ChiCTR2400083013 版本V1.0 版本创建时间2024/04/12 17:44:05 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：

 ChiCTR2400083013 

最近更新日期：

Date of Last Refreshed on：

 2024-04-12 17:43:41 

注册时间：

Date of Registration：

 2024-04-12 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

审核意见见邮件并回复 下肢非稳定抗阻训练结合认知训练对老年女性平衡能力的影响研究

Public title：

The influence of lower limbs unstable resistance training combined with cognitive training on balance ability of elderly women

注册题目简写：

English Acronym：

研究课题的正式科学名称：

下肢非稳定抗阻训练结合认知训练对老年女性平衡能力及步态的影响研究

Scientific title：

Impact of integrated cognitive and physical training vs. physical training alone on balance, cognition and gait in elderly women

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：

王亚欣 

研究负责人：

宋小波 

Applicant：

Yaxin Wang 

Study leader：

Xiaobo Song 

申请注册联系人电话：

Applicant telephone：

 +86 136 1346 3092

研究负责人电话：

Study leader's
telephone：

+86 185 0275 8455

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：

 w13613463092@163.com

研究负责人电子邮件：

Study leader's E-mail：

 songxb@ccnu.edu.cn

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：

湖北省武汉市洪山区雄楚大道382号华中师范大学南湖校区

研究负责人通讯地址：

湖北省武汉市洪山区雄楚大道382号华中师范大学南湖校区

Applicant address：

Nanhu Campus, Central China Normal University, 382 Xiongchu Avenue, Hongshan District, Wuhan City, Hubei Province

Study leader's address：

Nanhu Campus, Central China Normal University, 382 Xiongchu Avenue, Hongshan District, Wuhan City, Hubei 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：

华中师范大学

Applicant's institution：

Central China Normal University

研究负责人所在单位：

华中师范大学

Affiliation of the Leader：

Central China Normal 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：

 CCNU-IRB-202310027b

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：

华中师范大学伦理委员会

Name of the ethic committee：

Central China Normal University,Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-10-02 00:00:00

伦理委员会联系人：

张劲夫

Contact Name of the ethic committee：

Jinfu Zhang

伦理委员会联系地址：

湖北省武汉市洪山区雄楚大道382号华中师范大学南湖校区

Contact Address of the ethic committee：

Nanhu Campus, Central China Normal University, 382 Xiongchu Avenue, Hongshan District, Wuhan City, Hubei Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 156 2360 6182

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：

华中师范大学

Primary sponsor：

Central China Normal University

研究实施负责（组长）单位地址：

湖北省武汉市洪山区雄楚大道382号华中师范大学南湖校区

Primary sponsor's address：

Nanhu Campus, Central China Normal University, 382 Xiongchu Avenue, Hongshan District, Wuhan City, Hubei 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)：

湖北

市(区县)：

武汉

Country：

CHINA

Province：

Hubei

City：

Wuhan

单位(医院)：

华中师范大学

具体地址：

湖北省武汉市洪山区雄楚大道382号华中师范大学南湖校区

Institution
hospital：

Central China Normal University

Address：

Nanhu Campus, Central China Normal University, 382 Xiongchu Avenue, Hongshan District, Wuhan City, Hubei Province

经费或物资来源：

华中师范大学(NO. 31101222041 and CCNU22JC004)、中国国家自然科学基金会(NO. 82301791).

Source(s) of funding：

funded by the Central China Normal University (NO. 31101222041 and CCNU22JC004) and the National Natural Science Foundation of China (NO. 82301791).

研究疾病：

平衡能力下降  

Target disease：

balance decline

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：

本研究探讨了综合不稳定阻力训练和认知训练(IRCT)与单纯的不稳定阻力训练(IRT)对老年女性平衡、步态、肌肉力量和认知功能的影响。  

Objectives of Study：

This study investigates the effects of integrated instability resistance training and cognitive training (IRCT) versus isolated instability resistance training (IRT) on balance, gait, muscle strength, and cognitive functions in elderly women.

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）60岁及60岁以上的老年女性； （2）无视、听功能障碍，理解能力正常者； （3）无认知障碍，可以进行独立行走和运动； （4）半年内未接受力量锻炼的老年人； （5）在实验前进行了运动前筛查问卷调查，根据 AHA/ACSM 评估 （6）签约“知情同意书”，自愿参加。

Inclusion criteria

(1) elderly women aged 60 and above; (2) individuals without visual or auditory impairments and with normal understanding abilities; (3) no cognitive impairments, capable of independent walking and exercise; (4) elderly who have not engaged in strength training in the past six months; (5) A pre-exercise screening questionnaire was conducted prior to the experiment, as assessed by the AHA/ACSM; (6) willing to participate in the study.

排除标准：

（1）患有严重疾病的患者和患病刚恢复的患者； （2）患有造成平衡功能损害较严重的神经系统疾病者，如脑卒中等； （3）行走需使用辅助器具者。

Exclusion criteria：

(1) participants with known cardiovascular, metabolic or musculoskeletal diseases, or those who have recently recovered from an illness; (2) individuals with severe neurological diseases affecting balance, such as stroke; (3) those requiring walking aids.

