The Efficacy of Patting Gong in Chinese Martial Arts for Improving Bone Health: Evidences from Dual - Methodological Research

注册号:

Registration number:

ITMCTR2025000380

最近更新日期:

Date of Last Refreshed on:

2025-02-21

注册时间:

Date of Registration:

2025-02-21

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

从武术到健康维护:探索拍打功对人体骨密度的影响

Public title:

The Efficacy of Patting Gong in Chinese Martial Arts for Improving Bone Health: Evidences from Dual - Methodological Research

注册题目简写:

English Acronym:

研究课题的正式科学名称:

从武术到健康维护:探索拍打功对人体骨密度的影响

Scientific title:

From Martial Arts to Health Maintenance:Exploring the Effects of Patting Gong on Human Bone Mineral Density

研究课题的正式科学名称简写:

Scientific title acronym:

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:

常金鑫

研究负责人:

李印东

Applicant:

Jinxin Chang

Study leader:

Yindong Li

申请注册联系人电话:

Applicant telephone:

18845045407

研究负责人电话:

Study leader's telephone:

18514658766

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:

changxin0720@163.com

研究负责人电子邮件:

Study leader's E-mail:

2581453060@qq.com

申请单位网址(自愿提供):

Study leader's 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:

山西省太原市小店区山西大学

研究负责人通讯地址:

北京市海淀区北京体育大学

Applicant address:

Shanxi University Xiaodian District Taiyuan City Shanxi Province China

Study leader's address:

Beijing Sports University Haidian District Beijing

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:

山西大学

Applicant's institution:

Shanxi University

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

2024134H

伦理委员会批件附件:

Approved file of Ethical Committee:

View

批准本研究的伦理委员会名称:

北京体育大学运动科学实验伦理委员会

Name of the ethic committee:

Experimental Ethics Committee of Exercise Science Beijing Sport University

伦理委员会批准日期:

Date of approved by ethic committee:

2024/1/3 0:00:00

伦理委员会联系人:

梅涛

Contact Name of the ethic committee:

Tao Mei

伦理委员会联系地址:

北京市海淀区北京体育大学

Contact Address of the ethic committee:

Beijing Sports University Haidian District Beijing

伦理委员会联系人电话:

Contact phone of the ethic committee:

010 - 62989303

伦理委员会联系人邮箱:

Contact email of the ethic committee:

mt5345916@163.com

研究实施负责(组长)单位:

北京体育大学

Primary sponsor:

Beijing Sports University

研究实施负责(组长)单位地址:

北京市海淀区北京体育大学

Primary sponsor's address:

Beijing Sports University Haidian District Beijing

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京市

市(区县):

Country:

china

Province:

Beijing

City:

单位(医院):

北京体育大学

具体地址:

北京市海淀区北京体育大学

Institution
hospital:

Beijing Sports University

Address:

Beijing Sports University Haidian District Beijing

经费或物资来源:

自筹经费

Source(s) of funding:

self-financing

研究疾病:

骨质疏松

研究疾病代码:

Target disease:

osteoporosis

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段:

Study phase:

其它

Others

研究目的:

随着全球人口老龄化趋势的加剧,骨质疏松症已成为一个突出的公共卫生问题。本研究旨在通过随机对照试验和横断面观察研究,探讨中国武术拍打功与人体骨骼健康的关系,从而为预防骨质疏松症提供科学依据。

Objectives of Study:

The escalating global trend of population aging has elevated osteoporosis to a prominent public health issue. This study aimed to explore the relationship between Chinese Martial Arts Patting Gong and human bone health through a randomized controlled trial and a cross-sectional observational study thereby providing a scientific basis for osteoporosis prevention.

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:于北京体育大学选取了50名男性受试者。这些受试者年龄均处于18 - 30周岁区间,且除日常活动外,并无任何体育运动习惯。随后,将这50名受试者随机分为两组:武术拍打功实验组(标记为P组,n = 25)与普通对照组(标记为C组,n = 25)。 2:本研究通过当地社区与公园,另行招募了50名男性受试者,年龄均在45周岁以上。 MP 组(n = 25),纳入标准为持续练习武术拍打功三年以上。 MC 组(n = 25),纳入标准为无体育运动习惯的中老年人。

Inclusion criteria

Fifty male subjects were selected from Beijing Sport University. These subjects were all aged between 18 and 30 years old and they had no sports habits except for daily activities. Subsequently these 50 subjects were randomly divided into two groups: the Chinese Martial Arts Patting Gong experimental group (marked as Group P n = 25) and the general control group (marked as Group C n = 25). In this study 50 male subjects were additionally recruited through local communities and parks. All of them were over 45 years old. For the MP group (n = 25) the inclusion criteria were that the subjects had been practicing Chinese Martial Arts Patting Gong continuously for more than three years. For the MC group (n = 25) the inclusion criteria were that the subjects were middle-aged and elderly people without sports habits.

