NCT07638020已完成不适用
Effect of a Village Doctor-delivered Exercise Therapy for Knee Osteoarthritis: a Pilot Feasibility Study
Xiangya Hospital of Central South University1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2025年7月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
研究概览
简要总结
The goal of this clinical trial is to test the feasibility of village doctor-delivered exercise therapy for knee osteoarthritis in rural China, and to preliminarily explore its treatment effects. The main questions it aims to answer are:
- Is the exercise therapy delivered by village doctors feasible with satisfactory participant adherence?
- Can this intervention produce preliminary benefits in this small pilot sample? Researchers will compare village doctor-delivered exercise therapy to usual care to see if the intervention leads to greater pain relief and functional improvement in this pilot study.
Participants will complete village-delivered exercise therapy three times a week for 12 weeks, then maintain independent exercise for another 12 weeks or receive usual care for a total of 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Although village doctors and participants cannot be blinded, outcome assessors and data analysts will remain blinded to the intervention allocation with no conflicts of interest.
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 50-80 years;
- •clinically diagnosed KOA according to the National Institute for Health and Care Excellence clinical criteria for OA (aged ≥45 years, activity-related knee pain, and either no morning joint-related stiffness or morning stiffness lasting no longer than 30 minutes);
- •knee pain occurring on most days for over three months;
- •the VAS pain score (range 0-10) ≥4;
- •Kellgren-Lawrence (KL) grade of 2-3;
- •residency in the designated village for the study duration.
排除标准
- •have received intra-articular knee injections for pain within the past six months;
- •have a history of knee surgery or have a planned knee replacement;
- •have rheumatoid arthritis or other inflammatory joint diseases;
- •possess physical or mental comorbidity that could interfere with the exercise regimen;
- •have engaged in regular or organized exercise therapy within the past six months;
- •are involved in an ongoing clinical trial
研究者
Guanghua Lei
Professor
Xiangya Hospital of Central South University
研究点 (1)
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