ChiCTR2600126048 版本V1.0 版本创建时间2026/06/02 18:09:10 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：

 ChiCTR2600126048 

最近更新日期：

Date of Last Refreshed on：

 2026-06-02 18:08:55 

注册时间：

Date of Registration：

 2026-06-02 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

寒地农村心脑血管高危人群两病共防综合干预方案——基于多层级运动干预与控烟戒烟协同促进的集群随机对照试验

Public title：

A comprehensive intervention program for co-prevention of stroke and coronary heart disease among high-risk populations in cold rural areas: a cluster randomized controlled trial based on the synergy of multi-level physical activity intervention and smoking cessation

注册题目简写：

寒地农村两病共防综合干预集群随机对照试验

English Acronym：

Co-prevention of CVD in Cold Rural Areas (CVD-CCRA)

研究课题的正式科学名称：

寒地农村心脑血管高危人群两病共防综合干预方案——基于多层级运动干预与控烟戒烟协同促进的集群随机对照试验

Scientific title：

Comprehensive Intervention Program for Co-prevention of Stroke and Coronary Heart Disease Among High-Risk Populations in Cold Rural Areas: A Cluster Randomized Controlled Trial Based on the Synergistic Promotion of Multi-Level Physical Activity Intervention and Smoking Cessation

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：

段萍 

研究负责人：

孙殿军 

Applicant：

Duan Ping 

Study leader：

Sun Dianjun 

申请注册联系人电话：

Applicant telephone：

 +86 187 5656 6983

研究负责人电话：

Study leader's
telephone：

+86 133 1368 5318

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：

 2024020239@hrbmu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

 hrbmusdj@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：

黑龙江省哈尔滨市南岗区保健路157号

研究负责人通讯地址：

黑龙江省哈尔滨市南岗区保健路157号

Applicant address：

No. 157 Baojian Road, Nangang District, Harbin, Heilongjiang, China

Study leader's address：

No. 157 Baojian Road, Nangang District, Harbin, Heilongjiang, China

申请注册联系人邮政编码：

Applicant postcode：

 150081

研究负责人邮政编码：

Study leader's postcode：

 150081

申请人所在单位：

哈尔滨医科大学地方病控制中心

Applicant's institution：

Center for Endemic Disease Control, Harbin Medical University

研究负责人所在单位：

哈尔滨医科大学地方病控制中心

Affiliation of the Leader：

Center for Endemic Disease Control, Harbin Medical University

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 hrbmuecdc20260305

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：

哈尔滨医科大学地方病控制中心伦理审查委员会

Name of the ethic committee：

Ethics Review Committee of Center for Endemic Disease Control, Harbin Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-04-22 00:00:00

伦理委员会联系人：

刘晓娜

Contact Name of the ethic committee：

Liu Xiaona

伦理委员会联系地址：

黑龙江省哈尔滨市南岗区保健路157号

Contact Address of the ethic committee：

No. 157 Baojian Road, Nangang District, Harbin, Heilongjiang, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 138 5454 7340

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 xiaonaliu_2013@163.com

研究实施负责（组长）单位：

哈尔滨医科大学地方病控制中心

Primary sponsor：

Center for Endemic Disease Control, Harbin Medical University

研究实施负责（组长）单位地址：

黑龙江省哈尔滨市南岗区保健路157号

Primary sponsor's address：

No. 157 Baojian Road, Nangang District, Harbin, Heilongjiang, 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)：

黑龙江省

市(区县)：

哈尔滨市

Country：

China

Province：

Heilongjiang

City：

Harbin

单位(医院)：

哈尔滨医科大学地方病控制中心

具体地址：

黑龙江省哈尔滨市南岗区保健路157号

Institution
hospital：

Center for Endemic Disease Control, Harbin Medical University

Address：

No. 157 Baojian Road, Nangang District, Harbin, Heilongjiang, China

经费或物资来源：

癌症、心脑血管、呼吸和代谢性疾病防治研究国家科技重大专项

Source(s) of funding：

National Major Science and Technology Program for the Prevention and Treatment of Cancer, Cardiovascular and Cerebrovascular Diseases, Respiratory Diseases, and Metabolic Diseases

