ChiCTR2400084469 版本V1.0 版本创建时间2024/05/17 09:04:15 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：

ChiCTR2400084469 

最近更新日期：

Date of Last Refreshed on：

2024-05-17 09:04:10 

注册时间：

Date of Registration：

2024-05-17 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

研究二：多模式运动对老年Ⅱ型糖尿病患者认知功能的影响及脑神经机制研究

Public title：

Study 2:Multi-component exercise for elderly patients with type II diabetes Study on the influence of cognitive function and brain neural mechanism

注册题目简写：

English Acronym：

研究课题的正式科学名称：

多模式运动对老年Ⅱ型糖尿病患者认知功能的影响及脑神经机制研究

Scientific title：

Multi-component exercise for elderly patients with type II diabetes Study on the influence of cognitive function and brain neural mechanism

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：

孙志远 

研究负责人：

孙志远 

Applicant：

Sun Zhiyuan 

Study leader：

Sun Zhiyuan 

申请注册联系人电话：

Applicant telephone：

+86 159 6968 8339

研究负责人电话：

Study leader's telephone：

+86 159 6968 8339

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：

1213225245@qq.com

研究负责人电子邮件：

Study leader's E-mail：

1213225245@qq.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：

山东省济南市历城区世纪大道10600号

研究负责人通讯地址：

山东省济南市历城区世纪大道10600号

Applicant address：

Shandong Sport University,10600 Century Avenue, Jinan City, Shandong Province

Study leader's address：

Shandong Sport University,10600 Century Avenue, Jinan City, Shandong 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：

山东体育学院

Applicant's institution：

Shandong Sport University

研究负责人所在单位：

山东体育学院

Affiliation of the Leader：

Shandong Sport 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：

2023026(研究二)

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：

山东体育学院运动科学伦理委员会

Name of the ethic committee：

Sports Science Ethics Committee of Shandong Sport University

伦理委员会批准日期：

Date of approved by ethic committee：

2023-11-30 00:00:00

伦理委员会联系人：

沙芮伊

Contact Name of the ethic committee：

Sha Rui Yi

伦理委员会联系地址：

山东省济南市世纪大道10600号山东体育学院

Contact Address of the ethic committee：

Shandong Sport University, 10600 Century Avenue, Jinan City, Shandong Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 531 8965 5058

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：

山东体育学院

Primary sponsor：

Shandong Sport University

研究实施负责（组长）单位地址：

山东省济南市世纪大道10600号

Primary sponsor's address：

10600 Century Avenue, Jinan City, Shandong 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)：

山东

市(区县)：

Country：

China

Province：

Shandong

City：

单位(医院)：

山东体育学院

具体地址：

济南市世纪大道10600号

Institution
hospital：

Shandong Sport University

Address：

10600 Century Avenue, Jinan City

经费或物资来源：

中央引导地方科技发展资金项目、山东省重大研发计划和泰山学者专项经费

Source(s) of funding：

The central government guides the local science and technology development fund project, the major research and development plan of Shandong Province and the special funds of Taishan scholars.

Target disease：

Type II diabetes mellitus with cognitive dysfunction

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本研究为单中心随机对照实验，通过构建多模式运动干预方案并考察 20 周多模式运动干预前、中、后以及干预后 12 周被试认知行为、血清生化指标和脑功能特性的变化，探索多模式运动改善认知功能的行为表现和脑功能特性（任务态和静息态）的量效、时序及时程关系。  

Objectives of Study：

This study is a single-center randomized controlled experiment. By constructing a multi-mode exercise intervention program and investigating the changes of cognitive behavior, serum biochemical indicators and brain function characteristics of subjects before, during, after and 12 weeks after 20 weeks of multi-mode exercise intervention, the behavioral performance of multi-mode exercise to improve cognitive function and the dose-effect, timing and time-course relationship of brain function characteristics ( task state and resting state ) were explored.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

