ChiCTR2500110161 版本V1.0 版本创建时间2025/10/09 11:16:15 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：

ChiCTR2500110161 

最近更新日期：

Date of Last Refreshed on：

2025-10-09 11:15:46 

注册时间：

Date of Registration：

2025-10-09 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于普拉提器械的盆腹联合训练对于产后腹直肌分离的干预效果研究

Public title：

Effect of Combined Pelvic and Abdominal Training Using Pilates Equipment on Postpartum Diastasis Recti Abdominis

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于普拉提器械的盆腹联合训练对于产后腹直肌分离的干预效果研究

Scientific title：

Effect of Combined Pelvic and Abdominal Training Using Pilates Equipment on Postpartum Diastasis Recti Abdominis

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：

朱钊颖 

研究负责人：

朱钊颖 

Applicant：

Zhaoying Zhu 

Study leader：

Zhaoying Zhu 

申请注册联系人电话：

Applicant telephone：

+86 152 1045 7791

研究负责人电话：

Study leader's telephone：

+86 152 1045 7791

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：

azhuzhaoying@163.com

研究负责人电子邮件：

Study leader's E-mail：

azhuzhaoying@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：

北京市海淀区信息路48号

研究负责人通讯地址：

北京市海淀区信息路48号

Applicant address：

No. 48, Information Road, Haidian District, Beijing, China

Study leader's address：

No. 48, Information Road, Haidian District, Beijing, 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：

北京体育大学

Applicant's institution：

Beijing Sport University

研究负责人所在单位：

北京体育大学

Affiliation of the Leader：

Beijing 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：

2025312H

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：

北京体育大学运动科学实验伦理委员会

Name of the ethic committee：

Ethics Committee for Sport Science Experiments of Beijing Sport University

伦理委员会批准日期：

Date of approved by ethic committee：

2025-07-10 00:00:00

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：

北京市海淀区信息路48号

Contact Address of the ethic committee：

No. 48, Information Road, Haidian District, Beijing, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 10 6298 9306

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：

北京体育大学康复医学与理疗学教研室

Primary sponsor：

Department of Rehabilitation Medicine and Physical Therapy, Beijing Sport University

研究实施负责（组长）单位地址：

北京市海淀区信息路48号

Primary sponsor's address：

No. 48, Information Road, Haidian District, Beijing, 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)：

北京

市(区县)：

北京

Country：

China

Province：

Beijing

City：

Beijing

单位(医院)：

北京体育大学

具体地址：

北京市海淀区信息路48号

Institution
hospital：

Beijing Sport University

Address：

No. 48, Information Road, Haidian District, Beijing, China

经费或物资来源：

自筹经费

Source(s) of funding：

Self-funded

Target disease：

Postpartum Diastasis Recti Abdominis

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：

腹直肌分离是孕期及产后的常见问题，可引起女性腰痛、盆腔功能障碍、身体形象焦虑、性生活障碍等一系列问题。运动疗法是目前治疗腹直肌分离的推荐保守方法，普拉提运动的器械及运动理念，很好的将抗阻训练、稳定训练、呼吸训练、深层核心肌群训练结合。本研究通过进一步的实验探究，研究基于器械的普拉提盆腹联合训练对于产后DRA的干预效果。  

Objectives of Study：

Diastasis Recti Abdominis (DRA) is a common condition during pregnancy and the postpartum period, which can lead to a series of issues such as low back pain, pelvic floor dysfunction, body image anxiety, and sexual dysfunction in women. Exercise therapy is currently the recommended conservative management approach for DRA. The apparatus and principles of Pilates effectively integrate resistance training, stabilization exercises, breathing techniques, and deep core muscle engagement. This study aims to further investigate, through experimental exploration, the interventional effects of apparatus-based combined pelvic and abdominal Pilates training on postpartum DRA.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.20-45岁产后一年以上的女性，剖宫产和顺产均被纳入。 2.妊娠单胎的产妇，初产妇和多胎次妇女均被纳入研究。 3.仰卧屈膝自然放松状态下，脐上2cm、脐下2厘米处，超声下IRD ≥20mm被纳入试验。

Inclusion criteria

1. Women aged 20-45 years, more than one year postpartum, who had undergone either cesarean delivery or vaginal delivery, were included; 2. Participants with singleton pregnancies were enrolled, encompassing both primiparous and multiparous women; 3. An inter-recti distance (IRD) of >=20 mm, measured via ultrasound at 2 cm above and 2 cm below the umbilicus in a supine position with knees flexed and natural relaxation, served as the inclusion criterion.

排除标准：

1.一次妊娠多胎的产妇。 2.IRD≥5cm。 3.过去1年内有规律普拉提或核心训练经验 4.存在运动禁忌症 5.未能填写并提交知情同意书，存在与干预不相容的慢性身体或精神疾病。

Exclusion criteria：

1.Women with a history of multiple gestation; 2.An inter-recti distance (IRD) >=5 cm at baseline assessment; 3.Regular Pilates or core muscle training experience within the past year (defined as consistent training >= once per week for over one month); 4.Presence of any contraindications to exercise; 5.Failure to provide written informed consent, or presence of chronic physical or mental illnesses that are incompatible with the exercise intervention.

研究实施时间：

Study execute time：

从 From 2025-10-10 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-10-10 00:00:00 至 To 2025-10-20 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

20

Group：

Intervention Group

Sample size：

干预措施：

8周普拉提盆腹联合训练，每周两次，每次半个小时

干预措施代码：

Intervention：

An 8-week, twice-weekly combined pelvic and abdominal Pilates training program, with each session lasting 30 minutes.