研究疾病：

脑卒中；冠心病  

Target disease：

Stroke; Coronary Heart Disease

研究疾病代码：

I20-I25;I60-I69

Target disease code：

I20-I25;I60-I69

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：

整群随机分组 

Study design：

Cluster randomization 

研究目的：

针对寒地农村心脑血管疾病高危人群，评价整合多层级体力活动干预与分级控烟戒烟干预的"两病共防"综合干预模式的效果，通过运动与戒烟的协同促进，降低研究对象血压、血脂、血糖等心脑血管疾病危险因素水平，从而减少脑卒中和冠心病的发病风险，为寒地农村地区心脑血管疾病综合防控提供循证依据。  

Objectives of Study：

To evaluate the effectiveness of a comprehensive "co-prevention" intervention integrating multi-level physical activity promotion and staged smoking cessation support among cardiovascular high-risk adults in cold rural China, with the aim of reducing CVD risk factors (blood pressure, lipids, blood glucose) and lowering the incidence risk of stroke and coronary heart disease, thereby providing evidence-based guidance for CVD prevention in cold rural settings.

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 35～75 岁，性别不限； 2.在研究所在行政村连续居住≥1 年，能完成全程随访； 3.采用研究团队前期建立并验证的冠心病和脑卒中 5 年发病风险预测模型，并结合 China-PAR 模型（Prediction for ASCVD Risk in China）进行个体风险评估； 4.当前吸烟者，即过去 30 天内至少吸烟一次，含每日吸烟与非每日吸烟者； 5.能够独立完成日常生活基本活动（如步行、站立、上下楼梯等），并经运动风险初筛及临床评估判定适宜参与中等强度体力活动干预； 6.具有基本认知和沟通能力，能理解研究目的及干预内容； 7.自愿参加本研究，并签署书面知情同意书。

Inclusion criteria

1. Adults aged 35–75 years, regardless of sex; 2. Continuous residence in the study administrative village for at least 1 year and the ability to complete the entire follow-up period; 3. Individual risk assessment conducted using the previously developed and validated 5-year risk prediction models for coronary heart disease and stroke established by the research team, combined with the China-PAR model (Prediction for ASCVD Risk in China); 4. Current smokers, defined as individuals who have smoked at least once within the past 30 days, including both daily and non-daily smokers; 5. Ability to independently perform basic activities of daily living (e.g., walking, standing, climbing stairs), and deemed suitable for participation in moderate-intensity physical activity intervention based on exercise risk screening and clinical evaluation; 6. Possession of basic cognitive and communication abilities, with the capacity to understand the study objectives and intervention content; 7. Voluntary participation in the study and provision of written informed consent.

排除标准：

1.既往明确诊断为脑卒中（缺血性/出血性）、短暂性脑缺血发作（Transient ischemic attack，TIA）、冠心病等明确的心脑血管事件者； 2.存在严重心脏疾病或运动高风险状态：中重度至重度心功能不全（New York Heart Association，NYHA III—IV级）、严重心律失常、不稳定型心绞痛、近6个月急性心血管事件等； 3.存在严重影响参与干预研究的躯体疾病如重度骨关节炎、帕金森晚期、偏瘫等； 4.近6个月内有严重跌倒史或经医师评估存在较高运动损伤风险； 5.中重度认知功能障碍、严重精神障碍或严重听力/语言障碍，无法配合干预与评估； 6.近3个月内接受重大手术或正接受恶性肿瘤系统性治疗； 7.对戒烟干预药物（尼古丁含片、伐尼克兰等）有明确过敏史或禁忌症； 8.正在参与其他类似的慢性病干预研究； 9.研究人员评估依从性差、无法完成干预与全程随访者

Exclusion criteria：

1. Individuals with a previous confirmed diagnosis of stroke (ischemic or hemorrhagic), transient ischemic attack (TIA), coronary heart disease, or other definite cerebrovascular events; 2. Presence of severe heart disease or conditions associated with high exercise risk, including moderate-to-severe or severe heart failure (New York Heart Association [NYHA] class III–IV), severe arrhythmia, unstable angina, or acute cardiovascular events within the past 6 months; 3. Presence of serious physical diseases that may substantially interfere with participation in the intervention study, such as severe osteoarthritis, advanced Parkinson’s disease, or hemiplegia; 4. History of severe falls within the past 6 months or high risk of exercise-related injury as assessed by a physician; 5. Moderate-to-severe cognitive impairment, severe psychiatric disorders, or severe hearing/language impairment that would prevent cooperation with intervention and assessment procedures; 6. Major surgery within the past 3 months or ongoing systemic treatment for malignant tumors; 7. Known allergy or contraindication to smoking cessation medications (e.g., nicotine lozenges, varenicline); 8. Current participation in other similar chronic disease intervention studies; 9. Individuals assessed by investigators as having poor compliance or being unable to complete the intervention and full follow-up.

