ChiCTR2400086860 版本V1.0 版本创建时间2024/07/12 15:14:28 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：

ChiCTR2400086860 

最近更新日期：

Date of Last Refreshed on：

2024-07-12 15:14:24 

注册时间：

Date of Registration：

2024-07-12 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

吸气肌训练对肺移植患者肺功能、膈肌功能和运动能力的影响

Public title：

Effects of inspiratory muscle training on lung function, diaphragm function and exercise capacity in lung transplant recipients

注册题目简写：

English Acronym：

研究课题的正式科学名称：

吸气肌训练对肺移植患者肺功能、膈肌功能和运动能力的影响

Scientific title：

Effects of inspiratory muscle training on lung function, diaphragm function and exercise capacity in lung transplant recipients

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：

冯梦月 

研究负责人：

冯梦月 

Applicant：

Mengyue Feng 

Study leader：

Mengyue Feng 

申请注册联系人电话：

Applicant telephone：

+86 158 5280 5056

研究负责人电话：

Study leader's telephone：

+86 158 5280 5056

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：

1641094049@qq.com

研究负责人电子邮件：

Study leader's E-mail：

1641094049@qq.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：

江苏省无锡市梁溪区清扬路299号无锡市人民医院

研究负责人通讯地址：

江苏省无锡市梁溪区清扬路299号无锡市人民医院

Applicant address：

Wuxi People's Hospital, No. 299, Qingyang Road, Liangxi District, Wuxi City, Jiangsu Province, China

Study leader's address：

Wuxi People's Hospital, No. 299, Qingyang Road, Liangxi District, Wuxi City, Jiangsu Province, 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：

无锡市人民医院

Applicant's institution：

The Affiliated Wuxi People's Hospital of Nanjing Medical University, Wuxi People's Hospital, Wuxi Medical Center, Nanjing Medical University

研究负责人所在单位：

无锡市人民医院

Affiliation of the Leader：

The Affiliated Wuxi People's Hospital of Nanjing Medical University, Wuxi People's Hospital, Wuxi Medical Center, Nanjing Medical 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：

(2024)科研伦审(KY24095)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：

无锡市人民医院科研伦理委员会

Name of the ethic committee：

Research Ethics Committee of Wuxi People's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2024-06-19 00:00:00

伦理委员会联系人：

陆培华

Contact Name of the ethic committee：

Lu Peihua

伦理委员会联系地址：

江苏省无锡市清扬路299号无锡市人民医院

Contact Address of the ethic committee：

Wuxi People's Hospital, No. 299 Qingyang Road, Wuxi City, Jiangsu Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 510 8535 0835

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：

无锡市人民医院

Primary sponsor：

The Affiliated Wuxi People's Hospital of Nanjing Medical University, Wuxi Medical Center

研究实施负责（组长）单位地址：

江苏省无锡市梁溪区清扬路299号无锡市人民医院

Primary sponsor's address：

Wuxi People's Hospital, No. 299, Qingyang Road, Liangxi District, Wuxi City, Jiangsu Province, 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)：

无锡

Country：

China

Province：

Jiangsu

City：

Wuxi

单位(医院)：

无锡市人民医院

具体地址：

江苏省无锡市梁溪区清扬路299号无锡市人民医院

Institution
hospital：

The Affiliated Wuxi People's Hospital of Nanjing Medical University, Wuxi Medical Center

Address：

Wuxi People's Hospital, No. 299, Qingyang Road, Liangxi District, Wuxi City, Jiangsu Province, China

经费或物资来源：

无

Source(s) of funding：

no

Target disease：

lung transplantation

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：

探讨吸气肌训练对肺移植患者肺功能、膈肌功能和运动能力的影响。  

Objectives of Study：

To investigate the effects of inspiratory muscle training on pulmonary function, diaphragm function and exercise capacity in lung transplant patients.

