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：	ChiCTR2500100046
最近更新日期： Date of Last Refreshed on：	2025-04-02 09:39:47
注册时间： Date of Registration：	2025-04-02 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	盆底肌联合肺功能训练对老年髋部骨折术后患者肺功能的影响
Public title：	Effect of pelvic floor muscle combined with lung function training on lung function in elderly patients after hip fracture surgery
注册题目简写：
English Acronym：
研究课题的正式科学名称：	盆底肌联合肺功能训练对老年髋部骨折术后患者肺功能的影响
Scientific title：	Effect of pelvic floor muscle combined with lung function training on lung function in elderly patients after hip fracture surgery
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：	田春艳	研究负责人：	田春艳
Applicant：	Chunyan Tian	Study leader：	Chunyan Tian
申请注册联系人电话： Applicant telephone：	+86 186 1820 0032	研究负责人电话： Study leader's telephone：	+86 152 1087 8101
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：	tcy1508@163.com	研究负责人电子邮件： Study leader's E-mail：	1972wuliang@sina.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：	北京市昌平区小汤山镇温泉街390号	研究负责人通讯地址：	北京市昌平区小汤山镇温泉街390号
Applicant address：	390 Wenquan Street, Xiaotangshan, Changping District, Beijing, China	Study leader's address：	390 Wenquan Street, Xiaotangshan, Changping 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：	北京小汤山医院
Applicant's institution：	Beijing Xiaotangshan Hospital
研究负责人所在单位：	北京小汤山医院
Affiliation of the Leader：	Beijing Xiaotangshan 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：	[2023]伦审第(13)号	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：	北京小汤山医院伦理审查委员会
Name of the ethic committee：	Beijing Xiaotangshan Hospital Ethics Review Committee
伦理委员会批准日期： Date of approved by ethic committee：	2023-03-15 00:00:00
伦理委员会联系人：	李佳航
Contact Name of the ethic committee：	Jiahang Li
伦理委员会联系地址：	北京市昌平区小汤山镇银街北路390号
Contact Address of the ethic committee：	390 Wenquan Street, Xiaotangshan, Changping District, Beijing, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 10 6178 9598	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：

北京小汤山医院

Primary sponsor：

Beijing Xiaotangshan Hospital

研究实施负责（组长）单位地址：

北京市昌平区小汤山镇温泉街390号

Primary sponsor's address：

390 Wenquan Street, Xiaotangshan, Changping 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)：
Country：	China	Province：	Beijing	City：
单位(医院)：	北京小汤山医院	具体地址：	北京市昌平区小汤山镇温泉街390号
Institution hospital：	Beijing Xiaotangshan Hospital	Address：	390 Wenquan Street, Xiaotangshan, Changping District, Beijing, China

经费或物资来源：

无

Source(s) of funding：

none

研究疾病：

肺康复

Target disease：

Pulmonary rehabilitation

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：

目前我国逐步进入老龄化社会，老年人由于骨质疏松以及各项基能减退等原因，极易发生跌倒造成骨折，其中髋部骨折最为常见，且多以手术为主，术后感染等并发症多，降低生活质量。本研究为观察盆底肌联合肺功能训练对老年髋部骨折术后患者肺功能的疗效,通过对于老年髋部骨折术后患者进行盆底康复训练，进而改善腹压,纠正呼吸模式,促进排痰,进而改善肺功能,提高康复训练耐力，促进术后康复，提高生活质量。

Objectives of Study：

At present, China is gradually entering an aging society. The elderly are prone to fractures caused by falls due to osteoporosis and the decline of various basic energy, among which hip fracture is the most common, and most of them are surgical, and postoperative infection and other complications reduce the quality of life. The purpose of this study is to observe the effect of pelvic floor muscle combined with lung function training on the lung function of elderly patients after hip fracture surgery. Pelvic floor rehabilitation training for elderly patients after hip fracture surgery can improve abdominal pressure, correct breathing patterns, promote sputum discharge, improve lung function, improve rehabilitation training endurance, promote postoperative rehabilitation and improve quality of life.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

排除标准：

1.合并四肢感染、肿瘤等疾病患者。 2.合并严重内科疾病或其他脏器类损伤患者。 3.合并严重认知障碍、沟通障碍患者。 4.不同意参加本次研究患者。

Exclusion criteria：

1.Patients with diseases such as limbs infection and tumor; 2.Patients with serious internal diseases or other organ injuries; 3.Patients with severe cognitive impairment and communication disorder; 4.Patients who do not agree to participate in this study;