Intervention code：

组别：

对照组

样本量：

20

Group：

Control Group

Sample size：

干预措施：

基于中国居民膳食指南、中国人群身体活动指南给予饮食、运动指导手册。并进行一小时左右的运动及饮食指导的宣讲，对照组不进行额外的运动训练安排，受试者每周报告本周的运动情况。在8周的实验干预结束后，给予受试者普拉提训练干预。

干预措施代码：

Intervention：

The control group was provided with dietary and exercise guidance manuals based on the Chinese Dietary Guidelines and the Physical Activity Guidelines for Chinese Population. A one-hour educational session on exercise and nutrition was conducted. No additional exercise training regimen was arranged for this group; however, participants were required to report their weekly physical activity. Upon completion of the 8-week experimental intervention period, the control group participants were offered the Pilates training intervention.

Intervention code：

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)：

 北京 

Country：

China 

Province：

Beijing 

City：

Beijing 

单位(医院)：

北京体育大学 

单位级别：

大学 

Institution
hospital：

Beijing Sport University

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

超声下腹直肌间距

指标类型：

主要指标

Outcome：

Inter-recti distance (IRD) measured via ultrasound

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

超声下腹直肌厚度

指标类型：

次要指标

Outcome：

Rectus Abdominis Muscle Thickness Measured via Ultrasound

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

盆腔功能障碍量表

指标类型：

次要指标

Outcome：

Pelvic Floor Distress Inventory-20

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

修正身体自我形象量表

指标类型：

次要指标

Outcome：

The Modified Body Self-Image Scale

Type：

Secondary indicator

测量时间点：

测量方法：

填写量表

Measure time point of outcome：

Measure method：

指标中文名：

Oswestry功能障碍指数

指标类型：

次要指标

Outcome：

Oswestry Disability Index, ODI

Type：

Secondary indicator

测量时间点：

测量方法：

填写量表

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：

无

Sample Name：

None

Tissue：

None

人体标本去向

 其它  

说明

无

Fate of sample：

0thers  

Note：

None

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 20 岁 years
最大 Max age 45 岁 years

性别：

女性

Gender：

Female

随机方法（请说明由何人用什么方法产生随机序列）：

本研究采用完全随机化设计。由不参与受试者招募与干预的人员使用计算机随机数字生成器生成一份完整的随机分配序列。该序列将受试者以1:1的比例随机分配至“普拉提干预组”或“对照组”。为确保分配隐藏，随机分配结果将密封在按顺序编号、不透明的信封中。当一名受试者符合所有纳入标准并签署知情同意书后，研究人员将按顺序开启下一个信封，以执行分组分配。

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

This study employed a complete randomization design. An staff member not involved in participant recruitment or intervention generated a complete random allocation sequence using a computer-based random number generator. This sequence allocated participants at a 1:1 ratio to either the "Pilates Intervention Group" or the "Control Group." To ensure allocation concealment, the group assignments were sealed in sequentially numbered, opaque envelopes. After a participant met all inclusion criteria and provided informed consent, the research staff opened the next sequentially numbered envelope to implement the group assignment.

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：

本实验对实施治疗的治疗师和受试者不设盲，对评估者和数据录入人员设盲，保证参与者对其他人的任务不知情，并鼓励受试者在评估时不要与评估员讨论他们的治疗。

Blinding：

In this trial, the therapists delivering the interventions and the participating subjects were unblinded. However, the outcome assessors and data entry personnel remained blinded to group allocation. Measures were implemented to ensure that personnel were unaware of each other's assignments. Furthermore, participants were strongly encouraged not to discuss their specific treatment details with the assessors during evaluation sessions.

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

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）：

共享时间：首次共享时间在研究主要结果发表后6个月内；数据至少保留3年，期间可持续申请访问。 共享方式：数据使用者需向本研究团队提交正式申请(邮箱azhuzhaoying@163.com)，说明研究目的、数据分析计划及伦理审批证明。经审核通过后，通过安全数据平台：ResMan（http：//www.medresman.org.cn/login.aspx）提供部分或完整数据集。

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

Time of Sharing: The data will become publicly available for the first time within 6 months after the publication of the study's primary results. The data will be retained for at least 3 years, during which period access can be continuously applied for. Method of Sharing: Data users are required to submit a formal application to our research team (via email: azhuzhaoying@163.com), detailing the research purpose, data analysis plan, and proof of ethical approval. Upon successful review, a partial or complete dataset will be provided through the secure data platform: ResMan .

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：

采用标准化电子表格记录受试者基线信息、训练参数、评估指标及不良事件，确保数据完整、准确。源数据管理：纸质文件(如签署的知情同意书、原始记录表)分类存档于上锁文件柜，保存至研究结束后12个月；电子数据加密存储，每日备份至独立服务器，设置分级访问权限。

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

A standardized electronic form was utilized to record participant baseline information, training parameters, assessment metrics, and adverse events, ensuring data integrity and accuracy. Source Data Management: Paper documents (e.g., signed informed consent forms, original case report forms) were categorized and archived in locked filing cabinets, retained for 12 months after study completion. Electronic data were stored with encryption, backed up daily to an independent server, with tiered access permissions implemented.

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：

  2025-10-09 11:15:46