ChiCTR2500104698 版本V1.0 版本创建时间2025/06/20 17:30:38 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：

ChiCTR2500104698 

最近更新日期：

Date of Last Refreshed on：

2025-06-20 17:30:26 

注册时间：

Date of Registration：

2025-06-20 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

呼吸肌抗阻训练在脑卒中后吞咽障碍患者中的应用研究

Public title：

A Study on the Application of Respiratory Muscle Resistance Training in Post-Stroke Patients with Dysphagia

注册题目简写：

English Acronym：

研究课题的正式科学名称：

呼吸肌抗阻训练在脑卒中后吞咽障碍患者中的应用研究

Scientific title：

A Study on the Application of Respiratory Muscle Resistance Training in Post-Stroke Patients with Dysphagia

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：

钟兴明 

研究负责人：

董利英 

Applicant：

Xingming Zhong 

Study leader：

Liying Dong 

申请注册联系人电话：

Applicant telephone：

+86 138 6728 6288

研究负责人电话：

Study leader's telephone：

+86 138 6728 6288

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：

zhongxingming@126.com

研究负责人电子邮件：

Study leader's E-mail：

zhongxingming@126.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：

浙江省湖州市广场后路158号

研究负责人通讯地址：

浙江省湖州市广场后路158号

Applicant address：

158 Square Back Road, Huzhou, Zhejiang

Study leader's address：

158 Square Back Road, Huzhou, Zhejiang

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：

湖州市第一人民医院

Applicant's institution：

The First People’s Hospital of Huzhou, Zhejiang, China

研究负责人所在单位：

湖州市第一人民医院

Affiliation of the Leader：

The First People’s Hospital of Huzhou, Zhejiang, China

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：

伦审(2023KYL052)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：

湖州市第一人民医院医学科研与临床试验伦理委员会

Name of the ethic committee：

The First People’s Hospital of Huzhou,Medical Research and clinical trial Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2023-06-20 00:00:00

伦理委员会联系人：

严冰

Contact Name of the ethic committee：

bing yan

伦理委员会联系地址：

浙江省湖州市广场后路158号

Contact Address of the ethic committee：

158 Square Back Road, Huzhou, Zhejiang

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 138 5727 7611

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：

浙江省湖州市第一人民医院

Primary sponsor：

Huzhou First People's Hospital

研究实施负责（组长）单位地址：

浙江省湖州市广场后路158号

Primary sponsor's address：

158 Square Back Road, Huzhou, Zhejiang

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

浙江

市(区县)：

Country：

China

Province：

ZheJiang

City：

单位(医院)：

湖州市第一人民医院

具体地址：

浙江省湖州市广场后路158号

Institution
hospital：

Huzhou First People's Hospital

Address：

158 Square Back Road, Huzhou, Zhejiang

经费或物资来源：

资助经费: 由省级医药卫生部门提供的一般项目资助,金额为人民币3万元。 单位配套资金: 根据项目要求,本单位将提供与资助经费等额的配套资金,金额同样为人民币3万元。 总资金: 合计人民币6万元。

Source(s) of funding：

Funding: This project is supported by a general project grant from the provincial medical and health department, with an amount of RMB 30,000. Matching Funds from the Institution: In accordance with the project requirements, our institution will provide matching funds equivalent to the grant amount, which is also RMB 30,000. Total Funding: The combined funding totals RMB 60,000.

Target disease：

Dysphagia after stroke

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

通过呼吸肌抗阻训练改善患者吞咽、肺功能,以期降低吸入性肺炎发生率,加速患者康复,有助于提高患者依从性,从而提高患者的运动耐力、日常生活活动能力,改善患者的预后。  

Objectives of Study：

Improving patients' swallowing and pulmonary functions through respiratory muscle resistance training is expected to reduce the incidence ofaspiration pneumonia and accelerate patient recovery. This approach also helps enhance patient compliance, thereby increasing patients' exercise tolerance and activities of daily living (ADL) capabilities, and ultimately improving their prognosis.

