中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2400088822
最近更新日期： Date of Last Refreshed on：	2024-08-27 15:35:04
注册时间： Date of Registration：	2024-08-27 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	高海拔地区藏汉儿童青少年心肺耐力和执行功能的发育特征及其运动干预研究
Public title：	Developmental Characteristics of Cardiorespiratory Endurance and Executive Function in Tibetan and Chinese Children and Adolescents at High Altitude and Their Exercise Intervention Research
注册题目简写：
English Acronym：
研究课题的正式科学名称：	高海拔地区藏汉儿童青少年心肺耐力和执行功能的发育特征及其运动干预研究
Scientific title：	Developmental Characteristics of Cardiorespiratory Endurance and Executive Function in Tibetan and Chinese Children and Adolescents at High Altitude and Their Exercise Intervention Research
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：	毕存箭	研究负责人：	尹小俭
Applicant：	Bi Cunjian	Study leader：	Yin Xiaojian
申请注册联系人电话： Applicant telephone：	+86 180 1922 9729	研究负责人电话： Study leader's telephone：	+86 135 1215 9036
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：	cjbi1985@126.com	研究负责人电子邮件： Study leader's E-mail：	xjyin@tyxx.ecnu.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：	上海市闵行区东川路500号华东师范大学体育与健康学院	研究负责人通讯地址：	上海市闵行区东川路500号华东师范大学体育与健康学院
Applicant address：	School of Physical Education and Health, East China Normal University, No. 500 Dongchuan Road, Minhang District, Shanghai, China	Study leader's address：	School of Physical Education and Health, East China Normal University, No. 500 Dongchuan Road, Minhang District, Shanghai, China
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：	华东师范大学体育与健康学院
Applicant's institution：	School of Physical Education and Health, East China Normal University,
研究负责人所在单位：	华东师范大学体育与健康学院
Affiliation of the Leader：	School of Physical Education and Health, East 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：	HR078-2020	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：	华东师范大学人体实验伦理委员会
Name of the ethic committee：	University Committee on Human Research Protection
伦理委员会批准日期： Date of approved by ethic committee：	2020-05-04 00:00:00
伦理委员会联系人：	王群
Contact Name of the ethic committee：	Wang Qun
伦理委员会联系地址：	中国上海中山北路3663
Contact Address of the ethic committee：	3663 Zhongshan Road North, Shanghai
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 21 5434 2964	伦理委员会联系人邮箱： Contact email of the ethic committee：	qunwang@admin.ecnu.edu.cn

研究实施负责（组长）单位：

华东师范大学体育与健康学院

Primary sponsor：

School of Physical Education and Health, East China Normal University,

研究实施负责（组长）单位地址：

上海市闵行区东川路500号华东师范大学体育与健康学院

Primary sponsor's address：

School of Physical Education and Health, East China Normal University, No. 500 Dongchuan Road, Minhang District, Shanghai, 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)：	上海	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	华东师范大学体育与健康学院	具体地址：	上海市闵行区东川路500号华东师范大学体育与健康学院
Institution hospital：	School of Physical Education and Health, East China Normal University,	Address：	School of Physical Education and Health, East China Normal University, No. 500 Dongchuan Road, Minhang District, Shanghai,

经费或物资来源：

华东师范大学体育与健康学院

Source(s) of funding：

School of Physical Education and Health, East China Normal University,

研究疾病：

执行功能

Target disease：

executive function

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：

探索性研究/预试验

Study phase：

0

研究设计：

单臂

Study design：

Single arm

研究目的：

本研究通过测试了解高海拔地区藏汉儿童青少年心肺耐力的差异，探讨心肺耐力对高海拔地区藏汉儿童青少年执行功能的影响。同时，了解高海拔地区儿童青少年心肺耐力与执行功能之间的关系。此外，本研究分析心肺耐力对执行功能的促进作用，并通过运动干预促进心肺耐力，探讨心肺耐力的改变对执行功能的影响。

Objectives of Study：

This study was conducted to understand the differences in cardiorespiratory endurance between Tibetan and Chinese children and adolescents at high altitude through testing, and to investigate the effects of cardiorespiratory endurance on executive functioning of Tibetan and Chinese children and adolescents at high altitude. Also, to understand the relationship between cardiorespiratory endurance and executive function in children and adolescents at high altitude. In addition, this study analyzes the contribution of cardiorespiratory endurance to executive function, and promotes cardiorespiratory endurance through exercise intervention to explore the effects of changes in cardiorespiratory endurance on executive function.

