ChiCTR2600122259 版本V1.1 版本创建时间2026/04/17 11:31:21 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2600122259 

最近更新日期：

Date of Last Refreshed on：

2026-04-10 16:07:55 

注册时间：

Date of Registration：

2026-04-10 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

一项评价短期结构化运动干预及后续行为维持对延缓非透析慢性肾脏病进展效果的随机对照研究

Public title：

A Randomized Controlled Trial Evaluating the Effects of a Short-Term Structured Exercise Intervention and Subsequent Behavior Maintenance on Delaying Disease Progression in Non-Dialysis Chronic Kidney Disease Patients

注册题目简写：

English Acronym：

研究课题的正式科学名称：

一项评价短期结构化运动干预及后续行为维持对延缓非透析慢性肾脏病进展效果的随机对照研究

Scientific title：

A Randomized Controlled Trial Evaluating the Effects of a Short-Term Structured Exercise Intervention and Subsequent Behavior Maintenance on Delaying Disease Progression in Non-Dialysis Chronic Kidney Disease Patients

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

唐莼 

研究负责人：

唐莼 

Applicant：

Tang Chun 

Study leader：

Tang Chun 

申请注册联系人电话：

Applicant telephone：

+86 755 81206806

研究负责人电话：

Study leader's telephone：

+86 755 81206806

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

tangch28@mail.sysu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

tangchunly@163.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

广东省深圳市光明区新湖街道圳园路628号

研究负责人通讯地址：

广东省深圳市光明区新湖街道圳园路628号

Applicant address：

No.628, Zhenyuan Rd, Guangming (New) Dist., Shenzhen, China, 518107

Study leader's address：

No628 Zhenyuan Road Guangming New District Shenzhen 518107 China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

中山大学附属第七医院肾脏病中心

Applicant's institution：

Center of Nephrology and Urology, The Seventh Affiliated Hospital, Sun Yat-sen University

研究负责人所在单位：

中山大学附属第七医院

Affiliation of the Leader：

The?Seventh?Affiliated?Hospital?Sun?Yat-sen?University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

KY-2026-022-01

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

中山大学附属第七医院科研伦理委员会

Name of the ethic committee：

Ethics approval Certificate of the Medical Ethics Committee of the Seventh Affiliated Hospital, Sun Yat-sen University

伦理委员会批准日期：

Date of approved by ethic committee：

2026-01-26 00:00:00

伦理委员会联系人：

唐燕

Contact Name of the ethic committee：

Yan Tang

伦理委员会联系地址：

广东省深圳市光明区新湖街道圳园路628号

Contact Address of the ethic committee：

No628 Zhenyuan Road Guangming New District Shenzhen 518107 China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 755 81207260

伦理委员会联系人邮箱：

Contact email of the ethic committee：

tangyan2@sysush.com

研究实施负责（组长）单位：

中山大学附属第七医院

Primary sponsor：

The?Seventh?Affiliated?Hospital?Sun?Yat-sen?University

研究实施负责（组长）单位地址：

广东省深圳市光明区新湖街道圳园路628号

Primary sponsor's address：

No628 Zhenyuan Road Guangming New District Shenzhen 518107 China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广东省

市(区县)：

Country：

China

Province：

Guangdong

City：

单位(医院)：

中山大学附属第七医院

具体地址：

广东省深圳市光明区新湖街道圳园路628号

Institution
hospital：

The?Seventh?Affiliated?Hospital?Sun?Yat-sen?University

Address：

No628 Zhenyuan Road Guangming New District Shenzhen 518107 China

经费或物资来源：

基础研究（面上项目）

Source(s) of funding：

Shenzhen Municipal Science and Technology Innovation Commission

Target disease：

chronic kidney disease (CKD)