研究实施时间：

Study execute time：

从 From 2026-06-01 00:00:00至 To 2027-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-06-05 00:00:00 至 To 2026-06-30 00:00:00

干预措施：

Interventions：

组别：

干预组

样本量：

 260

Group：

Intervention Group

Sample size：

干预措施：

多层级"运动+戒烟"协同综合干预，包括个体化双季节运动处方、分级戒烟干预、同伴互助小组、家庭支持、社区环境建设及"健康积分银行"激励机制；干预周期18个月

干预措施代码：

Intervention：

Multi-level synergistic physical activity and smoking cessation intervention, including individualized dual-season exercise prescription, staged smoking cessation support, peer support groups, family involvement, community environment building, and a health incentive system; 18-month intervention period

Intervention code：

组别：

对照组

样本量：

 260

Group：

Control Group

Sample size：

干预措施：

常规CVD防控健康教育：入组时开展1次健康讲座并发放标准化宣传材料，随访期间仅完成结局指标测量，不提供个体化干预

干预措施代码：

Intervention：

Routine CVD health education: one health lecture and standard printed materials at enrollment; outcome measurements only during follow-up, with no individualized intervention

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 黑龙江省 

市(区县)：

 大庆市 

Country：

China

Province：

Heilongjiang Province

City：

Daqing City

单位(医院)：

 黑龙江省大庆市杜尔伯特蒙古族自治县部分农村地区 

单位级别：

 无 

Institution
hospital：

Selected rural areas of Dorbod Mongol Autonomous County, Daqing City, Heilongjiang Province

Level of the institution：

NA

测量指标：

Outcomes：

指标中文名：

收缩压变化值

指标类型：

主要指标

Outcome：

NameChange in Systolic Blood Pressure (SBP)

Type：

Primary indicator

测量时间点：

基线、干预后6个月、12个月、18个月

测量方法：

经校准自动电子血压计，静坐休息≥5分钟后连续测量3次，取后2次均值

Measure time point of outcome：

Baseline, 6 months, 12 months, 18 months post-intervention

Measure method：

Calibrated automated sphygmomanometer; average of 2 readings after ≥5 min rest

指标中文名：

7天点戒烟率

指标类型：

次要指标

Outcome：

7-day point prevalence abstinence rate

Type：

Secondary indicator

测量时间点：

1周、2周、1、3、6、12、18个月

测量方法：

自报+呼出气CO验证

Measure time point of outcome：

1 week, 2 weeks, 1, 3, 6, 12, 18 months

Measure method：

Self-report + exhaled CO verification

指标中文名：

持续戒烟率

指标类型：

次要指标

Outcome：

Sustained smoking abstinence rate

Type：

Secondary indicator

测量时间点：

6、12、18个月

测量方法：

自报+呼出气CO验证

Measure time point of outcome：

6, 12, 18 months

Measure method：

Self-report + exhaled CO verification

指标中文名：

体力活动水平

指标类型：

次要指标

Outcome：

Physical activity level (IPAQ-Short score)

Type：

Secondary indicator

测量时间点：

基线、3、6、12、18个月

测量方法：

国际体力活动问卷短版

Measure time point of outcome：

Baseline, 3, 6, 12, 18 months

Measure method：

IPAQ-Short

指标中文名：

呼出气CO浓度

指标类型：

次要指标

Outcome：

Exhaled carbon monoxide concentration

Type：

Secondary indicator

测量时间点：

基线、1、3、6、12、18个月

测量方法：

呼出气CO检测仪

Measure time point of outcome：

Baseline, 1, 3, 6, 12, 18 months

Measure method：

Exhaled CO analyzer

指标中文名：

冠心病/脑卒中5年发病风险评分

指标类型：

次要指标

Outcome：

5-year CVD risk score (CHD and stroke)

Type：

Secondary indicator

测量时间点：

基线、6、12、18个月

测量方法：

研究团队验证预测模型

Measure time point of outcome：

Baseline, 6, 12, 18 months

Measure method：

Validated prediction model

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

静脉血

Sample Name：

Blood

Tissue：

Venous blood

人体标本去向

 使用后销毁  

说明

用于血糖、血脂等生化指标检测，于基线、6个月、18个月采集，检测完成后低温保存于研究机构生物样本库，保存期5年，到期后销毁

Fate of sample：

Destruction after use  

Note：

Used for biochemical testing (blood glucose, lipid profile) collected at baseline, 6 and 18 months; stored in the institutional biobank at low temperature for 5 years after testing, then destroyed upon expiration.