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患者成功完成肺移植手术，一周内撤除体外膜肺氧合（extracorporeal membrane oxygenation，ECMO）和呼吸机； ②年龄大于18岁； ③生命体征平稳-收缩压90-180mmHg，平均动脉压：65-110mmHg ；心率：40-120次／分；没有新发的心律失常和心肌缺血；没有伴随血乳酸，＞4mmolFL的休克征象；没有新发的不稳定性深静脉血栓和肺动脉栓塞；没有可疑的主动脉狭窄；吸入氧浓度（FiO2）：≤0.6;血氧饱和度（SpO2）：＞90%;呼吸频率：≤40次／分;没有严重的肝肾基础疾病或新发的进行性加重的肝肾功能损害；没有活动性出血；体温≤38.5℃； RASS评分0分，可配合康复训练； ④认知功能正常，CAM- ICU阴性。 ⑤患者或家属愿意签署知情同意书并参与该研究者。

Inclusion criteria

① Patients successfully completed lung transplantation, and extracorporeal membrane lung oxygenation (ECMO) and ventilator were withdrawn within one week; ② Age greater than 18 years old; ③ Vital signs are stable - systolic blood pressure 90-180mmHg, mean arterial pressure: 65-110mmHg; heart rate: 40-120 beats/min; no new cardiac arrhythmia and myocardial ischemia; no signs of shock accompanied by blood lactic acid, >4mmolFL; no new unstable deep vein thrombosis and pulmonary embolism; no suspected aortic stenosis; inhaled oxygen concentration ( FiO2): ≤0.6; blood oxygen saturation (SpO2): >90%; respiratory rate: ≤40 breaths/min; no severe underlying hepatic or renal disease or new-onset progressive exacerbation of hepatic or renal impairment; no active bleeding; body temperature ≤38.5°C; RASS score of 0, and can be cooperated with rehabilitation training; ④ Normal cognitive function and negative CAM- ICU. ⑤ Patients or family members who were willing to sign the informed consent and participate in the study.

排除标准：

①机械通气超过一周的患者； ②严重吻合口并发症； ③无法正确配合治疗者； ④新发肺栓塞、下肢深静脉血栓等并发症； ⑤有严重精神或认知障碍； ⑥接受多器官移植、再次移植的患者； ⑦膈神经完全损伤的患者； ⑧不愿意或无法提供书面知情同意的患者。

Exclusion criteria：

① Patients who have been mechanically ventilated for more than one week; ② Severe anastomotic complications; ③ Those who cannot properly cooperate with the treatment; ④ New pulmonary embolism, lower extremity deep vein thrombosis and other complications; ⑤ Those with severe mental or cognitive disorders; ⑥ Patients who have received multi-organ transplantation and re-transplantation; ⑦ Patients with complete damage to the phrenic nerve; (8) Patients who are unwilling or unable to provide written informed consent.

研究实施时间：

Study execute time：

从 From 2024-07-01 00:00:00至 To 2026-07-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-07-12 00:00:00 至 To 2026-07-01 00:00:00  

干预措施：

Interventions：

组别：

吸气肌训练+标准肺康复组

样本量：

29

Group：

inspiratory muscle training + the standard pulmonary rehabilitation group

Sample size：

干预措施：

使用赛客肺功能检测仪进行吸气肌训练。训练强度从口腔压力测量获得的最大吸气压力值（MIP）的30%开始逐步递增到60%MIP，患者被要求进行30个吸气肌训练，每天两次，每周五天，为期四周。 1腹式呼吸训练:口头教育和指导训练，每组 15 次重复，然后休息 2-3 分钟，共 3 组。 患者用鼻子慢慢吸气至肺活量最大，屏住呼吸 2-3s，然后用腹肌收紧由鼻尖慢慢呼气; 2有效咳嗽训练:要求患者进行缓慢的呼吸以达到最大吸气量，屏气 2-3s，然后突然 向内收缩腹肌，打开声门用力咳嗽。患者或物理治疗师的一只手压在手术区域上以支撑伤口， 防止压力过大引起疼痛并鼓励更大的呼气量。每次 10*3 组，每组间歇 3-5 分钟; 3步行训练:运动强度为最大心率的 50%-70%，以呼吸困难的严重程度和疲劳度为基 础，逐渐增加运动强度，每次 15 分钟。在运动过程中，记录血氧饱和度、心率、BORG 和 呼吸困难评分以及运动距离。出现胸闷或呼吸急促时，要求他们放慢脚步或停止行走。