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本研究拟开展一项前瞻性、随机对照、优效性试验，旨在系统评估为期2个月的以中等强度有氧运动为核心的结构化运动干预与4个月自主维持期对非透析3-4期CKD患者肾功能、机体功能状态及系列临床相关指标的效应。 主要目标为：通过比较运动干预组与常规护理对照组在基线与6个月时的eGFR变化值，验证该结构化运动方案在延缓非透析CKD患者肾功能进展方面的优效性。 次要目标包括： 1.评估干预对患者健康相关生活质量（采用肾脏病生活质量简表KDQOL-36评定）的影响； 2.评价干预对患者运动耐力（以6分钟步行距离为指标）的改善程度； 3.分析干预对心血管/肾脏复合终点指标的影响，涵盖慢性肾脏病-矿物质和骨异常（CKD-Mineral and Bone Disorder, CKD-MBD）相关指标、营养状态及心血管结构与功能参数； 4.探究干预对炎症、氧化应激及代谢相关生物标志物的调控作用； 5.综合评价该干预方案的临床安全性、实施可行性及患者依从性。  

Objectives of Study：

This study is designed as a prospective, randomized controlled, superiority trial aimed at systematically evaluating the effects of a 2-month structured exercise intervention centered on moderate-intensity aerobic exercise, followed by a 4-month self-maintenance period, on renal function, physical functional status, and a series of clinically relevant indicators in patients with non-dialysis chronic kidney disease (CKD) stages 3–4. The primary objective is to verify the superiority of this structured exercise program in slowing the progression of renal function in non-dialysis CKD patients by comparing the change in estimated glomerular filtration rate (eGFR) from baseline to 6 months between the exercise intervention group and the usual care control group. Secondary objectives include: 1. assessing the impact of the intervention on health-related quality of life, as measured by the Kidney Disease Quality of Life Short Form (KDQOL-36); 2. evaluating the degree of improvement in exercise tolerance, indicated by the 6-minute walking distance; 3. analyzing the effects of the intervention on cardiovascular/renal composite endpoint indicators, covering chronic kidney disease–mineral and bone disorder (CKD-MBD)-related parameters, nutritional status, and cardiovascular structure and function measures; 4. investigating the regulatory effects of the intervention on inflammatory, oxidative stress, and metabolism-related biomarkers; 5. Comprehensively evaluate the clinical safety, feasibility of implementation, and patient compliance of the intervention plan.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.年龄介于18至75周岁之间； 2.处于非透析状态，且符合KDIGO 2021指南中CKD的诊断标准，即eGFR < 60 mL/min/1.73 m2持续超过3个月，或存在其他肾损伤标志物异常;且15 mL/min/1.73 m2

Inclusion criteria

1. Aged between 18 and 75 years; 2. Being in a non-dialysis state and meeting the diagnostic criteria for CKD according to the KDIGO 2021 guidelines, i.e., eGFR < 60 mL/min/1.73 m2 sustained for over 3 months, or presence of other markers indicative of kidney damage; and with 15 mL/min/1.73 m2 < eGFR < 60 mL/min/1.73 m2, corresponding to CKD stages 3-4; 3. Clinically stable, defined as having an eGFR fluctuation within 15% and a urinary albumin-to-creatinine ratio fluctuation within 20% during the 3 months prior to enrollment, with no history of acute exacerbation; 4. Possessing basic physical mobility, with a 6-minute walking distance exceeding 100 meters, and without severe motor dysfunction; 5. No history of regular high-intensity exercise in the preceding 3 months, i.e., cumulative moderate-intensity exercise of less than 60 minutes per week; 6. Voluntarily signing the informed consent form and committing to complete all follow-ups and assessments specified by the study protocol.

排除标准：

1.合并严重且未控制的伴随疾病，例如：经两种及以上降压药物治疗后，收缩压仍不低于160 mmHg或舒张压不低于100 mmHg；或糖化血红蛋白不低于9.0%的未控制糖尿病；或Child-Pugh分级为B级及以上的严重肝功能不全； 2.存在药物或酒精依赖，定义为每周酒精摄入量不低于140克； 3.近3个月内曾发生心肌梗死、脑卒中或因心力衰竭住院等重大心血管事件； 4.妊娠或哺乳期女性； 5.伴有不稳定性心血管疾病，如严重心律失常或心绞痛频繁发作；或其他运动禁忌症，如急性感染、严重骨质疏松伴骨折风险； 6.因偏瘫、截肢等原因导致严重运动功能受限； 7.存在痴呆、精神分裂症等认知或精神障碍，以致无法理解和配合研究流程； 8.计划在未来6个月内接受透析治疗或肾移植手术； 9.目前正在参与其他干预性临床研究。

