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基于循证的住院老年抑郁症合并认知衰弱患者运动-认知干预方案构建及实证研究
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注册号：

Registration number：

 ChiCTR2500113655 

最近更新日期：

Date of Last Refreshed on：

 2025-12-01 18:07:16 

注册时间：

Date of Registration：

 2025-12-01 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于循证的住院老年抑郁症合并认知衰弱患者运动-认知干预方案构建及实证研究

Public title：

Construction and Empirical research of exercise-cognitive intervention Program for hospitalized elderly patients with depression complicated with cognitive frailty based on evidence

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于循证的住院老年抑郁症合并认知衰弱患者运动-认知干预方案构建及实证研究

Scientific title：

Construction and Empirical research of exercise-cognitive intervention Program for hospitalized elderly patients with depression complicated with cognitive frailty based on evidence

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：

李洁 

研究负责人：

李洁 

Applicant：

Li Jie 

Study leader：

Li Jie 

申请注册联系人电话：

Applicant telephone：

 +86 373 3373985

研究负责人电话：

Study leader's
telephone：

+86 373 337 3985

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：

 ljie0914@163.com

研究负责人电子邮件：

Study leader's E-mail：

 ljie0914@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：

河南省新乡市牧野区前进路207号

研究负责人通讯地址：

河南省新乡市牧野区前进路207号

Applicant address：

No. 207, Qianjin Road, Muye District, Xinxiang City, Henan Province

Study leader's address：

No. 207, Qianjin Road, Muye District, Xinxiang City, Henan 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：

新乡医学院第二附属医院

Applicant's institution：

The Second Affiliated Hospital of Xinxiang Medical University

研究负责人所在单位：

新乡医学院第二附属医院

Affiliation of the Leader：

The Second Affiliated Hospital of Xinxiang 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：

 XYEFYLL-（科研）-2025-87

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：

新乡医学院第二附属医院伦理委员会

Name of the ethic committee：

Ethics Committee of the Second Affiliated Hospital of Xinxiang Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-08-07 00:00:00

伦理委员会联系人：

朱利芳

Contact Name of the ethic committee：

Zhu Lifang

伦理委员会联系地址：

河南省新乡市牧野区前进路207号

Contact Address of the ethic committee：

No. 207, Qianjin Road, Muye District, Xinxiang City, Henan Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 373 3373500

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 379674908@qq.com

研究实施负责（组长）单位：

新乡医学院第二附属医院

Primary sponsor：

The Second Affiliated Hospital of Xinxiang Medical University

研究实施负责（组长）单位地址：

河南省新乡市牧野区前进路207号

Primary sponsor's address：

No. 207, Qianjin Road, Muye District, Xinxiang City, Henan 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)：

河南省

市(区县)：

Country：

China

Province：

Henan

City：

单位(医院)：

新乡医学院第二附属医院

具体地址：

河南省新乡市牧野区前进路207号

Institution
hospital：

The Second Affiliated Hospital of Xinxiang Medical University

Address：

No. 207, Qianjin Road, Muye District, Xinxiang City, Henan Province

经费或物资来源：

河南省医学科技攻关联合共建项目

Source(s) of funding：

Joint Construction Project of Medical Science and Technology Research in Henan Province

研究疾病：

认知衰弱症（Cognitive Frailty，CF）  

Target disease：

Cognitive Frailty (CF)

研究疾病代码：

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：

（1）整合循证证据：系统检索与评价国内外住院老年抑郁症合并认知衰弱患者运动-认知双重任务干预的最佳证据，形成科学、规范的《住院老年抑郁症合并认知衰弱患者运动-认知干预证据总结》。 （2）构建本土化方案：基于证据总结，通过多学科协作与德尔菲专家函询，开发兼具科学性、可行性及临床适用性的住院老年抑郁症合并认知衰弱患者运动-认知结构化干预方案。 （3）验证干预效果：通过三臂随机对照试验，明确运动-认知联合干预对患者认知功能、身体功能、自我效能及跌倒风险的改善效果，为临床推广提供实证支撑。  