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)符合 2014 年中国急性脑卒中诊治指南诊断标准，并经头部 CT 或MRI 检查证实； (2)洼田饮水试验测试在 3 级及以上，并经吞咽造影检查确认存在吞咽功能障碍； (3)年龄 18-65 岁； (4)患者首次发病，病情稳定后 48 小时； (5)无认知功能障碍，例如：失语症、听理解障碍、注意力障碍和感知觉障碍等； (6)无意识障碍，清醒且能配合的患者； (7)获得患者及家属同意，并签署知情同意书；

Inclusion criteria

1. Meet the diagnostic criteria of the 2014 Chinese Guidelines for the Diagnosis and Treatment of Acute Stroke, confirmed by cranial CT or MRI. 2.A score of Grade 3 or above on the Water Swallowing Test, with swallowing dysfunction demonstrated by videofluoroscopic swallowing study (VFSS) 3. Age between 18 and 65 years old. 4. First-time onset of stroke, with stable condition after 48 hours. 5. There are no cognitive impairments, such as aphasia, auditory comprehension disorders, attention impairments, and perceptual impairments. 6. Conscious and cooperative patients without impaired consciousness. 7. Consent obtained from the patient and their family, with signed informed consent form.

排除标准：

(1)病情恶化，出现新的脑梗死灶或脑出血灶的患者； (2)既往做过呼吸肌训练的患者； (3)具有严重的原发性心、肝、肺、肾、血液或影响其生存的严重疾病； (4)既往有精神病史或精神活性药物滥用的患者； (5)不愿意配合试验，并且拒绝签署试验知情同意书的患者；

Exclusion criteria：

(1) Patients exhibiting disease progression with radiologically confirmed new cerebral infarction or hemorrhagic lesions; (2) Individuals with a history of prior respiratory muscle training; (3) Presence of severe primary cardiac, hepatic, pulmonary, renal, or hematological diseases, or other life-threatening comorbidities; (4) Patients with documented psychiatric history or psychoactive substance abuse disorders; (5) Subjects unwilling to comply with trial protocols and voluntarily refusing to sign the informed consent form.

研究实施时间：

Study execute time：

从 From 2023-01-01 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-06-30 00:00:00 至 To 2025-12-31 00:00:00  

干预措施：

Interventions：

组别：

对照组

样本量：

47

Group：

control group

Sample size：

干预措施：

对照组:神经外科常规护理+吞咽功能训练 (1)以《中国脑血管病防治指南》为参考，针对患者的临床症状以临床医学内科治疗为基础，包括控制血压及颅内高压、体温、血糖营养支持、防治应激性溃疡、维持水盐电解质平衡、常规康复训练等相应措施。 (2)常规吞咽功能训练:包括直接训练、间接训练 1)直接训练:是指采取相应的措施直接经口进食。进食的环境选安静、舒适，餐具选柄粗、柄长、匙面小，难以黏上食物、边缘钝的匙羹;进食的体位取坐位或仰卧位 30°;头部向前，偏瘫侧肩部以枕垫起，喂食者位于患者健侧:食物应首选偏凉糊状食物，放在健侧舌后部或健侧峡部，有利于食物的吞咽:一口量的训练控制好进食的速度，防止食物进入过快而发生误咽，根据不同的病人选择低头吞咽法侧方吞咽法、仰头吞咽法等。 2)间接训练:给予冰刺激、酸刺激、口腔运动训练、shaker 训练声门上训练及门德尔松手法等。 3)干预时间-直接训练:3次/d,饭前进行，间接训练:2次/d，20-30min/次，千预8周

干预措施代码：

Intervention：

Control group: Routine neurosurgical nursing care + swallowing function training Referring to the "Chinese Guidelines for the Prevention and Treatment of Cerebrovascular Disease," the clinical symptoms of patients were treated based on clinical medicine. The treatment included controlling blood pressure and intracranial hypertension, body temperature, blood glucose, nutritional support, preventing stress ulcers, maintaining water and electrolyte balance, and routine rehabilitation training. Routine swallowing function training: including direct training and indirect training. Direct training: This refers to taking measures to eat directly through the mouth. The eating environment should be quiet and comfortable. The utensils should be spoons with thick handles, long handles, small spoon surfaces, and blunt edges that are not easy to stick to food. The eating position should be sitting or semi-reclining at 30°. The head should be tilted forward, and the hemiplegic side shoulder should be padded with a pillow. The feeder should be on the healthy side of the patient. The food should be cool and mushy first, placed on the back of the tongue or the pharyngeal side of the healthy side, which is conducive to swallowing. The training of one mouthful should control the speed of eating to prevent food from entering too quickly and causing aspiration. Different patients can choose different swallowing methods such as chin tuck swallow, lateral swallow, and head-back swallow. Indirect training: This includes cold stimulation, sour stimulation, oral motor training, Shaker exercise, supraglottic swallow training, and Mendelsohn maneuver. Intervention time: Direct training: 3 times/day, before meals. Indirect training: 2 times/day, 20–30 min/time, for 8 weeks.

