ChiCTR2600126104 版本V1.0 版本创建时间2026/06/03 17:13:18 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：

ChiCTR2600126104 

最近更新日期：

Date of Last Refreshed on：

2026-06-03 17:12:59 

注册时间：

Date of Registration：

2026-06-03 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

HAPA理论与多智能体技术融合驱动下膝骨关节炎患者运动治疗健康“交互”系统的干预研究

Public title：

Intervention research on the health "interaction" system of exercise therapy for patients with lower knee osteoarthritis driven by the fusion of HAPA theory and multi-agent technology

注册题目简写：

English Acronym：

研究课题的正式科学名称：

HAPA理论与多智能体技术融合驱动下膝骨关节炎患者运 动治疗健康“交互”系统构建及应用初探

Scientific title：

A Preliminary Study on the Construction and Application of a Health "interaction" System for Movement Therapy in Patients with lower knee osteoarthritis Driven by the Fusion of HAPA Theory and Multi-agent Technology

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：

张怡妮 

研究负责人：

张怡妮 

Applicant：

yinizhang 

Study leader：

yinizhang 

申请注册联系人电话：

Applicant telephone：

+86 182 5824 2015

研究负责人电话：

Study leader's telephone：

+86 182 5824 2015

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：

yinizhang1228@163.com

研究负责人电子邮件：

Study leader's E-mail：

yinizhang1228@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：

浙江省杭州市上城区庆春东路3号

研究负责人通讯地址：

浙江省杭州市上城区庆春东路3号

Applicant address：

No. 3, Qingchun East Road, Shangcheng District, Hangzhou City, Zhejiang Province

Study leader's address：

No. 3, Qingchun East Road, Shangcheng District, Hangzhou City, Zhejiang Province

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：

浙江大学医学院附属邵逸夫医院

Applicant's institution：

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

研究负责人所在单位：

浙江大学医学院附属邵逸夫医院

Affiliation of the Leader：

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang 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：

邵逸夫医院伦理2025研第0899号

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：

浙江大学医学院附属邵逸夫医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

伦理委员会批准日期：

Date of approved by ethic committee：

2025-11-20 00:00:00

伦理委员会联系人：

杨漾池

Contact Name of the ethic committee：

chiyangyang

伦理委员会联系地址：

浙江省杭州市上城区庆春东路3号

Contact Address of the ethic committee：

No. 3, Qingchun East Road, Shangcheng District, Hangzhou City, Zhejiang Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 86886811

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

浙江大学医学院附属邵逸夫医院

Primary sponsor：

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

研究实施负责（组长）单位地址：

浙江省杭州市上城区庆春东路3号

Primary sponsor's address：

No. 3, Qingchun East Road, Shangcheng District, Hangzhou City, Zhejiang Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

浙江

市(区县)：

Country：

China

Province：

Zhejiang

City：

单位(医院)：

邵逸夫医院

具体地址：

浙江省杭州市上城区庆春东路3号

Institution
hospital：

Sir Run Run Shaw Hospital

Address：

No. 3, Qingchun East Road, Shangcheng District, Hangzhou City, Zhejiang Province

经费或物资来源：

医院配套

Source(s) of funding：

Hospital facilities

Target disease：

Knee osteoarthritis

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：

本研究旨在构建一个融合 HAPA 理论与多智能体技术的交互系统，为膝骨关节炎患者提供个性化运动指导，以解决其认知偏差和支持不足问题，最终提升运动治疗依从性。  

Objectives of Study：

This study aims to construct an interactive system that integrates HAPA theory with multi-agent technology to provide personalized exercise guidance for patients with knee osteoarthritis, in order to address their cognitive biases and insufficient support, and ultimately improve compliance with exercise therapy.

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. >=18 周岁。 2. 符合中国骨关节炎诊断标准（2018 版）的 KOA 患者。 3. 意识清楚，认知功能正常，能够用文字或者语言进行正常沟通交流。 4. 具有使用过或正在使用生成式人工智能经历。 5. 自愿参加本研究，并签署知情同意书。

Inclusion criteria

1. >=18 years old. 2. KOA patients who meet the Chinese Diagnostic Criteria for Osteoarthritis (2018 Edition). 3. Clear consciousness, normal cognitive function, and capable of communicating normally through writing or language. 4. Have experience in using or currently using generative artificial intelligence. 5. Voluntarily participate in this study and sign the informed consent form.

