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结构化家庭锻炼计划以及基于向心与离心的楼梯训练计划对膝关节骨关节炎疼痛和功能的影响:一项两阶段、双盲、随机对照试验方案

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.

作者信息

Hossain Kazi Md Azman, Kabir Feroz, Jahan Sharmila, Rahman Ehsanur, Hossain Kazi Md Amran, Kormoker Ambika, Islam Md Zahirul, Hossain Md Kabir, Rikti Jannatul Ferdous, Khan Abid Hasan, Suraiya Sharna Yesmin, Hossain Md Zahid

机构信息

Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore, Bangladesh.

Department of Physiotherapy, BRB Hospitals Limited, Dhaka, Bangladesh.

出版信息

BMJ Open Sport Exerc Med. 2025 Apr 3;11(2):e002577. doi: 10.1136/bmjsem-2025-002577. eCollection 2025.

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 P 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 P 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 (T), post-test (T and T) and follow-up (T).

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.

TRIAL REGISTRATION NUMBER

CTRI/2025/03/081574.

摘要

引言

膝关节骨关节炎(OA)是全球疼痛和残疾的主要原因。虽然运动对OA的管理至关重要,但精心设计且高效的家庭自我管理运动计划的有效性仍不明确。因此,这项两阶段随机对照试验将评估结构化家庭运动计划(HEP)以及基于向心的楼梯训练计划与基于离心的楼梯训练计划(CSTP与ESTP)的有效性,以开发一种基于证据的膝关节OA治疗方法。

方法与分析

本研究将是一项参与者和评估者双盲的随机对照试验,将招募247名膝关节OA参与者。在第一阶段,参与者将按1:1比例分为:HEP组和对照组P,为期8周。在第二阶段,第一阶段符合条件的参与者将按1:1:1比例分为:CSTP组、ESTP组和对照组P,再进行8周。运动计划为期16周,包括24周的随访。疼痛强度、压力痛阈和功能能力的主要结局将使用数字疼痛评分量表、压力痛觉计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、有氧运动能力和生活质量的次要结局将使用改良血压计、通用角度计、6分钟步行试验和36项简短调查问卷进行测量。所有结局将在预测试(T)、后测试(T和T)和随访(T)时进行测量。

伦理与传播

所有活动和运动计划将遵循2020年《赫尔辛基宣言》。研究结果将发表在同行评审期刊上,并在国际会议上传播。

试验注册号

CTRI/2025/03/081574。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/21f3/11969612/5c32ff3e8940/bmjsem-11-2-g001.jpg

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