Exclusion criteria：

1. Presence of severe and uncontrolled comorbid conditions, such as systolic blood pressure persistently ≥160 mmHg or diastolic blood pressure persistently ≥100 mmHg despite treatment with two or more antihypertensive agents; or uncontrolled diabetes with a glycated hemoglobin (HbA1c) level ≥9.0%; or severe hepatic insufficiency classified as Child-Pugh grade B or higher; 2. History of substance or alcohol dependence, defined as an alcohol intake of ≥140 grams per week; 3. Occurrence of a major cardiovascular event within the past 3 months, such as myocardial infarction, stroke, or hospitalization for heart failure; 4. Females who are pregnant or lactating; 5. Presence of unstable cardiovascular diseases, such as severe arrhythmia or frequent angina attacks; or other contraindications to exercise, such as acute infection or severe osteoporosis with high fracture risk; 6. Severe motor impairment due to conditions such as hemiplegia or amputation; 7. Cognitive or psychiatric disorders, such as dementia or schizophrenia, that preclude understanding of or cooperation with the study procedures; 8. Planned initiation of dialysis therapy or kidney transplantation within the next 6 months; 9. Current participation in another interventional clinical study.

研究实施时间：

Study execute time：

从 From 2026-04-01 00:00:00至 To 2027-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-04-10 00:00:00 至 To 2026-06-30 00:00:00  

干预措施：

Interventions：

组别：

常规护理对照组

样本量：

75

Group：

Usual Care Control Group

Sample size：

干预措施：

常规护理与匹配频率的健康教育

干预措施代码：

Intervention：

Routine Care and Health Education at Matching Frequency

Intervention code：

组别：

运动干预组

样本量：

75

Group：

Exercise Intervention Group

Sample size：

干预措施：

基于有氧运动的结构化运动干预及行为维持方案

干预措施代码：

Intervention：

Structured Aerobic Exercise Intervention with Behavioral Maintenance Program

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东省 

市(区县)：

  

Country：

China 

Province：

Guangdong 

City：

 

单位(医院)：

中山大学附属第七医院 

单位级别：

三级甲等 

Institution
hospital：

The?Seventh?Affiliated?Hospital?Sun?Yat-sen?University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

运动耐力

指标类型：

次要指标

Outcome：

Exercise Capacity

Type：

Secondary indicator

测量时间点：

基线、干预后2个月、干预后6个月

测量方法：

通过6分钟步行距离测试评定

Measure time point of outcome：

Baseline, 2 months post-intervention, and 6 months post-intervention

Measure method：

Assessed by the 6-Minute Walk Distance Test

指标中文名：

健康相关生活质量

指标类型：

次要指标

Outcome：

Health-Related Quality of Life (HRQoL)

Type：

Secondary indicator

测量时间点：

基线、干预后2个月、干预后6个月

测量方法：

采用KDQOL-36量表评估

Measure time point of outcome：

Baseline, 2 months post-intervention, and 6 months post-intervention

Measure method：

Assessments were performed using the Kidney Disease Quality of Life-36 (KDQOL-36) questionnaire.

指标中文名：

氧化应激标志物

指标类型：

次要指标

Outcome：

Oxidative Stress Biomarkers

Type：

Secondary indicator

测量时间点：

基线、干预后2个月、干预后6个月

测量方法：

采集受试者空腹静脉血，置于含EDTA的试管中，立即冰浴并低温离心分离血浆，分装后于-80°C冷冻保存。使用液相色谱-串联质谱法（金标准）进行分析。通过：批量检测以控制变异，排除采样前一周内的非甾体抗炎药使用及剧烈运动干扰。所有操作需遵循标准化实验流程。进行质控。

Measure time point of outcome：

Baseline, 2 months post-intervention, and 6 months post-intervention

Measure method：

Fasting venous blood was collected in EDTA-containing tubes, immediately placed on ice, and centrifuged at low temperature to isolate plasma. After aliquoting, samples were stored at -80°C. Analysis was performed using liquid chromatography-tandem mass spectrometry (LC-MS/MS; the gold standard). Batch analysis was conducted to control variability, with exclusion of NSAID use and strenuous exercise within one week prior to sampling. All procedures followed a standardized protocol and included qua