Intervention code：

组别：

呼吸肌抗阻训练组

样本量：

47

Group：

Respiratory Muscle Resistance Training Group

Sample size：

干预措施：

(二)干预组(呼吸肌抗阻训练组):在对照组的基础上实施呼吸肌抗阻训练 (1)干预措施 1)横膈肌训练(strengthen the diaphragm)，又称腹部重锤负荷训练法:嘱患者取屈膝仰卧位，先进行3-5次腹式-缩唇呼吸，然后在腹部放置一沙袋，重量为1.5~2.5 kg，随着训练进程逐步增至5~10 kg，腹部负荷量大小以患者能顺利完成10次腹式呼吸为准，沙袋重量可以根据患者实际情况调整。 2)吸气肌训练: ①选用 PowerBreathe 呼吸训练器作为训练用具，患者取坐于靠背椅子上，将呼吸训练器置于手中，嘱患者先做 2-3 次腹式-缩唇呼吸后 将仪器咬嘴放到嘴里，上下齿咬紧牙垫，尽最大能力尽快用力吸气，然后用 嘴快速呼气。 ②训练开始前，根据患者最大吸气压(MIP)设置初始训练的阻力值每位患者的训练阻力强度为自己 MIP 值的30%，维持1周后以每周5%~10%的强度逐渐递增，至第6周末增至到70%的最大MIP，继续保持以 70%的 MP 最大负荷进行训练。 (2)干预时间 每天3次，每次20-30分钟，每周至少5天，共干预8周。

干预措施代码：

Intervention：

Intervention Group (Respiratory Muscle Resistance Training Group): Respiratory muscle resistance training was implemented on the basis of the control group. Intervention measures Diaphragm training (strengthen the diaphragm), also known as abdominal weighted load training: The patient was instructed to lie supine with knees flexed and first perform 3–5 abdominal-lip pursed breaths. Then, a sandbag weighing 1.5–2.5 kg was placed on the abdomen, which could be gradually increased to 5–10 kg with the progress of training. The load on the abdomen was adjusted according to the patient’s ability to complete 10 abdominal breaths. The weight of the sandbag could be adjusted according to the patient’s actual condition. Inspiratory muscle training: The PowerBreathe breathing trainer was selected as the training device. The patient sat on a chair with a backrest and held the breathing trainer in hand. After performing 2–3 abdominal-lip pursed breaths, the patient was instructed to place the mouthpiece of the device in the mouth, bite the bite block with the upper and lower teeth, and then inhale as quickly and forcefully as possible. After that, the patient exhaled rapidly through the mouth. Before the start of the training, the initial resistance value was set according to the patient’s maximal inspiratory pressure (MIP). The training resistance intensity for each patient was set at 30% of their MIP value. After 1 week, the intensity was gradually increased by 5%–10% per week, reaching 70% of the maximum MIP by the end of the sixth week. The training continued at 70% of the maximum load. Intervention time: Three times per day, 20–30 minutes each time, at least five times per week, for a total of 8 weeks.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 浙江 

市(区县)：

  

Country：

China 

Province：

ZheJiang 

City：

 

单位(医院)：

湖州市第一人民医院 

单位级别：

三甲 

Institution
hospital：

Huzhou First People's Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

吞咽功能

指标类型：

主要指标

Outcome：

swallowing function

Type：

Primary indicator

测量时间点：

测量方法：

洼田饮水试验，进食评估问卷调查工具，标准吞咽功能评分，吞咽功能改善时间

Measure time point of outcome：

Measure method：

指标中文名：

呼吸肌功能

指标类型：

次要指标

Outcome：

Respiratory Muscle Function

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

肺功能

指标类型：

次要指标

Outcome：

Pulmonary Function

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

吸入性肺炎发生率

指标类型：

次要指标

Outcome：

incidence of aspiration pneumonia

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 65 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）：

课题组成员用信封法确定，单数对照组，双数实验组，产生随机数列

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

The research group members employed the envelope method to determine the assignment of subjects, where odd numbers were allocated to the control group and even numbers to the experimental group, thereby generating a random sequence.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

隐蔽分组采用双盲法（Double-blind）：受试者和研究者均不知分组。

Blinding：

Double-Blinding: Both Participants and Researchers Are Unaware of Group Allocation