研究实施时间：

Study execute time：

从 From 2023-11-23 00:00:00至 To 2024-11-15 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2023-11-23 00:00:00 至 To 2024-10-12 00:00:00

干预措施：

Interventions：

组别：	联合训练组	样本量：	25
Group：	Joint training unit	Sample size：	25
干预措施：	患者实施常规康复干预外，进行联合训练。嘱患者排尿后、饭后大于1h进行训练，仰卧位，双腿略分开，放松双下肢、臀部及腹部肌肉，告知患者及家属PFMT联合肺功能训练的目的、注意事项及方法，并予教学，训练后进行整理放松运动。 ①盆底肌联合膈肌呼吸训练：患者取仰卧位，鼻吸气时收缩臀部肌肉，收紧肛门或阴道及肛周括约肌，感觉肛门或阴道向上提，保持5~10s；口呼气时慢慢放松肛门10s，吸气后康复医师单手置于上腹部并向内施力，向外呼气时尽量保持胸廓最小活动，每次10min。②盆底肌联合缩唇呼吸训练：缩唇状态紧闭嘴唇经鼻吸气时收缩臀部肌肉，收紧肛门或阴道及肛周括约肌，感觉肛门或阴道向上提，保持3s，后嘴唇呈吹口哨样慢慢呼出同时慢慢放松肛门，保持5s，每次10min。③盆底肌联合胸腔训练：患者取坐位，吸气时缓慢向左转腰，同时收缩臀部肌肉，收紧肛门或阴道及肛周括约肌，感觉肛门或阴道向上提，呼气时放松肛门，缓慢恢复原状，吸气时缓慢向右转腰，同时收缩臀部肌肉，收紧肛门或阴道及肛周括约肌，感觉肛门或阴道向上提，呼气时放松肛门，缓慢恢复原状。左右各1次为1组，每次10组。训练强度适宜，循序渐进，治疗师可单手置于盆底部引导患者进行盆底肌训练，康复训练每日2次，每周5天，共4周。	干预措施代码：
Intervention：	In addition to routine rehabilitation intervention, the patients underwent joint training. After urination and after meals, the patient was instructed to carry out training for more than 1 hour, lying on his back, legs slightly apart, and relax the lower limbs, buttocks and abdominal muscles. The purpose, precautions and methods of PFMT combined lung function training were informed to the patient and his family members, and the training was also taught. (1) Pelvic floor muscle combined with diaphragm breathing training: the patient takes the supine position, contracts the buttock muscles during nasal inhalation, tightens the anus or vagina and perianal sphincter, and feels the anus or vagina lift upward, maintaining for 5~10s; When exhaling through the mouth, slowly relax the anus for 10s. After inhaling, the rehabilitation physician placed one hand on the upper abdomen and exerted inward force. When exhaling out, keep the minimum movement of the chest as far as possible for 10min each time. ② Pelvic floor muscle combined with lip contraction breathing training: When the lips are closed through the nose, contract the buttock muscles, tighten the anus or vagina and perianal sphincter, feel the anus or vagina lift upward for 3s, exhale slowly with the back lip whistling and slowly relax the anus for 5s, 10min each time. ③ Pelvic floor muscle combined chest training: The patient takes the sitting position, slowly turns to the left when inhaling, while contracting the hip muscles, tightening the anus or vagina and perianal sphincter, feeling the anus or vagina lift up, releasing the anus when exhaling, slowly returning to the original position, slowly turning the waist to the right when inhaling, contracting the hip muscles, tightening the anus or vagina and perianal sphincter, feeling the anus or vagina lift up, feeling the anus or vagina relax when exhaling, feeling the anus or vagina lift up, relaxing the anus when exhaling. Slow restoration. 1 group with 10 groups each time. The training intensity is appropriate and gradual. The therapist can place one hand on the pelvic floor to guide the patient to carry out pelvic floor muscle training. The rehabilitation training is conducted twice a day, 5 days a week, for a total of 4 weeks.	Intervention code：