研究实施时间：

Study execute time：

从 From 2023-06-01 00:00:00至 To 2023-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-08-15 00:00:00 至 To 2023-08-31 00:00:00

干预措施：

Interventions：

组别：

下肢非稳定训练结合认知训练

样本量：

 17

Group：

integrated instability resistance training and cognitive training

Sample size：

干预措施：

实验组（N=17）进行8周的下肢非稳定抗阻训练结合认知训练（双任务训练）

干预措施代码：

 IRCT

Intervention：

The experimental group (N=17) underwent 8 weeks of lower extremity unstable resistance training combined with cognitive training (dual task training)

Intervention code：

组别：

下肢非稳定训练

样本量：

 17

Group：

versus isolated instability resistance training

Sample size：

干预措施：

对照组（N=17）进行8周的下肢非稳定抗阻训练训练

干预措施代码：

 IRT

Intervention：

The control group (N=17) underwent 8 weeks of unsteady resistance training for lower limbs (single task training).

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖北 

市(区县)：

  

Country：

China

Province：

Hubei

City：

单位(医院)：

 华中师范大学 

单位级别：

 大学 

Institution
hospital：

Central China Normal University

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

闭眼单足立单任务测试

指标类型：

主要指标

Outcome：

Step experiment with eyes closed

Type：

Primary indicator

测量时间点：

测量方法：

受试者直立准备，双手放于两侧。当测试者说开始后，受试者抬起一只脚，抬离高度需离地面约10cm。当受试者的抬起脚落下或支撑脚移动位置等，测试结束。测试2次取最高值。

Measure time point of outcome：

Measure method：

Subject stands upright with hands at sides. When the tester says "start", the subject raises one foot and lifts it about 10cm off the ground. The test ends when the subject's lifting foot falls or the supporting foot moves into position. Test twice to take the highest value.

指标中文名：

闭眼踏步实验

指标类型：

主要指标

Outcome：

Step experiment with eyes closed

Type：

Primary indicator

测量时间点：

测量方法：

受试者闭眼站在步态分析仪的测试区域内，电脑播放“滴滴”的声音（频率为120次/min），当测试者说开始后，受试者需要跟随声音的节奏进行踏步30s。电脑记录双脚偏移的平均值，偏移距离越小，老年人的动态平衡能力越好。

Measure time point of outcome：

Measure method：

The subjects stood in the test area of the gait analyzer with their eyes closed, and the computer played the sound of "drops" (the frequency was 120 times /min). When the tester said "start", the subjects needed to follow the rhythm of the sound for 30s. The computer recorded the average deviation of the feet, and the smaller the deviation distance, the better the dynamic balance ability of the elderly.

指标中文名：

起立行走测试

指标类型：

主要指标

Outcome：

The timed up and go test

Type：

Primary indicator

测量时间点：

测量方法：

当测试者说开始后，受试者在不借助扶手情况下从椅子上站起。站稳后往前行走，走到3m处的终点位置转身，双脚都需要过标志线。然后原路返回，走回到椅子前坐下。测试2次取最小值，起立行走测试时间越短证明平衡能力越好

Measure time point of outcome：

Measure method：

When the tester says go, the subject gets up from the chair without the help of armrests. Stand firm and walk forward, walk to the end position at 3m and turn, both feet need to cross the sign line. Then he retraced his steps, walked back to his chair and sat down. The minimum value was taken for two tests. The shorter the standing and walking test time was, the better the balance ability was

指标中文名：

起立行走测试与认知任务相结合的测试

指标类型：

主要指标

Outcome：

TUGT combined with a cognitive task

Type：

Primary indicator

测量时间点：

测量方法：

受试者在进行起立行走测试的同时完成（100-3）数减3的数学计算，记录测试所用时间，测试2次取最小值。

Measure time point of outcome：

Measure method：

The subjects completed the mathematical calculation of (100-3) number minus 3 while performing the standing and walking test. The time spent in the test was recorded, and the minimum value was taken in the test twice.

指标中文名：

起立行走与运动任务相结合的测试

指标类型：

主要指标

Outcome：

TUGT combined with a motor task

Type：

Primary indicator

测量时间点：

测量方法：

用惯用手持一次性水杯，水杯里面放4/5的水量，在保证水杯中的水不洒的前提下，受试者完成起立行走测试，记录测试所用时间，测试2次取最小值。

Measure time point of outcome：

Measure method：

With a disposable water cup in hand, the water cup is filled with 4/5 of water. Under the premise of ensuring that the water in the cup is not spilled, the subjects complete the standing and walking test, record the test time, and take the minimum value for two tests.