Objectives of Study：

1. Integrate evidence-based evidence: Systematically search for and evaluate the best evidence of movement-cognitive dual task intervention for hospitalized elderly patients with depression complicated with cognitive frailty at home and abroad, and form a scientific and standardized "Summary of Movement-Cognitive Intervention Evidence for Hospitalized Elderly Patients with depression Complicated with Cognitive Frailty". 2. Develop localized solutions: Based on evidence summary, through multidisciplinary collaboration and Delphi expert consultation, develop a structured movement-cognitive intervention plan for hospitalized elderly patients with depression complicated with cognitive frailty that is scientific, feasible and clinically applicable. 3. Verify the intervention effect: Through a three-arm randomized controlled trial, clarify the improvement effect of the combined exercise-cognitive intervention on patients' cognitive function, physical function, self-efficacy and fall risk, and provide empirical support for clinical promotion.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

1.有晚期、严重、急性、亚急性，或不稳定的脑器质性疾病或躯体疾病，影响指标观察和安全性。
2.诊断为阿尔茨海默病或其他类型痴呆：满足美国精神障碍诊断与统计手册第五版（DSM-V）重度神经认知障碍诊断标准。
3.合并其他精神病史者。
4.近2周曾服用可引起认知改变、平衡障碍或损害重要脏器的药物。
5.日常生活活动能力（Barthel指数）<50分，独立站立行走能力<10m。

Exclusion criteria：

1.There are advanced, severe, acute, subacute or unstable organic brain diseases or physical diseases that affect the observation of indicators and safety.
2.Diagnosed with Alzheimer's disease or other types of dementia: Meets the diagnostic criteria for severe neurocognitive impairment in the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) of the United States.
3.Those with a history of other mental illnesses.
4.In the past two weeks, I have taken drugs that can cause cognitive changes, balance disorders or damage to important organs.
5.Activities of daily living (Barthel index) <50 points, independent standing and walking ability <10 meters.

研究实施时间：

Study execute time：

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

征募观察对象时间：

Recruiting time：

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

干预措施：

Interventions：

组别：

CST组

样本量：

 31

Group：

CST Group

Sample size：

干预措施：

采用小组锻炼形式，通过生活化场景激活情景记忆、执行功能与语义处理等多维认知域。主题活动采用“引导-参与-强化”三阶模式，由精神康复治疗师主导。主要包含轻轻听、童年往事、熟悉的味道、时事、名人名地、成语连连看、创意活动、物件分类、导向、金钱运用、数字游戏、文字游戏等主题。

干预措施代码：

Intervention：

Using a group exercise format, it activates multiple cognitive domains such as episodic memory, executive function, and semantic processing through life-like scenarios. The thematic activities follow a three-step model of "guide-participate-reinforce," led by mental rehabilitation therapists. They mainly include themes such as gentle listening, childhood memories, familiar tastes, current affairs, famous people and places, idiom matching, creative activities, object classification, orientation, money usage, number games, and word games.

Intervention code：

组别：

ME+CST组

样本量：

 31

Group：

ME+CST group

Sample size：

干预措施：

采用小组锻炼形式，在 CST 组基础上接受 ME 训练，整个运动干预过程在室内环境中进行，医学研究生将实时监测老年人的活动强度，以确保老年人的运动安全。运动干预包括热身、有训练力量训练、平衡训练、柔韧性训练等。 干预方案每周进行 2 次，每次约 60 分钟，共持续 6 周。

干预措施代码：

Intervention：

The intervention uses a group exercise format, with participants in the CST group receiving ME training. The entire exercise intervention takes place indoors, and medical graduate students will monitor the activity intensity of the elderly in real time to ensure their exercise safety. The exercise intervention includes warm-up, strength training, balance training, and flexibility training. The intervention program is conducted twice a week, with each session lasting about 60 minutes, for a total of 6 weeks.

Intervention code：

组别：

对照组

样本量：

 31

Group：

Control group

Sample size：

干预措施：

对照组患者接受常规护理干预

干预措施代码：

Intervention：

Patients in the control group received routine nursing interventions

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 河南省 

市(区县)：

  

Country：

China

Province：

Henan

City：

单位(医院)：

 新乡医学院第二附属医院 

单位级别：

 三级甲等 

Institution
hospital：

The Second Affiliated Hospital of Xinxiang Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