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）：

zhongxingming@126.com

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

zhongxingming@126.com

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：

一、病例记录表（CRF）部分 1. 基本信息 患者编号、姓名缩写（需脱敏）、性别、年龄、卒中类型（出血性/缺血性）、发病时间、吞咽障碍程度等。 2. 干预数据 呼吸机抗阻训练方案：参数（压力、频率、时长）、治疗周期、依从性记录（实际完成次数/计划次数）。 对照组信息：常规吞咽训练方法、频次等。 3. 评估指标 主要疗效指标：如VFSS评分、SSA评分。 次要指标：生活质量量表、并发症等。 时间节点：基线、治疗中期、治疗结束、随访期。 4. 质量控制 数据填写人签名及日期、双人核对。 备注栏：记录数据异常或缺失原因。 二、电子采集管理系统（EDC）部分 1. 系统基本信息 系统名称：注明使用的电子数据采集系统（如REDCap、ClinCapture或国内平台如医渡云等）。 系统版本：标注软件版本号及认证信息（如符合21 CFR Part 11或GCP标准）。 访问权限：分级权限管理（研究者仅可查看本中心数据，管理员可导出全数据）。 2. 数据安全与合规 数据加密：说明数据传输（SSL/TLS）和存储（AES256加密）的安全措施。 审计追踪：系统是否自动记录操作日志（如修改记录、操作人、时间戳）。 伦理合规：说明系统符合《个人信息保护法》及《涉及人的生物医学研究伦理审查办法》。 3. 数据流程管理 录入流程： 由经过培训的研究护士/医师录入，实时校验（如数值范围、逻辑矛盾报警）。 影像数据（如VFSS视频）需上传至系统并关联患者编号。 数据核查： 每周由数据管理员导出异常值报告（如呼吸机参数超出预设范围）。 第三方监查员（CRA）定期远程核查数据一致性（EDC vs 纸质CRF）。 数据锁定： 研究结束后由PI审核并电子签名锁定数据，锁定后仅可查看不可修改。 4. 存储与备份 存储位置：说明服务器位置（如医院本地服务器/云端托管），国内数据需存储于境内服务器。 备份策略：每日增量备份 + 每周全量备份，备份文件加密后存储于独立硬盘。

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

I. Case Report Form (CRF) Section 1. Basic Information Patient ID, Abbreviated Name (De-identified), Gender, Age, Stroke Type (Hemorrhagic/Ischemic), Onset Time, Degree of Dysphagia, etc. Ethics 2. Intervention Data Mechanical Insufflation-Exsufflation Training Protocol: Parameters (pressure, frequency, duration), treatment cycle, compliance records (actual number of sessions completed/number of planned sessions). Control Group Information: Conventional swallowing training methods, frequency, etc. 3. Evaluation Indicators Primary Efficacy Indicators: Such as VFSS score, SSA score. Secondary Indicators: Quality of life questionnaire, complications, etc. Time Points: Baseline, mid-treatment, end of treatment, follow-up period. 4. Quality Control Data Entry Person's Signature and Date, Double-checking. Notes Section: Record reasons for data anomalies or missing data. II. Electronic Data Capture (EDC) System Section 1. System Basic Information System Name: Specify the electronic data capture system used (e.g., REDCap, ClinCapture, or domestic platforms such as Yiduyun). System Version: Indicate the software version number and certification information (e.g., compliance with 21 CFR Part 11 or GCP standards). Access Permissions: Hierarchical permission management (investigators can only view data from their own center, while administrators can export all data). 2. Data Security and Compliance Data Encryption: Explain data security measures during transmission (SSL/TLS) and storage (AES256 encryption). Audit Trail: Whether the system automatically records operation logs (such as modification records, operator, timestamp). Ethical Compliance: Explain that the system complies with the "Personal Information Protection Law" and the "Ethical Review Measures for Biomedical Research Involving Human Beings." 3. Data Process Management Data Entry Process: Data entry by trained research nurses/physicians with real-time validation (e.g., value range, logical contradiction alerts). Imaging data (such as VFSS videos) must be uploaded to the system and linked to the patient ID. Data Verification: Weekly export of abnormal value reports by data managers (e.g., mechanical insufflation-exsufflation parameters exceeding preset ranges). Regular remote data consistency checks by third-party monitors (CRA) (EDC vs. paper CRF). Data Locking: After the study ends, the principal investigator (PI) reviews and electronically signs to lock the data, which can only be viewed and not modified after locking. 4. Storage and Backup Storage Location: Specify the server location (e.g., hospital local server/cloud hosting), with domestic data required to be stored on domestic servers. Backup Strategy: Daily incremental backups + weekly full backups, with backup files encrypted and stored on an independent hard drive.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-06-20 17:30:26