指标中文名：

数字广度测试

指标类型：

次要指标

Outcome：

The digit span test

Type：

Secondary indicator

测量时间点：

测量方法：

用于评估老年人认知功能中的短时记忆能力。测试者向受试者说一组数字，让受试者重复说出，从2个数字开始，回答正确后依次增多。测试类型包括正向重复数字、反向重复数字、对数字排序测试。记录测试者最大能力重复数字的个数，三类测试相加的数值为受试者的数字广度，数值越大，老年人的短时记忆能力越强。

Measure time point of outcome：

Measure method：

To assess short-term memory in cognitive function in older adults. The tester tells the subject a set of numbers and asks the subject to repeat them, starting with two numbers and increasing as they answer correctly. Test types include forward repeating numbers, reverse repeating numbers, and ordering numbers. The maximum number of repeated numbers was recorded. The sum value of the three types of tests was the number breadth of the subjects. The larger the value, the stronger the short-term mem

指标中文名：

连线测试

指标类型：

次要指标

Outcome：

Trail making test

Type：

Secondary indicator

测量时间点：

测量方法：

用于评估老年人认知功能中的注意力，采用Alexandre等于2015年编制TMT-A测试进行注意力评估。在一张A4纸上有1-25个数字，受试者需要从1连到2连到3，依次练到25，记录受试者完成测试的时间。

Measure time point of outcome：

Measure method：

To assess attention in cognitive function in older adults, attention was assessed using the MTT-A test prepared by Alexandre Equals in 2015. There are 1-25 numbers on a piece of A4 paper, and the subject needs to practice from 1 to 2 to 3, in turn, to 25, and record the time for the subject to complete the test.

指标中文名：

色卡测试

指标类型：

次要指标

Outcome：

Stroop color and word test

Type：

Secondary indicator

测量时间点：

测量方法：

用于评估老年人认知功能中的抗干扰能力。在一张A4纸上有45汉字，汉字所代表的但词义与该汉字的颜色不一定一致。受试者要读出文字的颜色而不是文字的意思，共45个测试词，记录受试者完成所有测试词的耗时。

Measure time point of outcome：

Measure method：

To assess anti-interference ability in cognitive function in older adults. There are 45 Chinese characters on a piece of A4 paper, and the meaning of the Chinese character is not necessarily the same as the color of the Chinese character. The subjects were asked to read out the color of the words instead of the meaning of the words, a total of 45 test words, and the time taken for the subjects to complete all the test words was recorded.

指标中文名：

数字符号测试

指标类型：

次要指标

Outcome：

Digit symbol substitution test

Type：

Secondary indicator

测量时间点：

测量方法：

用于评估老年人的学习能力、灵活性和处理信息的速度。在一张A4纸上的上方有一个表格，表格里有1-9个数字，这9个数字分别对应9个符号。纸的下方有数行没有规律的数字，受试者需要根据不同的数字找到对应的符号，并填写至符号下方的表格中。共测试90s,计算填写正确的符号。

Measure time point of outcome：

Measure method：

Used to assess older adults' ability to learn, flexibility, and speed of processing information. At the top of a piece of A4 paper is a table with 1-9 numbers, each of which corresponds to 9 symbols. There are several lines of irregular numbers at the bottom of the paper. Subjects need to find corresponding symbols according to different numbers and fill in the form below the symbols. Total test 90s, calculate fill in the correct symbol.

指标中文名：

下肢肌肉力量测试

指标类型：

次要指标

Outcome：

30-Second chair stand test

Type：

Secondary indicator

测量时间点：

测量方法：

受试者在椅子上，双手交叉放在胸前，不可以靠后背。当测试者说开始后，受试者开始起立-坐下依次进行，测试30s，要求在安全的前提下，越快越好。共测试2次，取两次测试的最大值。

Measure time point of outcome：

Measure method：

Subject in a chair, hands crossed in front of the chest, not back. When the tester said "start", the subject began to stand up and sit down successively, and the test was 30 seconds, the faster the better under the premise of safety. Test twice in total, take the maximum value of the two tests.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

None

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：

结束

/Completed

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）：

将34名老年女性的姓名一一编号，一位受试者对应一个编号，然后将编号放在Excel的第一列，随后用Excel的RAND函数进行随机分组，将34名老年人分为两组。

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

The names of 34 elderly women were numbered one by one, one for each subject, and the numbers were placed in the first column of Excel, and then the RAND function of Excel was used for random grouping, and the 34 elderly people were divided into two groups.

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：

无

Blinding：

None

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）：

临床试验公共管理平台ResMan (www.medresman.org.cn)

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

Clinical trial public management platform ResMan (www.medresman.org.cn)

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：

研究团队为每位纳入本研究的受试者分配一个受试者编号。在数据收集过程中，受试者姓名将使用编号代替以保护受试者隐私。唯一可将受试者与其所获编号联系起来的文件将由研究负责人一人保管。所收集数据以excel表格形式储存，不使用电子采集和管理系统

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

The research team assigned a subject number to each participant enrolled in the study. Subject names will be replaced by numbers during data collection to protect subject privacy. The only documents linking subjects to their assigned numbers will be kept by the study leader alone. The collected data is stored in excel form without the use of electronic collection and management system

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：

  2024-04-12 17:43:41