参考 2022 年中华医学会糖尿病学分会颁布的《中国老年2型糖尿病防治临床指南（2022 年版）》中 T2D 的诊断标准。①FBG ≥ 7.0 mmol/L；②餐后 2 h 血糖≥ 11.1 mmol/L；③HbA1c ≥ 6.5%；④诊断为 2 型糖尿病或正使用降糖药。符合上述任一条件即可诊断为 2 型糖尿病。 MCI 诊断标准参照《2018 中国痴呆与认知障碍诊治指南（五）：轻度认知障碍的诊断与治疗》，主要包括：①患者或知情者、或有经验的临床医师发现有认知损害；②存在1个或多个认知功能领域损害的客观证据；③复杂的工具性日常能力可以有轻微损害，但保持独立的日常生活能力；④尚未达到痴呆的诊断。 ①符合 T2D 标准； ②符合MCI标准； ③生活可以自理； ④年龄在 60 至 75 岁之间； ⑤最近半年内没有规律性的进行每周 3 次以上，每次多于 30min 的各种形式的运动锻炼； ⑥受试者知情同意，自愿参加； 符合以上所有条件者才可以被纳入研究。

Inclusion criteria

Refer to the diagnostic criteria of T2D in the " Clinical Guidelines for the Prevention and Treatment of Type 2 Diabetes in the Elderly in China ( 2022 Edition ) " promulgated by the Diabetes Society of the Chinese Medical Association in 2022. ① FBG ≥ 7.0 mmol / L ; ② 2 h postprandial blood glucose ≥ 11.1 mmol / L ; ③ HbA1c ≥ 6.5 % ; ④ diagnosed as type 2 diabetes or using hypoglycemic drugs. Type 2 diabetes can be diagnosed if any of the above conditions are met. The diagnostic criteria of MCI refer to the ' 2018 Chinese Guidelines for the Diagnosis and Treatment of Dementia and Cognitive Impairment ( 5 ) : Diagnosis and Treatment of Mild Cognitive Impairment ', mainly including : 1 patients or informed persons, or experienced clinicians found cognitive impairment ; 2 There was objective evidence of damage in one or more cognitive function areas ; 3 Complex instrumental daily ability can have slight damage, but maintain independent daily life ability ; 4 has not yet reached the diagnosis of dementia. ① Meet the T2D standard ; ② Meet the MCI criteria ; ③ Life can take care of itself ; ④ Between 60 and 75 years old ; ⑤ In the last six months, there is no regular exercise more than three times a week, more than 30 minutes each time ; ⑥ Subjects informed consent, voluntary participation ; only those who meet all the above conditions can be included in the study.

排除标准：

①空腹血糖＞16.7mmol/L、低血糖反复出现或波动剧烈者、运动性低血糖或血糖小于 4.0mmol/L； ②血压无法控制的高血压患者； ③曾有严重酒精、药物滥用史； ④抑郁引起的认知障碍者； ⑤因中毒或药物等其他原因导致的认知功能障碍者； ⑥有规律运动习惯； ⑦有精神病史，或患有严重失语及视听障碍，抑或是伴有严重脏器衰竭、肌肉骨骼系统疾病、冠心病史、心肌梗死病史、肌肉骨骼系统疾病及其他运动疗法禁忌症者； ⑧正在参加其他临床试验且会影响本研究结局评价者。

Exclusion criteria：

①Fasting blood glucose > 16.7mmol / L, recurrent hypoglycemia or severe fluctuations, exercise-induced hypoglycemia or blood glucose less than 4.0mmol / L ; ② Patients with hypertension whose blood pressure could not be controlled ; ③ Had a history of severe alcohol and drug abuse ; ④ Patients with cognitive impairment caused by depression ; ⑤Patients with cognitive dysfunction caused by poisoning or drugs and other reasons ; ⑥Have regular exercise habits ; ⑦ Patients with a history of mental illness, or suffering from severe aphasia and visual impairment, or accompanied by severe organ failure, musculoskeletal system disease, history of coronary heart disease, history of myocardial infarction, musculoskeletal system disease and other contraindications to exercise therapy ; ⑧ Is participating in other clinical trials and will affect the outcome evaluators of this study.