干预措施代码：

Intervention：

Inspiratory muscle training was performed using a cycler lung function tester. The intensity of the training started from 30% of the maximal inspiratory pressure value (MIP) obtained from oral pressure measurements progressively increasing to 60% MIP, and the patients were asked to perform 30 inspiratory muscle training exercises twice a day, five days a week, for four weeks. 1 Abdominal breathing training:Verbal education and instruction training, 15 repetitions per group, then rest for 2-3 minutes, 3 groups in total. The patient inhales slowly through the nose to the maximum lung capacity, holds the breath for 2-3s, and then exhales slowly through the tip of the nose with the abdominal muscles tightened. 2 Effective Coughing Exercise: The patient is asked to breathe slowly to reach the maximum inspiratory capacity, hold the breath for 2-3s, and then suddenly contract the abdominal muscles inward, open the vocal folds and cough forcefully. The patient or physiotherapist presses one hand over the surgical area to support the wound, preventing pain from excessive pressure and encouraging greater exhalation. 3 sets of 10*3 with a 3-5 minute break between sets. 3 Walking: Exercise at 50%-70% of maximum heart rate for 15 minutes at a time, gradually increasing the intensity based on the severity of dyspnea and fatigue. During exercise, record oxygen saturation, heart rate, BORG and dyspnea scores, and exercise distance. When chest tightness or shortness of breath occurs, ask them to slow down or stop walking.

Intervention code：

组别：

标准肺康复组

样本量：

29

Group：

the standard pulmonary rehabilitation group

Sample size：

干预措施：

1腹式呼吸训练:口头教育和指导训练，每组 15 次重复，然后休息 2-3 分钟，共 3 组。 患者用鼻子慢慢吸气至肺活量最大，屏住呼吸 2-3s，然后用腹肌收紧由鼻尖慢慢呼气; 2有效咳嗽训练:要求患者进行缓慢的呼吸以达到最大吸气量，屏气 2-3s，然后突然 向内收缩腹肌，打开声门用力咳嗽。患者或物理治疗师的一只手压在手术区域上以支撑伤口， 防止压力过大引起疼痛并鼓励更大的呼气量。每次 10*3 组，每组间歇 3-5 分钟; 3步行训练:运动强度为最大心率的 50%-70%，以呼吸困难的严重程度和疲劳度为基 础，逐渐增加运动强度，每次 15 分钟。在运动过程中，记录血氧饱和度、心率、BORG 和 呼吸困难评分以及运动距离。出现胸闷或呼吸急促时，要求他们放慢脚步或停止行走。

干预措施代码：

Intervention：

1 Abdominal breathing training:Verbal education and instruction training, 15 repetitions per group, then rest for 2-3 minutes, 3 groups in total. The patient inhales slowly through the nose to the maximum lung capacity, holds the breath for 2-3s, and then exhales slowly through the tip of the nose with the abdominal muscles tightened. 2 Effective Coughing Exercise: The patient is asked to breathe slowly to reach the maximum inspiratory capacity, hold the breath for 2-3s, and then suddenly contract the abdominal muscles inward, open the vocal folds and cough forcefully. The patient or physiotherapist presses one hand over the surgical area to support the wound, preventing pain from excessive pressure and encouraging greater exhalation. 3 sets of 10*3 with a 3-5 minute break between sets. 3 Walking: Exercise at 50%-70% of maximum heart rate for 15 minutes at a time, gradually increasing the intensity based on the severity of dyspnea and fatigue. During exercise, record oxygen saturation, heart rate, BORG and dyspnea scores, and exercise distance. When chest tightness or shortness of breath occurs, ask them to slow down or stop walking.

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)：

 无锡 

Country：

China 

Province：

Jiangsu 

City：

Wuxi 

单位(医院)：

无锡市人民医院 

单位级别：

三甲 

Institution
hospital：

The Affiliated Wuxi People's Hospital of Nanjing Medical University, Wuxi Medical Center

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

最大吸气压

指标类型：

主要指标

Outcome：

Maximal inspiratory pressure(MIP)

Type：

Primary indicator

测量时间点：

术前、术后脱机拔管生命体征稳定，术后训练后四周，术后三个月、术后半年、术后一年

测量方法：

Measure time point of outcome：

Pre-operative, post-operative extubation vital signs stabilized, four weeks after post-operative training, three months post-operative, six months post-operative, one year post-operative

