Lin Qiuxiang, Yu DeBiao, Lu Tianxiang, Zhang Yuping, Chen Xiaoting, Qin Jiawei, Wu Fuchun
Department of Rehabilitation Medicine, Quanzhou First Hospital Affiliated to Fujian Medical University, Quanzhou, Fujian, China.
College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, Fujian, China.
BMJ Open. 2025 Mar 5;15(3):e092689. doi: 10.1136/bmjopen-2024-092689.
Patients with knee osteoarthritis are at a higher risk of falls compared to healthy individuals, thereby increasing the likelihood of accidental injury. Resistance training is an important strategy for managing knee osteoarthritis. Although some studies suggest that blood flow restriction training combined with low-load resistance training (LL-BFRT) is a beneficial treatment approach, its effect on fall risk and balance function in patients with knee osteoarthritis remains unclear. We aim to conduct a randomised controlled trial to assess the effectiveness of combined training in reducing fall risk and improving function in patients with knee osteoarthritis.
We will conduct a single-blind pilot randomised controlled trial involving patients with knee osteoarthritis. 98 patients will be randomly assigned to either the LL-BFRT group or the low-load resistance training (LL-RT) group, with a 1:1 allocation ratio. Both groups will undergo a 4-week intervention. Follow-up assessments will be conducted at baseline, 4 weeks, 16 weeks, 28 weeks and 52 weeks. The primary outcome will be the measurement of the fall risk stability index and overall stability index using the Biodex Balance System. Secondary outcomes include the Numerical Rating Scale, the Western Ontario and McMaster Universities Osteoarthritis Index, the 30 s Chair Stand Test, proprioception testing, the Timed Up and Go Test, the Short Form-36 scores, compliance and adverse events. Intention-to-treat principles will be applied in data analysis.
This study has been approved by the Ethics Review Committee of the First Hospital of Quanzhou Affiliated Fujian Medical University (2024-K161). The results of the study will be disseminated through peer-reviewed publications.
ChiCTR2400087829.
与健康个体相比,膝骨关节炎患者跌倒风险更高,因此意外受伤的可能性增加。阻力训练是管理膝骨关节炎的一项重要策略。尽管一些研究表明,血流限制训练联合低负荷阻力训练(LL-BFRT)是一种有益的治疗方法,但其对膝骨关节炎患者跌倒风险和平衡功能的影响仍不明确。我们旨在进行一项随机对照试验,以评估联合训练在降低膝骨关节炎患者跌倒风险和改善功能方面的有效性。
我们将开展一项单盲试点随机对照试验,纳入膝骨关节炎患者。98名患者将按1:1的分配比例随机分为LL-BFRT组或低负荷阻力训练(LL-RT)组。两组均接受为期4周的干预。将在基线、4周、16周、28周和52周进行随访评估。主要结局将是使用Biodex平衡系统测量跌倒风险稳定性指数和整体稳定性指数。次要结局包括数字评定量表、西安大略和麦克马斯特大学骨关节炎指数、30秒坐立试验、本体感觉测试、计时起立行走试验、简明健康状况调查简表评分、依从性和不良事件。数据分析将采用意向性分析原则。
本研究已获得福建医科大学附属泉州第一医院伦理审查委员会批准(2024-K161)。研究结果将通过同行评审出版物进行传播。
ChiCTR2400087829。