training (n=77), and regular rehabilitation programs (n=75). The primary outcome at the 6-month follow-up was the HbA1c level. Key secondary outcomes included the Knee Injury and Osteoarthritis Outcome Score (KOOS) subscale of pain and quality of life.ResultsOf 228 patients, 212 (93%) completed the trial. The mean adjusted (sex, baseline BMI, and baseline outcome measures) HbA1c level at the 6-month follow-up decreased significantly in the high-intensive training group compared with other groups (high-intensity group vs. control group; difference, 0.51%, 95% confidence interval, 0.05% to 1.15%). Mean KOOS subscales of pain and quality of life were statistically significantly different between the control group and moderate-intensity or high-intensity groups, but no statistical differences were noted between the different intensities of aerobic exercise. Patients in all groups achieved a greater reduction in BMI but no significant differences were observed between groups.ConclusionIn KOA and T2DM patients, high-intensity stationary cycling can significantly improve glycemic control compared with moderate-intensity and regular rehabilitation programs. However, high-intensity stationary cycling does not exert a superior effect on pain relief and functional improvement for KOA compared with moderate-intensity and regular rehabilitation programs.

本研究旨在对比不同强度的有氧运动对膝关节骨关节炎（KOA）和2型糖尿病（T2DM）患者的血糖控制、疼痛缓解及功能结果的影响。研究方法为在上海和四川的两家医院进行的开放标签平行多中心前瞻性随机临床试验，纳入了228名患有2型糖尿病（T2DM）和膝关节骨关节炎（KOA）的患者。招募时间介于2021年1月至2023年2月，随访于2023年9月完成。参与者被随机分配至阈值训练/高强度固定自行车训练组（n=76）、高强度/中强度固定自行车训练组（n=77）以及常规康复计划组（n=75）。6个月随访的主要结果为HbA1c水平。关键次要结果包括膝关节损伤与骨关节炎结果评分（KOOS）的疼痛和生活质量子量表。结果显示，在228名患者中，212名（93%）完成了试验。与其它组相比，高强度训练组在6个月随访时的平均调整后（性别、基线BMI和基线结果测量）HbA1c水平显著降低（高强度组与控制组；差异，0.51%，95%置信区间，0.05%至1.15%）。疼痛和生活质量子量表的平均KOOS评分在控制组与中强度或高强度组之间存在统计学上的显著差异，但不同强度的有氧运动之间没有观察到统计学差异。所有组别的患者在BMI方面均实现了更大的降低，但组间未见显著差异。结论：在KOA和T2DM患者中，与中强度和常规康复计划相比，高强度固定自行车训练可以显著改善血糖控制，但在疼痛缓解和功能改善方面，高强度固定自行车训练并不优于中强度和常规康复计划。