ChiCTR2500112726 版本V1.0 版本创建时间2025/11/19 08:31:10 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：

 ChiCTR2500112726 

最近更新日期：

Date of Last Refreshed on：

 2025-11-19 08:31:03 

注册时间：

Date of Registration：

 2025-11-19 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

运动疗法联合内脏松弛术对产妇盆底结构超声参数及生活质量的影响

Public title：

The influence of exercise therapy combined with visceral relaxation on the ultrasound parameters of pelvic floor structure and quality of life of parturients

注册题目简写：

English Acronym：

研究课题的正式科学名称：

运动疗法联合内脏松弛术对产妇盆底结构超声参数及生活质量的影响

Scientific title：

The influence of exercise therapy combined with visceral relaxation on the ultrasound parameters of pelvic floor structure and quality of life of parturients

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：

郭艮春 

研究负责人：

郭艮春 

Applicant：

Guo Genchun 

Study leader：

Guo Genchun 

申请注册联系人电话：

Applicant telephone：

 +86 182 0510 6358

研究负责人电话：

Study leader's
telephone：

+86 182 0510 6358

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：

 guogenchun@njmu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

 guogenchun@njmu.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：

中国江苏省盐城市盐都区新都西路2号

研究负责人通讯地址：

中国江苏省盐城市盐都区新都西路2号

Applicant address：

No. 2, Xindu West Road, Yandu District, Yancheng, Jiangsu, China

Study leader's address：

No. 2, Xindu West Road, Yandu District, Yancheng, Jiangsu, 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：

盐城市第三人民医院

Applicant's institution：

Yancheng Third People's Hospital

研究负责人所在单位：

盐城市第三人民医院

Affiliation of the Leader：

Yancheng Third People's Hospital

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：

 伦审-2024-46

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：

盐城市第三人民医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Yancheng Third People's Hospita

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-05-08 00:00:00

伦理委员会联系人：

宋建祥

Contact Name of the ethic committee：

Song Jianxiang

伦理委员会联系地址：

中国江苏省盐城市盐都区新都西路2号

Contact Address of the ethic committee：

No. 2, Xindu West Road, Yandu District, Yancheng, Jiangsu, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 515 8160 8812

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：

盐城市第三人民医院

Primary sponsor：

Yancheng Third People's Hospital

研究实施负责（组长）单位地址：

中国江苏省盐城市盐都区新都西路2号

Primary sponsor's address：

No. 2, Xindu West Road, Yandu District, Yancheng, Jiangsu, 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)：

江苏

市(区县)：

Country：

China

Province：

Jiangsu

City：

单位(医院)：

盐城市第三人民医院

具体地址：

中国江苏省盐城市盐都区新都西路2号

Institution
hospital：

Yancheng Third People's Hospital

Address：

No. 2, Xindu West Road, Yandu District, Yancheng, Jiangsu, China

经费或物资来源：

盐城市卫生健康委员会

Source(s) of funding：

Yancheng Municipal Health Commission

研究疾病：

产后盆底功能障碍  

Target disease：

Postpartum pelvic floor dysfunction

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：

1，探索内脏松弛术对产妇盆底结构功能恢复、生活质量改善方面等影响。 2，完善产妇分娩后功能恢复的康复路径，建立产后功能恢复的康复方案库，培养产妇良好的遵医行为。 3，提高产妇自我管理能力和依从性提高产妇的自我效能，倡导医学重心从疾病向健康转变、从治疗向预防及康复转变，在做好产后功能恢复的同时，构建具预防、康复新模式，为广大产妇提供全方位、全周期的健康服务。 4，普及产妇分娩康复训练的技能和知识，改善产妇自我管理能力，提升产妇健康认知及社会关注度。  

Objectives of Study：

Explore the impact of visceral relaxation surgery on the recovery of pelvic floor structure and function and the improvement of quality of life in parturients. 2. Improve the rehabilitation path for postpartum functional recovery of parturients, establish a rehabilitation program library for postpartum functional recovery, and cultivate good compliance with medical advice among parturients. 3. Enhance the self-management ability and compliance of postpartum women. Improve the self-efficacy of postpartum women, advocate the shift of medical focus from disease to health, and from treatment to prevention and rehabilitation. While doing a good job in postpartum functional recovery, build a new model of prevention and rehabilitation to provide comprehensive and full-cycle health services for a large number of postpartum women. 4. Popularize the skills and knowledge of postpartum rehabilitation training for parturients, improve their self-management abilities, and enhance their health awareness and social attention.