排除标准：

1. 弱势群体，包括精神疾病者、认知损伤者、危重患者、孕妇、文盲等。 2. 膝关节严重畸形，跛行甚至不能行走及伴有骨折等无法运动患者。 3. 曾行膝关节镜或人工膝关节置换手术。 4. 6 个月内行下肢手术。 5. 有易诱发不良事故的因素，如严重心脑血管疾病、严重的骨质疏松等。

Exclusion criteria：

1. Vulnerable groups, including those with mental illness, cognitive impairment, critically ill patients, pregnant women, illiterates, etc. 2. Patients with severe knee deformities, limping or even inability to walk, and those with fractures and other conditions that prevent them from moving. 3. Has undergone knee arthroscopy or artificial knee replacement surgery. 4. Undergo lower limb surgery within six months. 5. There are factors that can easily induce adverse accidents, such as severe cardiovascular and cerebrovascular diseases, severe osteoporosis, etc.

研究实施时间：

Study execute time：

从 From 2026-01-01 00:00:00至 To 2028-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-06-03 00:00:00 至 To 2027-06-30 00:00:00  

干预措施：

Interventions：

组别：

干预组

样本量：

37

Group：

Intervention group

Sample size：

干预措施：

干预组在实行常规运动治疗健康教育基础上教由患者应用基于 HAPA 理论的多智能体协同系统开展相关健康教育。患者接受干预的具体内容依据研究中构建形成的健康教育方案。初稿见研究方案中附件 1。

干预措施代码：

Intervention：

The intervention group taught patients to apply multi-agents based on the HAPA theory on the basis of implementing conventional exercise therapy and health education. The collaborative system conducts relevant health education. The specific content of the intervention received by the patients is based on the health education program constructed in the research.The first draft is attached as File 1 of the study plan.

Intervention code：

组别：

对照组

样本量：

37

Group：

Control Group

Sample size：

干预措施：

对照组给予常规健康教育。包括但不限于：门诊医生宣教、康复治疗师宣教、网络资料查询等途径。在患者初次就诊和三个月复查时给予相关运动治疗的宣教。

干预措施代码：

Intervention：

The control group was given routine health education. Including but not limited to: outpatient doctor education, rehabilitation therapist education, and online materials.Through channels such as inquiries. Provide relevant exercise therapy education to patients during their first visit and the three-month follow-up examination.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 浙江 

市(区县)：

  

Country：

China 

Province：

Zhejiang 

City：

 

单位(医院)：

浙江大学医学院附属邵逸夫医院 

单位级别：

三甲 

Institution
hospital：

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

运动依存性

指标类型：

主要指标

Outcome：

Exercise compliance

Type：

Primary indicator

测量时间点：

干预开始前、干预结束后

测量方法：

量表测量

Measure time point of outcome：

Before the intervention begins and after the intervention ends

Measure method：

指标中文名：

运动自我效能

指标类型：

主要指标

Outcome：

Sports self-efficacy

Type：

Primary indicator

测量时间点：

干预开始前、干预结束后

测量方法：

量表测量

Measure time point of outcome：

Before the intervention begins and after the intervention ends

Measure method：

指标中文名：

骨关节炎指数

指标类型：

主要指标

Outcome：

Osteoarthritis index

Type：

Primary indicator

测量时间点：

干预开始前、干预结束后

测量方法：

Measure time point of outcome：

Before the intervention begins and after the intervention ends

Measure method：

指标中文名：

一般资料调查表

指标类型：

次要指标

Outcome：

General Information Questionnaire

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

NA

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

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 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）：

本项研究将受试者随机分为干预组以及对照组。有研究者采用 SPSS25.0 软件的 RV.UNIFORM （0，1）函数（随机种子为 2000000），生成 74 个随机数，最小值为 0.0371，最大值为 0.9826。 采用可视分箱将患者随机分为两组，1 为对照组，2 为干预组。

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

In this study, the subjects were randomly divided into the intervention group and the control group. Some researchers have adopted RV.UNIFORM in SPSS25.0 software, The (0,1) function (with a random seed of 2,000000) generates 74 random numbers, with a minimum value of 0.0371 and a maximum value of 0.9826. Patients were randomly divided into two groups by visual box division, with group 1 being the control group and group 2 being the intervention group.

