NCT07312396尚未招募不适用
An Exploratory Clinical Study on the Protective Effect of Cycling on the Ankle Joint in Gout
Zhu Xiaoxia0 个研究点目标入组 90 人开始时间: 2026年1月1日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 主要终点
- The frequency of gout attacks
研究概览
简要总结
This study divided the enrolled gout patients into a jogging group and a cycling group to investigate 1）the effectiveness of cycling intervention in reducing the recurrence risk of gouty ankle arthritis compared with jogging. 2) To clarify the influence of different exercise patterns on the ultrasonic manifestations of gouty ankle arthritis; 3) Clarify the impact of different exercise methods on the blood uric acid levels of gout patients;
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •meets the diagnostic criteria for gout of the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) in 2015
- •There have been two histories of gout attacks on either side of the ankle joint in the past six months
- •Ultrasound examination within the past 6 months indicated that either ankle joint had characteristic ultrasound manifestations (double-track sign, and/or hyperechoic aggregates, and/or tophi, and/or bone destruction)
- •Those who have had an interval of at least 4 weeks since the most recent acute gout attack
- •If the patient is undergoing uric acid-lowering drug treatment, the drug dosage must remain stable for more than 4 weeks. During the study period, the uric acid-lowering drug regimen or dosage will not be adjusted
- •For women who have the potential to become pregnant, a pregnancy test must be negative, they must not be in the lactation period, and it must be confirmed that they are receiving contraception approved by the researcher and agree to maintain this contraceptive measure throughout the study process
- •Those who were informed of this study and signed the informed consent form
排除标准
- •Those who have received intra-articular injections of corticosteroids during an attack within the past three months; Those who have taken colchicine, NSAIDs, glucocorticoids in the past two weeks, or those who need to maintain anti-inflammatory drug treatment for a long time during the follow-up period
- •Joint trauma or other types of arthritis
- •There is a history of joint prosthesis or joint surgery
- •Those who have had acute gout attacks within 4 weeks
- •Patients with secondary gout caused by kidney diseases, blood disorders, or taking certain medications, radiotherapy and chemotherapy for tumors, etc
- •Those with severe and unstable cardiovascular and cerebrovascular diseases (such as unstable angina pectoris, coronary angiogenesis, cerebral angiogenesis, transient ischemic attack, congestive heart failure, etc.) and other diseases that researchers have determined to be acute and difficult to control
研究组 & 干预措施
Control Group
Active Comparator
干预措施: Urate-lowering therapy (ULT) (Drug)
Control Group
Active Comparator
干预措施: Jogging (Behavioral)
Experimental Group
Experimental
干预措施: Urate-lowering therapy (ULT) (Drug)
Experimental Group
Experimental
干预措施: Cycling (Behavioral)
结局指标
主要结局
The frequency of gout attacks
时间窗: From enrollment to the end of treatment at 24 weeks
次要结局
- blood uric acid(From enrollment to the end of treatment at 24 weeks)
- Gouty arthritis joint pain score(From enrollment to the end of treatment at 24 weeks)
- Ankle joint magnetic resonance(From enrollment to the end of treatment at 24 weeks)
- Ankle joint ultrasound(From enrollment to the end of treatment at 24 weeks)
研究者
Zhu Xiaoxia
Associate Chief Physician
Huashan Hospital
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