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）产后6周至12周； （2）无临床证实的系统性疾病史，如神经系统疾病和心功能不全，目前未佩戴心脏起搏器或接受激素治疗，和/或未在孕前接受骨盆和吊带根治性手术或脱垂手术，无妊娠并发症； （3）愿意参加并签署知情同意书； （4）能够阅读，没有因教育程度低或被诊断为精神问题而产生的认知问题。

Inclusion criteria

(1) From 6 to 12 weeks postpartum; (2) No clinically confirmed history of systemic diseases, such as neurological diseases and heart failure, currently not wearing a pacemaker or receiving hormone therapy, and/or not having undergone radical pelvic and sling surgery or prolapse surgery before pregnancy, and no pregnancy complications; (3) Be willing to participate and sign the informed consent form; (4) Be capable of reading without cognitive problems resulting from low educational attainment or diagnosis of mental disorders.

排除标准：

(1)经产后盆腔检查，经改良牛津量表(MOS)确认盆底肌力> 3级者将被排除； (2)盆腔器官脱垂定量(POP-Q)≥III期； (3)经症状证实为严重尿失禁(每天尿失禁发作一次以上，且安静状态下发生大量尿丢失或尿漏，归为严重尿失禁); (4)任何肢体功能障碍，使妇女无法接受这种训练。如果参与者在随访期间怀孕，将被记录为“退出试验”。

Exclusion criteria：

(1) After postpartum pelvic examination, those with pelvic floor muscle strength greater than grade 3 confirmed by the Modified Oxford Scale (MOS) will be excluded. (2) Quantitative pelvic organ prolapse (POP-Q)>= stage III; (3) Severe urinary incontinence is confirmed by symptoms (urinary incontinence occurs more than once a day, and a large amount of urine loss or leakage occurs in a resting state, which is classified as severe urinary incontinence); (4) Any physical dysfunction that makes it impossible for women to receive such training. If a participant becomes pregnant during the follow-up period, it will be recorded as "withdrawal from the trial".

研究实施时间：

Study execute time：

从 From 2025-12-01 00:00:00至 To 2026-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-12-01 00:00:00 至 To 2026-12-31 00:00:00

干预措施：

Interventions：

组别：

对照组

样本量：

 23

Group：

Control group

Sample size：

干预措施：

参与者将参加由一位经验丰富的康复治疗师指导的为期12周的运动疗法计划。在12周的干预期间分为3个阶段完成。每个阶段设计3~5组项目，锻炼计划根据患者的身体恢复适时调整，主要包括盆底肌功能锻炼，腰骨盆脊柱周围肌群核心稳定训练及呼吸训练等。处方参数在内的运动疗法的详细信息见附录。1~4周：腹式呼吸，卷腹运动，桥式运动，腹横肌激活，盆底肌激活，仰卧抬腿。5-8周：左右卷腹，跪姿收腹，跪姿伸腿，靠墙静蹲（屈膝150°），桥式运动进阶，蚌式开合。9-12周：平板支撑，侧平板支撑，死虫运动，靠墙下蹲（屈膝120°），侧支撑顶髋，侧卧抬腿。

干预措施代码：

Intervention：

Participants will take part in a 12-week exercise therapy program guided by an experienced rehabilitation therapist The 12-week intervention period was completed in three stages. For each stage, 3 to 5 sets of exercises are designed. The exercise plan is adjusted in a timely manner according to the patient's physical recovery, mainly including pelvic floor muscle function exercises, core stability training for the lumbar, pelvic and spinal peripheral muscle groups, and breathing training, etc. Detailed information on exercise therapy, including prescription parameters, is provided in the appendix. Weeks 1 to 4: Abdominal breathing, crunches, bridge exercises, activation of the transverse abdominis muscles, activation of the pelvic floor muscles, and leg raises while lying on the back. Weeks 5-8: Left and right crunches, kneel to draw in the abdomen, kneel to stretch the legs, squat against the wall (with knees bent at 150°), advanced bridge exercises, oyster opening and closing. Weeks 9-12: Plank, side plank, deadworm exercise, wall squat (bend knees 120°), side plank hip support, leg lift while lying on the side.