Measure method：

指标中文名：

最大呼气压

指标类型：

次要指标

Outcome：

Maximum Expiratory Pressure(MEP)

Type：

Secondary indicator

测量时间点：

术前、术后脱机拔管生命体征稳定，术后训练后四周，术后三个月、术后半年、术后一年

测量方法：

Measure time point of outcome：

Pre-operative, post-operative extubation vital signs stabilized, four weeks after post-operative training, three months post-operative, six months post-operative, one year post-operative

Measure method：

指标中文名：

用力肺活量

指标类型：

次要指标

Outcome：

Forced vital capacity(FVC)

Type：

Secondary indicator

测量时间点：

术前、术后脱机拔管生命体征稳定，术后训练后四周，术后三个月、术后半年、术后一年

测量方法：

Measure time point of outcome：

Pre-operative, post-operative extubation vital signs stabilized, four weeks after post-operative training, three months post-operative, six months post-operative, one year post-operative

Measure method：

指标中文名：

第1秒用力呼气容积

指标类型：

次要指标

Outcome：

Forced expiratory volume in one second(FEV1)

Type：

Secondary indicator

测量时间点：

术前、术后脱机拔管生命体征稳定，术后训练后四周，术后三个月、术后半年、术后一年

测量方法：

Measure time point of outcome：

Pre-operative, post-operative extubation vital signs stabilized, four weeks after post-operative training, three months post-operative, six months post-operative, one year post-operative

Measure method：

指标中文名：

膈肌厚度

指标类型：

次要指标

Outcome：

Diaphragm thickness(DT)

Type：

Secondary indicator

测量时间点：

术前、术后脱机拔管生命体征稳定，术后训练后四周，术后三个月、术后半年、术后一年

测量方法：

Measure time point of outcome：

Pre-operative, post-operative extubation vital signs stabilized, four weeks after post-operative training, three months post-operative, six months post-operative, one year post-operative

Measure method：

指标中文名：

膈肌活动度

指标类型：

次要指标

Outcome：

Diaphragm excursion(DE)

Type：

Secondary indicator

测量时间点：

术前、术后脱机拔管生命体征稳定，术后训练后四周，术后三个月、术后半年、术后一年

测量方法：

Measure time point of outcome：

Pre-operative, post-operative extubation vital signs stabilized, four weeks after post-operative training, three months post-operative, six months post-operative, one year post-operative

Measure method：

指标中文名：

六分钟步行距离

指标类型：

次要指标

Outcome：

Six minute walking distance(6MWD)

Type：

Secondary indicator

测量时间点：

术前、术后脱机拔管生命体征稳定，术后三个月、术后半年、术后一年

测量方法：

Measure time point of outcome：

Pre-operative, four weeks after post-operative training, three months post-operative, six months post-operative, one year post-operative

Measure method：

指标中文名：

术后并发症

指标类型：

次要指标

Outcome：

Postoperative complication

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 80 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）：

利用excel生成随机数字表，具体方法如下：本研究预计纳入研究对象58名，因此先在excel中用rand函数随机生成生成58个0-1之间的随机数，再利用rank函数对这58个随机数进行排序从而得到一组1-58随机排列不重复的随机数字表。

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

The use of excel to generate a table of random numbers, the specific method is as follows: this study is expected to be included in the study population of 58, so first in excel using the rand function to generate a random generation of 58 random numbers between 0-1, and then the use of the rank function of the 58 random numbers sorted so as to get a set of 1-58 randomly arranged non-repeating 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：

单盲，只有受试者不知道分组。

Blinding：

Single blind, only the subject does not know their group.

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

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：

数据采集由专人负责，通过观察记录表收集，其中观察记录表名称：吸气肌训练对肺移植患者肺功能、膈肌功能和运动能力的影响观察记录表。由受试者本人填写量表并完成测试，采集完成后及时录入数据库中。

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

The data were collected by special personnel through observation record table. The observation record table was named: Effects of inspiratory muscle training on lung function, diaphragm function and exercise capacity in lung transplant recipients. The questionnaire was filled out by the subjects themselves and the test was completed. After the collection was completed, the questionnaire was entered into the database in time.

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：

  2024-07-12 15:14:24