研究实施时间：

Study execute time：

从 From 2024-05-25 00:00:00至 To 2025-06-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-05-25 00:00:00 至 To 2024-05-31 00:00:00  

干预措施：

Interventions：

组别：

多模式运动组

样本量：

52

Group：

Multi-component exercise group

Sample size：

干预措施：

①准备活动：（每个动作30秒）提膝下压、胯下击掌、对侧触肘、踢毽子、相扑深蹲、内屈腿、叉腰抬腿、下压抬腿、提膝触肘、活动手腕脚腕 ②有氧：（每个动作50秒）上下踏板、高抬腿肘碰膝、v字上下、胯下击掌、单侧3次提膝、并步跳跃、金鸡独立、跑上慢下、上下开合跳、平举高抬腿、提膝上举、交叉后点地、摸脚踝、大鹏展翅、测前后点地（选10个动作，两组，组与组之间休息1-2分钟） ③抗阻：（约20分钟）坐姿平推、坐姿推举、蝴蝶夹胸/背阔训练、二/三头肌训练、大腿前伸、大腿外展、交叉蹬腿、卷腹/顶背训练(液压式循环抗阻训练器完成) ④八段锦：（12分钟）国家体育总局口令版 ⑤放松：（每个动作40秒）颈部拉伸、手臂拉伸、三角肌和肩周拉伸、背部和侧方肌拉伸、腰腿拉伸、侧腰拉伸、大腿前侧拉伸、小腿拉伸 运动控制：佩戴运动手环，采用储备心率百分比法［THR=（HRmax-HRrest）× 预期强度（45%～75%），HRmax=207-0.×年龄］确定参与运动干预老年人的靶心率范围，采用 Brog 主观疲劳感觉量表（rating of preceived exertion, RPE）测量运动疲劳程度。 采用运动进阶的原则，初期运动强度控制在 45%～55% HRmax，运动时间 40-60min；中期运动强度 55%～65%HRmax，运动时间 50～70 min；后期运动强度 65%～75% HRmax，运动时间 50～70 min。每周运动 3 次。

干预措施代码：

Intervention：

1 Preparatory activities : ( 30 seconds for each action ) Knee lifting and pressing, hip hitting, elbow touching on the opposite side, kicking shuttlecock, sumo deep squat, internal flexion of legs, waist lifting, leg pressing and lifting, knee lifting and elbow touching, wrist and ankle moving. 2 Aerobic : ( each action 50 seconds ) up and down the pedal, high leg elbow touch the knee, v word up and down, crotch palm, unilateral three times to lift the knee, step jump, Jinji independence, run up and slow down, up and down jump, flat lift high leg, lift the knee up, cross the back point, touch the ankle, Dapeng wings, measured before and after the point ( select 10 actions, two groups, 1-2 minutes rest between groups ). 3 Resistance : ( about 20 minutes ) sitting flat push, sitting push, butterfly clip chest / back broad training, biceps / triceps training, thigh extension, thigh abduction, cross kick, roll abdomen / back training ( completed by hydraulic cyclic resistance trainer ) 4 Baduanjin : ( 12 minutes ) State General Administration of Sports password version Relaxation : ( 40 seconds for each action ) neck stretching, arm stretching, deltoid and shoulder stretching, back and lateral muscle stretching, waist and leg stretching, side waist stretching, front thigh stretching, calf stretching. Exercise control : wearing exercise bracelet, using reserve heart rate percentage method [ THR = ( HRmax-HRrest ) × expected intensity ( 45 % -75 % ), HRmax = 207-0. × age ] to determine the target heart rate range of the elderly participating in exercise intervention, and using Brog 's rating of preceived exertion ( RPE ) to measure the degree of exercise fatigue. The principle of advanced exercise was adopted. The initial exercise intensity was controlled at 45 % ~ 55 % HRmax, and the exercise time was 40-60 min. The medium-term exercise intensity was 55 % -65 % HRmax, and the exercise time was 50-70 min. The later exercise intensity was 65 % ~ 75 % HRmax, and the exercise time was 50 ~ 70 min. Exercise 3 times a week.