药物成份或治疗方案详述：

运动干预方案： 1）1-4周体育游戏周一：腿与手臂力量发展参考动作：以提高腿部和手臂力量为主的游戏和球类运动，如游戏追逐跑、同伴背着追逐跑、下蹲速度比赛等。每个项目进行3-5次。周三：核心力量参考动作：平板支撑*3*30秒；侧面支撑*3*30秒（两侧）；交替伸腿 *3（每侧腿15次）；卷腹*3。平板支撑游戏比赛。周五：核心力量参考动作：侧卧举腿 *3（两侧）；两头起*3；俯卧挺身 *3；跪撑举腿 *3；臀桥*3*30秒。侧卧位球类传递游戏比赛。每周一、三、五在进行游戏力量为主的锻炼后进行慢跑的心肺耐力锻炼和游戏。 2）5-8周周一：臀腿与核心力量参考动作：臀桥*4*60秒；徒手深蹲*4*60秒；侧面支撑*3*60秒（两侧）；俯卧挺身 *3；卷腹*3。锻炼结合同伴的游戏锻炼进行。周三：核心力量参考动作：平板支撑*3*60秒；侧卧举腿 *4（两侧）；交替伸腿 *3（每侧腿15次）；跪撑举腿 *3。同伴相互鼓励的游戏锻炼。周五：手臂与核心力量参考动作：俯卧撑*4；推小车*4*10米；仰卧举腿*4（两侧腿）；两头起*4。每周一、三、五在力量训练结束后进行心肺耐力追逐的游戏比赛。 3）9-12周周一：手臂、腿与核心参考动作：1.高位俯卧撑；2.徒手深蹲；3.平板支撑（60秒）；4.交替伸腿。从 1 到 4 的依次完成并循环 3 回合。并进行相应的游戏比赛，提高锻炼积极性。周三：手臂、腿与核心参考动作：1.推小车（10米）；2.单腿蹲（每侧30秒）；3.侧卧举腿（两侧）；4.俯卧挺身。从 1 到 4 的依次完成并循环 3回合。周五：手臂、腿与核心参考动作：1.倒立（60秒）；2.单腿下蹲触箱式练习；3.两头起；4.俯跪撑举腿；5.臀桥。从 1 到 5 的依次完成并循环 3 回合。每周一、三、五在力量训练结束后进行心肺耐力游戏锻炼。 3. 任务耗时和总耗时：（1）测量20米往返跑耗时15分钟，两次累计30分钟；（2）测量执行功能耗时20分钟，两次累计40分钟；（3）运动干预累计36小时。总耗时：37小时10分钟。报酬：无报酬。

Description for medicine or protocol of treatment in detail：

Exercise intervention program: 1) 1-4 weeks Physical activity games Monday: leg and arm strength development Reference actions: games and ball games that focus on improving leg and arm strength, such as game chase runs, peer back chase runs, and squat speed races. Each program is performed 3-5 times. Wednesday: Core Strength Reference movements: Plank support *3*30 seconds; Side support *3*30 seconds (both sides); Alternating leg extensions *3 (15 reps for each side of the leg); Curls *3. Plank support game competition. Friday: Core Strength Reference Moves: Side Lying Leg Raises *3 (both sides); Two Head-Ups *3; Prone Jerk *3; Kneeling Leg Raises *3; Glute Bridges *3 * 30 sec. Side Lying Ball Passing Game Competition. Cardiorespiratory endurance workout and games of jogging on Mondays, Wednesdays, and Fridays after a game strength-based workout. 2) Weeks 5-8 Monday: Glute & Leg & Core Strength Reference movements: glute bridges *4*60 seconds; unassisted squats *4*60 seconds; lateral supports *3*60 seconds (both sides); push-ups *3; curls *3. Workout is performed in conjunction with a game-based workout with a partner. Wednesday: Core Strength Movements: Planks *3*60 seconds; Side Leg Raises *4 (both sides); Alternating Leg Extensions *3 (15 reps on each leg); Kneeling Leg Raises *3. Workout is combined with a peer-encouraged game. Friday: Arm and Core Strength Reference movements: push-ups *4; push cart *4*10 meters; supine leg raises *4 (both sides of the leg); double head ups *4. Game competition of cardio endurance chase every Monday, Wednesday and Friday at the end of strength training. 3) 9-12 weeks Monday: Arms, Legs & Core Reference movements: 1. High push-ups; 2. Unassisted deep squats; 3. Planks (60 seconds); 4. Alternating leg extensions. Complete and circulate 3 rounds from 1 to 4 in sequence. Play games to increase motivation. Wednesday: Arms, Legs & Core Reference movements: 1. push cart (10 meters); 2. one-legged squat (30 seconds on each side); 3. lateral leg raises (both sides); 4. push-ups. Complete and cycle from 1 to 4 in order for 3 rounds. Friday: Arms, Legs & Core Movements: 1. Handstand (60 seconds); 2. Single-leg squat to box; 3. Double overhead; 4. Kneeling leg raises; 5. Glute bridges. Complete from 1 to 5 in order and cycle for 3 rounds. Cardiorespiratory endurance games will be performed on Mondays, Wednesdays, and Fridays at the end of strength training. 3. Task elapsed time and total elapsed time: (1) Measurement of 20-meter round-trip running time consumed was 15 minutes, with two accumulations of 30 minutes; (2) Measurement of executive functioning took 20 minutes, with two cumulative 40-minute sessions; (3) 36 cumulative hours of exercise intervention. Total time spent: 37 hours and 10 minutes. Compensation: no compensation.