标本中文名：

尿液

组织：

尿液

Sample Name：

Urine

Tissue：

Urine

人体标本去向

 使用后保存  

说明

随机子样本用于尿可替宁含量检测以客观验证戒烟状态，检测完成后低温保存于研究机构生物样本库，保存期5年，到期后销毁。

Fate of sample：

Preservation after use  

Note：

Random sub-samples used for urinary cotinine testing to objectively verify smoking abstinence; stored in the institutional biobank at low temperature for 5 years after testing, then destroyed upon expiration.

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 35 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）：

以行政村为集群随机单位，根据村级CVD风险水平、体力活动水平及男性吸烟率进行分层，在各层内采用区组随机化方法，由研究团队统计人员使用统计软件（SAS/R）生成随机序列，按1:1比例将行政村分配至干预组或对照组，采用密封不透明信封法实施分配隐藏。

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

Administrative villages serve as the unit of cluster randomization. Villages are stratified by baseline CVD risk level, physical activity level, and male smoking rate. Within each stratum, block randomization is applied. A statistician independent of the study generates the random allocation sequence using SAS/R software. Villages are allocated to intervention or control groups in a 1:1 ratio. Allocation concealment is ensured using sealed opaque envelopes opened sequentially on-site.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

本研究采用单盲设计。由于干预性质（运动与戒烟行为干预），受试者及干预实施者（村医）无法设盲。施盲对象为：①结局评估人员：负责测量血压、采集血样、实施问卷调查的研究人员对研究对象的分组情况设盲；②数据统计分析人员：在数据锁定并完成统计分析前，对分组信息设盲。

Blinding：

This study employs a single-blind design. Due to the nature of the behavioral intervention (physical activity and smoking cessation), blinding of participants and intervention implementers (village doctors) is not feasible. Blinding is applied to: ① Outcome assessors: research staff responsible for blood pressure measurement, blood sample collection, and questionnaire administration are blinded to group allocation; ② Data analysts: statisticians remain blinded to group assignment until data lock and completion of the statistical analysis.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

是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）：

研究结束并完成主要结果发表后2年内，将去标识化的个体参与者数据（IPD）、数据字典、研究方案及统计分析计划通过公开数据平台进行共享。有意向使用数据的研究者可通过电子邮件向研究负责人提出申请，经审核批准后获取数据，数据仅限用于非商业性学术研究目的。

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

De-identified individual participant data (IPD), data dictionary, study protocol, and statistical analysis plan will be made available within 2 years after publication of the primary results. Researchers interested in accessing the data may submit a request via email to the principal investigator. Access will be granted upon review and approval, and data use is restricted to non-commercial academic research purposes only.

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：

病例记录表（CRF）：采用纸质标准化随访记录表（见方案附件2），由经统一培训的村医在每次随访时现场填写，内容涵盖体格测量、烟草控制、运动依从性、安全性评估等模块，填写完成后由研究团队定期回收核查。电子数据采集系统（EDC）：采用EpiData软件建立电子数据库，实行双人双录入与逻辑核查机制，对缺失值和异常值进行实时核查与追溯，数据存储于加密的研究专用服务器，仅授权研究人员可访问。

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

Case Record Form (CRF): Standardized paper-based follow-up record forms (see Appendix 2 of the protocol) are completed on-site by trained village doctors at each follow-up visit, covering physical measurements, tobacco control, exercise adherence, and safety assessment. Forms are regularly collected and reviewed by the research team. Electronic Data Capture (EDC): An electronic database is established using EpiData software with double data entry and logical validation. Missing and outlier values are checked and traced in real time. All data are stored on an encrypted, study-dedicated server accessible only to authorized research personnel.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2026-06-02 18:08:55