组别：	肺功能训练组	样本量：	25
Group：	Lung function training group	Sample size：	25
干预措施：	患者实施常规康复干预外，进行肺功能训练。嘱患者排尿后、饭后大于1h进行训练，仰卧位，双腿略分开，放松双下肢、臀部及腹部肌肉，告知患者及家属肺功能训练的目的、注意事项及方法，并予教学，训练后进行整理放松运动。 ①膈肌呼吸训练：患者取仰卧位，鼻吸气、口呼气，吸气后康复医师单手置于上腹部并向内施力，向外呼气时尽量保持胸廓最小活动，每次10min。②缩唇呼吸训练：缩唇状态紧闭嘴唇经鼻吸气3s，后嘴唇呈吹口哨样慢慢呼出5s，每次10min。③胸腔训练：患者取坐位，吸气时缓慢向左转腰，呼气时缓慢恢复原状，吸气时缓慢向右转腰，呼气时缓慢恢复原状，左右各1次为1组，每次10组。康复训练每日2次，每周5天，共4周。	干预措施代码：
Intervention：	In addition to routine rehabilitation intervention, the patient underwent lung function training. After urination and after meals, the patient was instructed to carry out training for more than 1 hour, lying on his back, legs slightly apart, and relax the lower limbs, buttocks and abdominal muscles. The purpose, precautions and methods of lung function training were informed to the patient and his family members, and the training was taught. ① Diaphragm breathing training: The patient was placed in a supine position, with nasal inhalation and oral exhalation. After inhalation, the rehabilitation physician placed one hand on the upper abdomen and exerted inward force. During exhalation, the thoracic movement was kept at a minimum for 10min each time. ② Lips contraction breathing training: lips contraction state tight lips through the nose inhale for 3s, back lips whistling slowly exhaled for 5s, 10min each time. (3) Chest training: the patient took the sitting position, slowly turned to the left when inhaling, slowly restored to the original state when exhaling, slowly turned to the right when inhaling, slowly restored to the original state when exhaling, 1 group of 10 groups each time. Rehabilitation training was conducted twice a day, 5 days a week for 4 weeks.	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)：
Country：	China	Province：	Beijing	City：
单位(医院)：	北京小汤山医院	单位级别：	三级
Institution hospital：	Beijing Xiaotangshan Hospital	Level of the institution：	Tertiary

测量指标：

Outcomes：

指标中文名：	用力肺活量	指标类型：	主要指标
Outcome：	Forced vital capacity	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	第一秒用力呼气容积	指标类型：	主要指标
Outcome：	Forced expiratory volume in first second	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	呼气流量峰值	指标类型：	主要指标
Outcome：	Peak expiratory flow	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	自我效能感量表	指标类型：	次要指标
Outcome：	General 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：	盆底肌肌力	指标类型：	次要指标
Outcome：	Pelvic floor muscle strength	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	生活质量调查量表	指标类型：	次要指标
Outcome：	Medical Outcomes Study 36 - Item Short - Form Health Survey	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	腹压	指标类型：	次要指标
Outcome：	intra-abdominal pressure	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：

结束

/Completed

年龄范围：

Participant age：

最小 Min age	60	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）：

随机数字表

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

Random number table

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）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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）：	2026/1/1 中国国家生物医学大数据中心https://www.cncb.ac.cn/
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	2026/1/1China National Biomedical Big Data Center,https://www.cncb.ac.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：	数据管理采用纸质+电子管理流程，制定电子版CRF表，每位受试者一份，并打印出来，存放于指定位置此表主要内容包括受试者基本信息、临床相关资料、知情同意书、随访记录、副作用量表等。测试的相关数据则录入指定电脑，采用电子化管理流程，进行严格的数据管理与质量控制。当患者剔除、脱落后，研究者应尽可能与患者联系，完成所能完成的评估项目，并填写试验结束表，详细记录试验治疗记录。对因不良反应而脱落者，经随访最后判断与试验有关者，必须记录在CRF表并通知申办者。对任何脱落病例，研究者必须在CRF表中填写脱落的原因，一般情况下有6种：即不良事件、缺乏疗效、违背试验方案（包括依从性差者）、失访（包括患者自行退出）、被申办者中止和其他。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Each subject had one copy of the electronic CRF form, which was printed out and stored in the designated place. The main contents of the form included the basic information of the subjects, clinical related data, informed consent, follow-up records, side effects scale, etc. The relevant data of the test is entered into the designated computer, and the electronic management process is adopted to carry out strict data management and quality control. When a patient was excluded or dropped out, the investigator should contact the patient as much as possible to complete the evaluation items that could be completed, fill in the end of the trial form, and record the trial treatment record in detail. Dropouts due to adverse events should be recorded on the CRF form and notified to the sponsor. For any dropouts, investigators were required to fill in the CRF form the reasons for dropouts, which generally included six reasons: adverse events, lack of efficacy, protocol violations (including nonadherence), loss to follow-up (including withdrawal by the patient), discontinuation by the sponsor, and others.
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2025-04-02 09:39:11