排除标准:

个体正在服用可能影响骨密度和骨矿盐含量的药物、有已知骨骼代谢疾病或结构异常的个体、患有可能影响骨代谢的严重慢性疾病、最近接受过放射性治疗或接受放射性检查、无法遵守研究要求的个体。

Exclusion criteria:

Individuals who are taking medications that may affect bone mineral density and bone mineral content individuals with known skeletal metabolic diseases or structural abnormalities individuals suffering from severe chronic diseases that may affect bone metabolism individuals who have recently received radiotherapy or undergone radioactive examinations and individuals who are unable to comply with the requirements of the study. AI

研究实施时间:

Study execute time:

From 2024-01-03

To      2025-01-03

征募观察对象时间:

Recruiting time:

From 2024-01-03

To      2025-01-03

干预措施:

Interventions:

组别:

中国武术拍打功实验组

样本量:

25

Group:

Group P

Sample size:

干预措施:

P 组参与者接受为期 52 周的拍打功训练,每周四节课,每节课 30 分钟。在此期间,他们被要求不得进行任何其他体育活动。

干预措施代码:

Intervention:

Participants in Group P underwent 52 weeks of Patting Gong training four sessions per week of 30 minutes each. During this period they were asked not to engage in any other physical activity.

Intervention code:

组别:

普通对照组

样本量:

25

Group:

Group C

Sample size:

干预措施:

C 组的参与者既没有接受拍打功训练,也没有参加任何其他形式的体育活动。

干预措施代码:

Intervention:

The participants in Group C neither received Patting Gong training nor participated in any other forms of physical activities.

Intervention code:

组别:

长期拍打功练习中老年组

样本量:

25

Group:

Group MP

Sample size:

干预措施:

无干预

干预措施代码:

Intervention:

No measure

Intervention code:

组别:

无运动习惯中老年组

样本量:

25

Group:

Group MC

Sample size:

干预措施:

无干预

干预措施代码:

Intervention:

No measure

Intervention code:

样本总量 Total sample size : 100

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

china

Province:

Beijing

City:

单位(医院):

北京体育大学

单位级别:

正厅级单位

Institution/hospital:

Beijing Sports University

Level of the institution:

departmental level (e.g. office)

测量指标:

Outcomes:

指标中文名:

骨矿盐

指标类型:

主要指标

Outcome:

Bone Mineral Content

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

骨密度

指标类型:

主要指标

Outcome:

Bone Mineral Density

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:

无需采集

组织:

Sample Name:

No collection required

Tissue:

人体标本去向

其它

说明

Fate of sample 

Others

Note:

征募研究对象情况:

结束

Completed

年龄范围:

最小 18
Min age years
最大 70
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男性

Male

随机方法(请说明由何人用什么方法产生随机序列):

在本研究中,随机方法的设计旨在确保分组的科学性与公正性。对于 50 名 18 - 30 岁的久坐男性,随机分组由不参与干预实施与结果评估的专业统计人员负责。采用计算机软件 SPSS 进行随机化操作,运用其随机数字生成功能产生随机序列。具体步骤为,先对这 50 名男性从 1 到 50 依次编号,然后在 SPSS 中通过随机数字生成程序,生成 50 个介于 1 到 2 之间的随机整数。规定随机数字 1 对应中国武术拍打功实验组(Group P),随机数字 2 对应对照组(Group C)。为防止分组过程中可能出现的偏倚,采用分配隐藏措施,将生成的随机分组结果录入密封的电子文档,在分组时由研究负责人解密,确保分组的随机性和客观性,从而最大程度减少人为因素对研究结果的干扰,保证两组在初始状态下具有良好的可比性,为后续研究结果的可靠性奠定基础 。

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

In this study the randomisation method was designed to ensure the scientific and impartiality of the groups. For 50 sedentary males aged 18 - 30 years the randomisation was carried out by professional statisticians who were not involved in the implementation of the intervention and evaluation of the results. Randomisation was carried out using the computer software SPSS using its random number generator function to produce a random sequence. The specific steps were as follows: first the 50 men were numbered from 1 to 50 and then 50 random integers between 1 and 2 were generated by the random number generation programme in SPSS. Random number 1 corresponded to the experimental group of Chinese Martial Arts Patting Gong (Group P) and random number 2 corresponded to the control group (Group C). In order to prevent possible bias in the grouping process the random grouping results were recorded into a sealed electronic file which was decrypted by the researcher in charge of the study to ensure the randomness and objectivity of the grouping thus minimising the interference of human factors on the results of the study and ensuring that the two groups were initially comparable to each other thus laying the foundation for the reliability of the results of the subsequent study.

盲法:

Blinding:

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):

由于与受试者签订了知情同意书和保密协议,本研究原始数据不做公开。

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

Due to the informed consent and confidentiality agreements signed with the subjects the raw data of this study are not made public.

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:

病例记录表(CRF)设计: 本研究紧密围绕研究目的确定 CRF 记录内容。在探究拍打功对不同部位骨骼 BMD 和 BMC 的影响,CRF 详细记录参与者基本信息、拍打功训练细节(如频率、力度、每次训练部位侧重),以及各部位 BMD 和 BMC 测量数据。纳入所有对研究结果有影响的关键变量。除上述信息外,还可能包括参与者日常饮食(钙摄入情况)、生活习惯(如吸烟、饮酒)、既往病史等,因为这些因素可能干扰拍打功与骨骼健康关系的研究结果。

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

Case Record Form (CRF) Design: The present study closely centred on the research objectives to determine the content of CRF records. In exploring the effects of Patting Gong on BMD and BMC in different parts of the skeleton the CRF recorded in detail the participants' basic information details of the Patting Gong training (e.g. frequency intensity and focus of each training session) as well as BMD and BMC measurements for each part of the skeleton. All key variables that have an impact on study outcomes are included. In addition to the above information participants' daily diet (calcium intake) lifestyle habits (e.g. smoking alcohol consumption) and past medical history may also be included as these factors may interfere with the results of the study on the relationship between Patting Gong and bone health.

数据管理委员会:

Data Managemen Committee:

No

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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