社会自我效能感

指标类型：

主要指标

Outcome：

Perceived Social Self Effcacy, PSSE

Type：

Primary indicator

测量时间点：

干预前、干预3周及干预6周

测量方法：

问卷调查：用于评估在社交场合中发展社交技能和维持社交关系的信心和信念。评估内容主要包含18个项目，每个项目采用 Likent5点计分，1分代表完全没信心，5分代表完全有信心，分数越低表示个体的社会自我效能感越低。该量表的Cronbach'a系数为0.825。

Measure time point of outcome：

Before the intervention, at 3 weeks of intervention and at 6 weeks of intervention

Measure method：

Questionnaire survey: It is used to assess the confidence and belief in developing social skills and maintaining social relationships in social situations. The assessment mainly consists of 18 items. Each item is scored on a 5-point Likent scale, with 1 point indicating complete lack of confidence and 5 points indicating complete confidence. The lower the score, the lower the individual's social self-efficacy. The Cronbach's a coefficient of this scale is 0.825.

指标中文名：

衰弱表型

指标类型：

主要指标

Outcome：

Frailty Phenotype, FP

Type：

Primary indicator

测量时间点：

干预前、干预3周及干预6周

测量方法：

问卷调查+客观测量：该量表是目前公认的评估身体衰弱的金标准，由Fried等于2001年制定，评估内容主要包括体重减轻（过去1年内体重下降4.5kg或25%）、疲惫感（近1周内，有三天以上做任何事情感到费力或缺乏干劲）、步速缓慢（步行6m，<1m/s 为异常）、握力下降（握力器测量：男性<26kg，女性<18kg）、低体能（每周体力活动男性<383kcal，女性<270kcal）5个部分。FP量表的

Measure time point of outcome：

Before the intervention, at 3 weeks of intervention and at 6 weeks of intervention

Measure method：

Questionnaire survey + objective measurement This scale is currently recognized as the gold standard for assessing physical frailty. It was developed by Fried et al. in 2001. The assessment mainly includes weight loss (a decrease of 4.5kg or 25% in weight within the past year), fatigue (feeling strenuous or lacking motivation to do anything for more than three days within the past week), and slow walking speed (walking 6 meters There are five aspects: abnormal (less than 1m/s), decreased grip s

指标中文名：

一般资料

指标类型：

主要指标

Outcome：

General Information

Type：

Primary indicator

测量时间点：

干预前、干预3周及干预6周

测量方法：

问卷调查：该调查表由研究者查阅文献后自行设计，主要由社会人口学信息和身体健康状况两部分内容构成。

Measure time point of outcome：

Before the intervention, at 3 weeks of intervention and at 6 weeks of intervention

Measure method：

Questionnaire survey: This questionnaire was designed by researchers after reviewing literature and mainly consists of two parts: sociodemographic information and physical health status.

指标中文名：

起立-行走计时

指标类型：

主要指标

Outcome：

Timed Up and Go, TUGT

Type：

Primary indicator

测量时间点：

干预前、干预3周及干预6周

测量方法：

测量：可反映受试者的灵活性、平衡能力和综合功能。指导患者先坐在有扶手的座椅上，在研究者发出口令后，患者使用最快并且稳定的速度向前步行3m，过标记物后返回坐到椅子上的时间，测量2次，记录最短时间，用秒（s）表示。

Measure time point of outcome：

Before the intervention, at 3 weeks of intervention and at 6 weeks of intervention

Measure method：

Measurement: It can reflect the flexibility, balance ability and comprehensive function of the subjects. The patient was instructed to first sit on a chair with armrests. After the researcher gave the command, the patient walked forward at the fastest and most stable speed for 3 meters, passed the marker, and then returned to sit on the chair. The time was measured twice, and the shortest time was recorded, expressed in seconds (s).

指标中文名：

蒙特利尔认知

指标类型：

主要指标

Outcome：

Montreal Cognitive, MoCA

Type：

Primary indicator

测量时间点：

干预前、干预3周及干预6周

测量方法：

问卷调查：该量表由Nasreddine等于2004年编制，在2007年由王炜等译成中文版。MOCA量表对轻度认知障碍患者具有较高的敏感性，评估内容主要包括视空间与执行能力、命名、记忆、注意、语言流畅性、延迟回忆、抽象思维、定向力8个方面，MoCA得分>26 分时认知能力正常，18-26分为轻度认知障碍，<18分为认知障碍状态，当教育年限不足12年则加1分。中文版MoCA的敏感度为0.92，特异性为