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：

本研究将对结局评估者（资料收集者）实施盲法。为确保盲法的成功实施，将采取以下具体措施： 1）角色分离：负责资料收集的研究人员不参与患者的招募、随机分组及干预实施过程。 2）标准化评估：资料收集将采用统一的、预先设计的标准化问卷和量表进行，评估者使用中性、统一的指导语。 3）环境与流程控制：评估在独立的场地进行，确保环境中无任何可能暗示患者分组信息的物品或标识。在评估前，资料收集者不会接触到患者的任何与研究干预相关的临床记录。 4）对患者的指导：在每次评估开始前，研究人员会再次提醒患者不要在评估过程中向资料收集者透露其接受的具体干预内容。

Blinding：

This study will blind the outcome evaluators (data collectors). To ensure the successful implementation of the blinding method, the following specific measures will be taken 1) Role separation: Researchers responsible for data collection do not participate in the recruitment, randomization, and intervention implementation processes of patients. 2) Standardized assessment: Data collection will be conducted using a unified, pre-designed standardized questionnaire and scale, with assessors using neutral and uniform instructions. 3) Environmental and process control: The assessment is conducted in an independent venue to ensure that there are no items or signs in the environment that might imply information about patient grouping. Before the assessment, the data collector will not have access to any clinical records of the patients related to the research intervention. 4) Guidance for patients: Before each assessment begins, researchers will once again remind patients not to disclose the specific intervention they have received to the data collector during the assessment process.

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）：

数据完成收集与分析后拟雨2028年5月存档于“浙江省医学科研数据库”，数据保护期1年，故科学数据共享方式为受限共享数据。

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

After the data collection and analysis are completed, it is planned to be archived in the "Zhejiang Medical Research Database" in May 2028. The data protection period is one year. Therefore, the scientific data sharing method is restricted

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：

一、数据采集：本研究将设计一套专用的电子CRF（eCRF），其内容与研究方案完全一致。eCRF将涵盖所有需要收集的数据点，包括：筛查期：?受试者基本信息、知情同意、入选/排除标准核查；基线期：?人口统计学资料、疾病史、合并用药、生命体征以及所有基线结局指标（运动依从性NRS、自我效能量表SEE、WOMAC指数等）；干预期：?系统使用日志、依从性记录、不良事件记录；研究结束时：?所有结局指标的后测数据。 二、数据管理：?本研究将采用?ResMan?临床研究公共管理平台作为核心的数据管理工具。临床资料的采集阶段，问卷的发放和回收由小组成员进行，回收问卷时对问卷的完整性及问卷的填写质量进行核查，对漏填或涂改的问卷，及时向研究对象进行核实及补充，收集的数据及时整理归档，防止数据丢失；加工阶段，由两名具备数据录入经验的研究人员对相关数据进行双人录入核对，对缺失值、极大极小值进行相关的数据清洗和统计填补处理，确保数据分析的可行；处理阶段，由具备专业统计学背景的研究人员对数据统计分析，以验证相关干预结果。

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

I. Data Collection: This study will adopt the ResMan Clinical Research Public Management platform as the core data management tool. This study will design a dedicated electronic CRF (eCRF), whose content is completely consistent with the research plan. eCRF will cover all the data points that need to be collected, including: Screening period: basic information of the subjects, informed consent, and verification of inclusion/exclusion criteria; Baseline period: Demographic data, disease history, concomitant medications, vital signs, and all baseline outcome indicators (Exercise compliance NRS, Self-efficacy Scale SEE, WOMAC index, etc.); Intervention period: System usage logs, compliance records, adverse event records; At the end of the study: Posttest data of all outcome measures. Ii. Data Management: During the clinical data collection stage, the distribution and collection of questionnaires are carried out by team members. When collecting questionnaires, the completeness and filling quality of the questionnaires are checked. For questionnaires that are incomplete or altered, they are promptly verified and supplemented to the research subjects. The collected data is promptly organized and archived to prevent data loss. During the processing stage, two researchers with data entry experience will double-enter and verify the relevant data. They will also perform data cleaning and statistical filling for missing values and maximum and minimum values to ensure the feasibility of data analysis. During the processing stage, researchers with a professional background in statistics conduct statistical analysis on the data to verify the results of the relevant intervention.

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：

  2026-06-03 17:12:59