Intervention code：

组别：

试验组

样本量：

 23

Group：

Experimental Group

Sample size：

干预措施：

在对照组的基础上增加内脏松弛术手法治疗。主要作用于腹部和盆腔内脏筋膜，在腹部不同区域通过缓慢和深度移动进行内脏松弛，同时考虑受试者的组织阻力和疼痛反应。每个动作最多执行2分钟。具体如下：患者均取仰卧位，头下垫枕头牵拉膝盖，以减轻其他手法应用时对腹壁的张力。对于幽门，医生站在患者左侧，食指和中指跟随幽门上方深部结构和筋膜的松动，慢慢地向后进入，进行小的圆形活动，直到触诊0.5 ~ 1 cm的幽门。对于Oddi括约肌，医生站在患者右侧，食指和中指在Oddi括约肌上方做小圆周活动，随着深部结构和筋膜的放松慢慢进入颅后。对于DJF，医生站在患者的左侧，用食指和中指进行小的圆形活动，随着肠道逐渐打开和筋膜松动并向后进入，直到触诊到DJF上方0.5至1厘米的压敏点。对于回盲瓣，医生站在患者的右侧，用食指和中指在回盲瓣上向后进入，慢慢地跟随深部结构和筋膜的松动，直到摸到一个坚实的，0.5至1厘米，大约榛子大小的压力敏感点。对于乙状结肠，医生站在患者右侧，乙状结肠从左侧髂骨内侧缓慢下降至双手，从乙状结肠外侧缓慢移动至肚脐。对于肝脏，医生站在病人的左侧，用病人的腿在额平面调动肝脏。对于小肠，患者左侧卧位，双腿弯曲。站在患者身后，双手指向后，从降结肠内侧和小肠外侧入腹。小肠向患者右肩移动。对于肾脏，站在对面的肾脏要被动员起来。在患者呼气时，右肾从患者回盲瓣大致水平沿升结肠内侧向颅内侧移动。当患者呼气时，左肾从患者乙状结肠的大致水平沿降结肠的内侧边缘向脑内侧移动。对于横膈膜，医生站在患者一侧，双手从下方抓住肋骨施加压力，并间接在胸部上方活动，交替向左和向右移动。

干预措施代码：

Intervention：

On the basis of the control group, manual treatment of visceral relaxation was added. It mainly acts on the visceral fascia in the abdomen and pelvic cavity, relaxing the viscera through slow and deep movement in different areas of the abdomen, while taking into account the tissue resistance and pain response of the subjects. Each action can be performed for a maximum of 2 minutes. All patients were placed in a supine position, with pillows placed under their heads to pull their knees, in order to reduce the tension on the abdominal wall when other techniques were applied. For the pylorus, the doctor stands on the patient's left side, with the index and middle fingers following the loosening of the deep structure and fascia above the pylorus, slowly entering backward and performing small circular movements until the pylorus is palpated at a depth of 0.5 to 1 cm. For the Oddi sphincter, the doctor stands on the patient's right side, with the index and middle fingers making small circular movements above the Oddi sphincter. As the deep structures and fascia relax, they gradually enter the back of the skull. For DJF, the doctor stands on the left side of the patient and makes small circular movements with the index and middle fingers. As the intestines gradually open and the fascia loosens, the doctor enters backward until a pressure-sensitive point 0.5 to 1 centimeter above DJF is palpated. For the ileocecal valve, the doctor stands on the right side of the patient, uses the index and middle fingers to enter backward on the ileocecal valve, and slowly follows the loosening of the deep structure and fascia until a firm, 0.5 to 1 centimeter, approximately the size of a hazelnut pressure-sensitive point is felt. For the sigmoid colon, the doctor stands on the patient's right side. The sigmoid colon slowly descends from the inner side of the left ilium to both hands and then slowly moves from the outer side of the sigmoid colon to the navel. For the liver, the doctor stands on the patient's left side and uses the patient's leg to move the liver at the frontal level. For the small intestine, the patient lies on the left side with the legs bent. Stand behind the patient, point your hands backward, and enter the abdomen from the inner side of the descending colon and the outer side of the small intestine. The small intestine moved towards the patient's right shoulder. For the kidneys, the kidney standing opposite needs to be mobilized. When the patient exhales, the right kidney moves approximately horizontally from the ileocecal valve along the inner side of the ascending colon to the intracranial side. When the patient exhales, the left kidney moves roughly horizontally from the sigmoid colon along the inner edge of the descending colon towards the inner side of the brain. For the diaphragm, the doctor stands on the patient's side, grabs the ribs from below with both hands to apply pressure, and moves indirectly above the chest, alternately moving left and right.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 江苏 

市(区县)：

  

Country：

China

Province：

Jiangsu

City：

单位(医院)：

 盐城市第三人民医院 

单位级别：

 三甲 

Institution
hospital：

Yancheng Third People's Hospita

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

盆底超声检查

指标类型：

主要指标

Outcome：

Pelvic floor ultrasound 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：

盆底功能障碍量表

指标类型：

次要指标

Outcome：

Pelvic floor dis-tress inventory-short form 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：

盆底肌肉锻炼自我效能量表

指标类型：

次要指标

Outcome：

Broome pelvic muscle self-efficacy scale

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

健康状况调查简表 ( SF－36)

指标类型：

次要指标

Outcome：

Health Status Survey Brief Form (SF-36)

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：

无

组织：

Sample Name：

None

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 岁 years
最大 Max age 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）：

随机数字表法

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

Random number table method

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

否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：

数据采集以病例记录表的模式，数据汇总后将纳入ResMan

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

Data was collected in the form of a case record form, and the data will be aggregated into ResMan

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-11-19 08:31:03