指标中文名：

炎症标志物

指标类型：

次要指标

Outcome：

Inflammatory Biomarkers

Type：

Secondary indicator

测量时间点：

基线、干预后2个月、干预后6个月

测量方法：

指标包含高敏C反应蛋白、白细胞介素-6及肿瘤坏死因子-α，标准化测量方法如下： 1. 高敏C反应蛋白：采集静脉血（建议空腹），分离血清或血浆，使用颗粒增强免疫比浊法等高灵敏度检测方法进行测定。 2. 白细胞介素-6：采集静脉血，按要求及时分离并冷冻保存血清或血浆样本，采用电化学发光法或高灵敏度ELISA等标准化免疫分析方法测定。 3. 肿瘤坏死因子-α：采集静脉血，按要求及时分离并冷冻保存血清或血

Measure time point of outcome：

Baseline, 2 months post-intervention, and 6 months post-intervention

Measure method：

The biomarkers hs-CRP, IL-6, and TNF-α were measured using standardized methods: hs-CRP in serum/plasma (fasting preferred) via high-sensitivity immunoturbidimetry; IL-6 and TNF-α in promptly separated and frozen serum/plasma via immunoassays such as electrochemiluminescence or ELISA.

指标中文名：

估算肾小球滤过率（eGFR）

指标类型：

主要指标

Outcome：

estimated Glomerular Filtration Rate (eGFR)

Type：

Primary indicator

测量时间点：

基线、干预后2个月、干预后6个月

测量方法：

eGFR数值系基于患者在医院内通过标准采血流程获取的静脉血标本，经实验室标准化检测肾功能五项，并严格依据2021CKD-EPI公式计算得出。

Measure time point of outcome：

Baseline, 2 months post-intervention, and 6 months post-intervention

Measure method：

The eGFR values were derived from venous blood samples collected from patients via standard phlebotomy procedures in the hospital setting. Renal function was assessed using a standardized panel of five biomarkers, and eGFR was calculated strictly in accordance with the 2021 CKD-EPI equation.

指标中文名：

营养状态指标

指标类型：

次要指标

Outcome：

Nutritional Status Assessment Parameters

Type：

Secondary indicator

测量时间点：

基线、干预后2个月、干预后6个月

测量方法：

通过溴甲酚绿法标准化测定血清白蛋白，以统一规范的试剂标准化、校准与定标、全程质量控制，确保结果准确、可比。

Measure time point of outcome：

Baseline, 2 months post-intervention, and 6 months post-intervention

Measure method：

Serum albumin is measured using a standardized bromocresol green method, withuniform reagent standardization, calibration, and full-process quality control to ensureaccurate and comparable results.

指标中文名：

心血管结构与功能指标

指标类型：

次要指标

Outcome：

Cardiovascular Structure and Function Parameters

Type：

Secondary indicator

测量时间点：

基线、干预后2个月、干预后6个月

测量方法：

进行血流介导的血管舒张功能、颈动脉-股动脉脉搏波传导速度、诊室血压及超声心动图参数的测量：FMD：规范操作下测量肱动脉反应性充血前后的内径变化，计算最大舒张百分比；cfPWV：同步测量颈动脉-股动脉脉搏波传导时间与体表距离，计算PWV；诊室血压：标准静息后，使用合格设备测量并取平均值；超声心动图：依据指南标准切面测量核心心功能参数。

Measure time point of outcome：

Baseline, 2 months post-intervention, and 6 months post-intervention

Measure method：

Flow-mediated dilation (FMD), carotid-femoral pulse wave velocity (cfPWV), office blood pressure, and echocardiographic parameters were measured. FMD: Brachial artery diameter change after reactive hyperemia was measured to calculate maximum dilation percentage. cfPWV: Pulse wave transit time and surface distance were measured to calculate PWV. Office blood pressure: Average of readings taken after rest with a validated device. Echocardiography: Key parameters were measured in standard views per

指标中文名：

CKD-MBD相关指标

指标类型：

次要指标

Outcome：

CKD-MBD–related parameters

Type：

Secondary indicator

测量时间点：

基线、干预后2个月、干预后6个月

测量方法：

本研究通过标准化实验室检测评估CKD-MBD状态，核心指标包括经白蛋白校正的血清总钙、血清无机磷、电化学发光法测定的全段甲状旁腺激素（iPTH）及化学发光免疫法测定的25-羟维生素D。所有检测均严格遵循标准操作规程并通过内部质控，其判读与整合依据KDIGO临床实践指南进行。