Measure time point of outcome：

Before the intervention, at 3 weeks of intervention and at 6 weeks of intervention

Measure method：

Questionnaire survey: This scale was developed by Nasreddine et al. in 2004 and translated into Chinese by Wang Wei et al. in 2007. The MOCA scale is highly sensitive to patients with mild cognitive impairment. The assessment mainly covers eight aspects: visuospatial and executive ability, naming, memory, attention, language fluency, delayed recall, abstract thinking, and orientation. A MoCA score greater than 26 indicates normal cognitive ability, 18-26 indicates mild cognitive impairment, and

指标中文名：

修订版跌倒效能

指标类型：

主要指标

Outcome：

Modified Fall Efficacy

Type：

Primary indicator

测量时间点：

干预前、干预3周及干预6周

测量方法：

问卷调查：该量表由郝燕萍等于2007年译成中文版，用于评估老年人日常活动时预防跌倒的信心。评估内容主要包括室内活动、室外活动2个维度，共14个条目。每个条目0~10分，0分为没有信心，5分为有一定的信心，10分为非常有信心，分数越高表明对预防跌倒的信心越大。该量表的 Cronbach'sa系数为0.998。

Measure time point of outcome：

Before the intervention, at 3 weeks of intervention and at 6 weeks of intervention

Measure method：

Questionnaire survey: This scale was translated into Chinese by Hao Yanping et al. in 2007 and is used to assess the confidence of the elderly in preventing falls during their daily activities. The assessment mainly includes two dimensions: indoor activities and outdoor activities, with a total of 14 items. Each item is scored from 0 to 10. 0 indicates a lack of confidence, 5 indicates a certain level of confidence, and 10 indicates very high confidence. The higher the score, the greater the con

指标中文名：

汉密尔顿抑郁

指标类型：

主要指标

Outcome：

Hamilton Depression,HAMD

Type：

Primary indicator

测量时间点：

干预前、干预3周及干预6周

测量方法：

问卷调查：该量表是最常用的抑郁他评量表。适用于具有抑郁症状的成年人，可归纳为7类因子结构，分别为：焦虑/躯体化、体重、认知障碍、日夜变化、阻滞、睡眠障碍、绝望感，本研究使用最常用的17项版本。HAMD 大部分项目采用0-4分的5级评分法。总分超过24分，可能为严重抑郁；超过17分可能为中等程度的抑郁；如果小于7分，病人则没有抑郁症状。该量表Cronbach系数>0.7，其信度和效度均>0.90，内

Measure time point of outcome：

Before the intervention, at 3 weeks of intervention and at 6 weeks of intervention

Measure method：

Questionnaire survey: This scale is the most commonly used depression rating scale. It is applicable to adults with depressive symptoms and can be classified into seven types of factor structures, namely: anxiety/somatization, weight, cognitive impairment, day-night variation, block, sleep disorder, and sense of hopelessness. This study uses the most commonly used version of 17 items. Most projects in HAMD are scored on a 5-point scale ranging from 0 to 4. A total score exceeding 24 points may i

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 60 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）：

研究者根据纳入与排除标准，使用随机数字表法对研究对象进行分组。按照患者的入院顺序编号，根据随机表上的数字，对研究对象进行再次编号，使数字编号从小到大排列。若出现随机数字相同的情况，将以先出现的数字为准。根据序号将研究对象分为三组，分别为对照组、CST组和ME+CST组。

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

According to the inclusion and exclusion criteria, the research subjects were grouped using the random number table method. According to the order of admission of the patients, the research subjects were numbered again based on the numbers on the random table, and the numbers were arranged in ascending order. In the event that the random numbers are the same, the number that appears first shall prevail. The research subjects were divided into three groups according to the serial numbers, namely the control group, the CST group and the ME+CST 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：

双盲

Blinding：

Double blind

是否共享原始数据：

IPD sharing

否No

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）：

无

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

None

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：

对问卷收集者进行培训，培训合格方可进行数据收集。问卷当场发放，当场回收。电子版双人录入。严格保密。

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

The questionnaire collectors should be trained. Only those who pass the training can proceed with data collection. Questionnaires were distributed and collected on the spot. Electronic version is entered by two people. Strict confidentiality.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-12-01 18:07:02
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