Structured home-based exercise programme and concentric versus eccentric-based stair training programme for pain and function in knee osteoarthritis: a two-phase, double-blinded, randomised controlled trial protocol.
Kazi Md Azman Hossain, Feroz Kabir, Sharmila Jahan, Ehsanur Rahman, Kazi Md Amran Hossain, Ambika Kormoker, Md Zahirul Islam, Md Kabir Hossain, Jannatul Ferdous Rikti, Abid Hasan Khan, Sharna Yesmin Suraiya, Md Zahid Hossain
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引用次数: 0
Abstract
Introduction: Knee osteoarthritis (OA) is a leading cause of pain and disability worldwide. While exercise is crucial for managing OA, the effectiveness of a well-structured and efficient home-based, self-management exercise programme remains unclear. Therefore, this two-phase randomised controlled trial will evaluate the effectiveness of a structured home-based exercise programme (HEP) and concentric-based stair training programme versus eccentric-based stair training programme (CSTP vs ESTP) to develop an evidence-based approach for knee OA.
Methods and analysis: This study will be a participant and assessor-blinded, randomised controlled trial that will enrol 247 knee OA participants. In Phase I, there will be a 1:1 split of participants into: an HEP and a control group PI for 8 weeks. In Phase II, eligible participants from Phase I will be a 1:1:1 split into: a CSTP, an ESTP and a control group PII for another 8 weeks. The number of exercise programmes will last for 16 weeks, including a 24-week follow-up. The primary outcomes of pain intensity, pressure pain threshold and functional ability will be measured using a numeric pain rating scale, pressure algometer and Western Ontario and McMaster University Osteoarthritis Index (WOMAC). The secondary outcomes of muscle strength, range of motion, aerobic capacity and quality of life will be measured using a modified sphygmomanometer, universal goniometer, 6-minute walk test and 36-item short-form survey. All outcomes will be measured at pretest (T1), post-test (T2 and T3) and follow-up (T4).
Ethics and dissemination: All activities and exercise programmes will follow the Helsinki Declaration of 2020. The findings will be published in peer-reviewed journals and disseminated at international conferences.
膝骨关节炎(OA)是世界范围内疼痛和残疾的主要原因。虽然练习对管理OA至关重要,但结构良好和有效的以家庭为基础的自我管理练习方案的效力尚不清楚。因此,这项两期随机对照试验将评估结构化的家庭运动计划(HEP)和以同心为基础的楼梯训练计划与以偏心为基础的楼梯训练计划(CSTP vs ESTP)的有效性,以开发一种基于证据的治疗膝关节OA的方法。方法和分析:本研究将是一项参与者和评估者双盲、随机对照试验,将招募247名膝关节OA参与者。在第一阶段,参与者将以1:1的比例分成:HEP组和对照组PI组,为期8周。在第二阶段,来自第一阶段的合格参与者将按1:1:1的比例分成:CSTP组,ESTP组和对照组PII组,再持续8周。这些运动项目将持续16周,包括24周的随访。疼痛强度、压痛阈值和功能能力的主要结果将使用数字疼痛评定量表、压力测量仪和西安大略和麦克马斯特大学骨关节炎指数(WOMAC)进行测量。肌肉力量、活动范围、有氧能力和生活质量的次要指标将使用改良血压计、通用角计、6分钟步行测试和36项简短调查来测量。所有结果将在测试前(T1)、测试后(T2和T3)和随访(T4)进行测量。道德与传播:所有活动和锻炼计划都将遵循2020年赫尔辛基宣言。研究结果将发表在同行评议的期刊上,并在国际会议上传播。试验注册号:CTRI/2025/03/081574。