Measure time point of outcome：

Baseline, 2 months post-intervention, and 6 months post-intervention

Measure method：

In this study, CKD-MBD status was evaluated using standardized laboratory assays. The core parameters included albumin-adjusted serum total calcium, serum inorganic phosphorus, intact parathyroid hormone (iPTH) measured by electrochemiluminescence assay, and 25-hydroxyvitamin D determined by chemiluminescent immunoassay. All tests were performed in strict accordance with standard operating procedures and validated by internal quality control. Interpretation and integration of these parameters we

指标中文名：

血液生化与代谢指标

指标类型：

次要指标

Outcome：

Blood Biochemical and Metabolic Parameters

Type：

Secondary indicator

测量时间点：

基线、干预后2个月、干预后6个月

测量方法：

进行血糖、糖化血红蛋白及血脂全套的测量：1. 血糖：采集空腹8-12小时后的静脉血，使用标准实验室葡萄糖氧化酶法测定血浆葡萄糖浓度。2. 糖化血红蛋白：采集静脉血（无需空腹），采用经认证的高效液相色谱法等标准化方法进行测定。3. 血脂全套：采集空腹12小时以上的静脉血，测定项目至少包括总胆固醇、甘油三酯、高密度脂蛋白胆固醇和低密度脂蛋白胆固醇。推荐使用酶法等标准生化分析。

Measure time point of outcome：

Baseline, 2 months post-intervention, and 6 months post-intervention

Measure method：

Blood glucose, HbA1c and complete lipid profile testing: Glucose: Venous blood collected after 8–12h fasting; plasma glucose determined by standard glucose oxidase method. HbA1c: Non-fasting venous blood; measured by certified standardized methods (e.g., HPLC). Lipid profile: Venous blood collected after ≥12h fasting; covers TC, TG, HDL-C, LDL-C. Standard enzymatic assays recommended.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

晨尿样本

组织：

Sample Name：

first morning urine samples

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

静脉血样本

组织：

Sample Name：

venous blood samples

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 75 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

随机化方法：本研究采用分层、区组随机法。由独立统计人员使用SAS 9.4软件生成随机分配序列。 分层因素：根据对肾功能进展有明确影响的基线特征，选择 “CKD分期（3期或4期）” 与 “是否合并糖尿病（是或否）” 进行双重分层。 区组设计：在每个层内，采用可变区组长度（4和6） 生成随机序列，以确保分配过程的不可预测性。整个序列包含完整区组及可能的不完整区组，以保证招募结束时组间人数的最大可能平衡

Randomization Procedure (please state who generates the random number sequence and by what method)：

Randomization Method: A stratified, block randomization design was employed in this study. The random allocation sequence was generated by an independent statistician using SAS 9.4 software. Stratification Factors: Dual stratification was performed based on baseline characteristics with a confirmed impact on renal function progression, specifically "CKD stage (stage 3 or 4)" and "diabetes comorbidity (yes or no)". Block Design: Within each stratum, random sequences were generated with variable block sizes (4 and 6) to ensure the unpredictability of the allocation process. The overall sequence consisted of complete blocks and potentially incomplete blocks, aiming to maximize the balance of sample sizes between groups at the end of recruitment.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

双盲

Blinding：

Double blind

是否共享原始数据：

IPD sharing

Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

在期刊论文发表后，读者可联系通讯作者，在合理的要求下，本研究可以提供原始数据及用以数据分析的代码。

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Aterpubication ofthejournal paper, readers may cotact the corresponding suthor and,.pon esonable request, the stuedy can provide the aw data and the code used t analyzethe data.

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

在研究期间使用医院医疗电子病历系统进行数据采集，并通过电子问卷采集本研究的原始数据。所采集的任何数据均被锁定，不能修改。根据GCP规则，原始文件至少应保存15年。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

During the study period,data wilbecolcted using thehospita'selectonic medical record ystem and original data willbe colctedviaelectroni questionnaies,Alcollected data wilbelockedand cannot be modified. According to GCP rules, original documents must be retained for at least 15 years,

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-04-10 16:07:38