纳入标准：

Inclusion criteria

排除标准：

年龄：小于10岁，大于12岁；母语：无须排除，但被试必须能够熟练使用普通话与研究者进行交流；疾病状况：有心脏病史，有肺部疾病史，有肌肉骨骼疾病史，有轻度活动就有胸闷、头痛、头晕等不适症状史等病史，躯体有残疾，心理不健康。另外，未能通过国家体质健康测试者；受教育程度：测试所在地非中学的在读学生须被排除。

Exclusion criteria：

Age: less than 10 years old and more than 12 years old; mother tongue: no exclusion was necessary, but subjects had to be able to communicate with the researcher proficiently in Mandarin; disease status: history of heart disease, history of lung disease, history of musculoskeletal disorders, history of uncomfortable symptoms such as chest tightness, headache, and dizziness with mild activity, etc., physical disability, and mental ill health. In addition, those who failed the national physical fitness test. Educational attainment: students not enrolled in primary or secondary schools in the location of the test must be excluded.

研究实施时间：

Study execute time：

从 From 2020-05-04 00:00:00至 To 2022-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2021-03-01 00:00:00 至 To 2021-07-20 00:00:00

干预措施：

Interventions：

组别：	干预组	样本量：	120
Group：	Intervention group	Sample size：	120
干预措施：	运动干预	干预措施代码：
Intervention：	Exercise intervention	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	西藏	市(区县)：	拉萨市
Country：	China	Province：	Tibet	City：	Lhasa
单位(医院)：	拉萨市第八中学	单位级别：	中学
Institution hospital：	Lhasa No. 8 Middle School	Level of the institution：	Middle School

测量指标：

Outcomes：

指标中文名：	（1）运动干预前后进行20米往返跑测试；（2）运动干预前后使用计算机机房进行执行功能测试；	指标类型：	主要指标
Outcome：	(1) A 20-meter round-trip running test before and after the exercise intervention; (2) Executive function tests using a computer room before and after the exercise intervention;	Type：	Primary 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：	NO	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：

结束

/Completed

年龄范围：

Participant age：

最小 Min age		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）：

由负责干预的教师采用随机编码的方式进行随机抽取.

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

Randomization was carried out by the teacher in charge of the intervention using random coding.

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：
Blinding：

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）：	2024-08-17，网络平台EDC上传原始数据，http://www.medresman.org.cn/uc/sindex.aspx
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	2024-08-17, Web platform EDC uploads raw data, http://www.medresman.org.cn/uc/sindex.aspx
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：	1.所有数据以匿名的方式收集。被试的名字，或其它可识别身份的信息（如学号），不会出现在任何数据中。而是使用数字编号区分被试。 a.原始数据储存在主试电脑硬盘里。 b.分析数据储存在主试电脑硬盘里。 2.主试电脑有密码保护，主试与指导老师可接触分析数据。 3.所有数据和被试知情书储存至少3年。项目完成后，数据将被储存保留。所有数据都是匿名的，以上1a和1b中描述的方式储存保留。知情同意书以3中描述的方式分离储存保留。知情同意书上之后姓名而没有编号，与试验数据分离后便不可再识别学生身份。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	1. All data are collected on an anonymous basis. Subjects' names, or other identifying information (e.g., school number), do not appear in any of the data. Instead, numerical numbers are used to distinguish subjects. a.Raw data are stored on the hard drive of the master subject's computer. b. The analyzed data is stored on the hard drive of the master computer. 2. The master computer is password-protected so that the master and instructor have access to the analyzed data. 3. All data and the Subject Informational Letter will be stored for at least 3 years. The data will be stored and retained after completion of the project. All data are anonymized and stored for retention in the manner described in 1a and 1b above. Informed consent forms are stored separately and retained in the manner described in 3. The informed consent form is followed by a name without a number, and when separated from the trial data, the student is no longer identifiable.
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：	2024-08-27 15:34:58