Intervention code：

组别：

健步走组

样本量：

52

Group：

Fitness walking group

Sample size：

干预措施：

由具有 5 年以上教学经验的专业教练带领下进行训练，动作要领如下：在自然行走的基础上，躯干伸直，收腹、挺胸、抬头，随步行速度的加快而肘关节自然弯曲，以肩关节为轴自然前后摆臂，同时腿朝前迈，脚跟先着地，过渡到前脚掌，然后推离地面，每次集中锻炼

干预措施代码：

Intervention：

The training is led by a professional coach with more than 5 years of teaching experience. The action essentials are as follows : on the basis of natural walking, the trunk is stretched, the abdomen is retracted, the chest is straightened, and the head is raised. With the acceleration of walking speed, the elbow joint is naturally bent, and the shoulder joint is used as the axis to swing the arm before and after naturally. At the same time, the legs move forward, the heel touches the ground first, transits to the front sole, and then pushes off the ground.

Intervention code：

组别：

对照组

样本量：

52

Group：

Control group

Sample size：

干预措施：

对照组不参与运动干预，要求其保持原有的日常活动状态。采用国际体力活动量表短卷(IPAQ-SF)评估受试者 1 周内体力活动水平，每 4 周评估 1 次，对照组日常体力活动状态应低于 600METs-min/week。为保障空白对照组受试的权益，拟将该组被试纳入未来研究中的主要运动干预组。

干预措施代码：

Intervention：

The control group did not participate in exercise intervention, requiring them to maintain their original daily activities. The International Physical Activity Questionnaire Short Form ( IPAQ-SF ) was used to evaluate the physical activity level of the subjects within 1 week, once every 4 weeks. The daily physical activity status of the control group should be lower than 600 METs-min / week. In order to protect the rights and interests of the subjects in the blank control group, this group of subjects is proposed to be included in the main exercise intervention group in future research.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 山东 

市(区县)：

  

Country：

China 

Province：

Shandong 

City：

 

单位(医院)：

山东体育学院 

单位级别：

大学 

Institution
hospital：

Shandong Sport University

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

近红外脑功能成像

指标类型：

主要指标

Outcome：

Near infrared brain imaging

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

蒙特利尔认知评估(MoCA)

指标类型：

主要指标

Outcome：

Montreal Cognitive Assessment

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血清生化指标

指标类型：

次要指标

Outcome：

Serum biochemical indexes

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

简易精神状态检查表（MMSE）

指标类型：

主要指标

Outcome：

Mini-Mental State Examination

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

认知功能子域测试

指标类型：

主要指标

Outcome：

Cognitive function subdomain test

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

功能性体适能测试

指标类型：

次要指标

Outcome：

Functional fitness test

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：

血液

组织：

Sample Name：

Blood

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 60 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）：

本次研究被试随机分组序列由专门的统计工作人员采用 SPSS Statistics 20.0 统计软件程序产生，并应用不透光、密闭封信法隐藏随机分组序列。将合格对象按纳入的顺序编号以及 1：1：1 的比例随机分配进入多模式运动组、健步走组和空白对照组。随机序列由课题组专人负责管理，该人员不参与受试者招募、结局评估及统计分析。

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

The random grouping sequence of the subjects in this study was generated by a special statistical staff using SPSS Statistics 20.0 statistical software program, and the random grouping sequence was hidden by opaque and sealed envelope method. The qualified subjects were randomly assigned to the multi-mode exercise group, the brisk walking group and the blank control group according to the order number and the ratio of 1 : 1 : 1. The random sequence is managed by a person in charge of the research group, who is not involved in the recruitment of subjects, outcome assessment and statistical analysis. In this study, single-blind method was used to blind outcome evaluators and statistical analysts.

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：

本研究采用单盲法对结局评价人员及统计分析人员设盲。采用字母 A、B和 C 代替组别，通过 SPSS 20.0 软件设置盲底，对盲底文件设置密码并由随机序列保管员保管。最终数据统计分析完成后，由随机序列保管员揭盲。

Blinding：

The letters A, B and C were used to replace the groups. The blind bottom was set by SPSS 20.0 software, and the password was set for the blind bottom file and kept by the random sequence custodian. After the final data statistical analysis is completed, the random sequence custodian is blinded.

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

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：

无

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

None

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：

  2024-05-17 09:04:10