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Trial search Nation, Province(City) Code of disease Primary sponsor(s) Secondary sponsor(s) Funding source Recruiting status Register status Measure Ethical committee Study type

Research and Development of Key Technologies for multimodal rehabilitation of post-tuberculosis lung Disease in Xinjiang Region and Homogeneous Application Research at the Grassroots level

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注册号：

Registration number：

ChiCTR2500113642 

最近更新日期：

Date of Last Refreshed on：

2025-12-01 17:27:15 

注册时间：

Date of Registration：

2025-12-01 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

新疆地区结核后肺病多模态康复关键技术研发与基层同质化应用研究

Public title：

Research and Development of Key Technologies for multimodal rehabilitation of post-tuberculosis lung Disease in Xinjiang Region and Homogeneous Application Research at the Grassroots level

注册题目简写：

English Acronym：

研究课题的正式科学名称：

新疆地区结核后肺病多模态康复关键技术研发与基层同质化应用研究

Scientific title：

Research and Development of Key Technologies for multimodal rehabilitation of post-tuberculosis lung Disease in Xinjiang Region and Homogeneous Application Research at the Grassroots level

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：

梁颖 

研究负责人：

梁颖;姚晓飞 

Applicant：

Ying Liang 

Study leader：

Ying Liang;Xiaofei Yao 

申请注册联系人电话：

Applicant telephone：

+86 908 572 6932

研究负责人电话：

Study leader's telephone：

+86 908 572 6932

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：

15270973720@163.com

研究负责人电子邮件：

Study leader's E-mail：

15270973720@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：

江西省南昌市西湖区广场南路133号

研究负责人通讯地址：

新疆维吾尔自治区克孜勒苏柯尔克孜自治州阿克陶县南大街8号;江西省南昌市西湖区广场南路133号

Applicant address：

No. 133, South Square Road, Xi hu District, Nanchang City, Jiangxi Province

Study leader's address：

No. 8 South Street, Aktao County, Kizilsu Kyrgyz Autonomous Prefecture, Xinjiang Uygur Autonomous Region;No. 133, South Square Road, Xi hu District, Nanchang City, Jiangxi Province

申请注册联系人邮政编码：

Applicant postcode：

330000

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

南昌大学附属康复医院

Applicant's institution：

Nanchang University Affiliated Rehabilitation Hospital

研究负责人所在单位：

阿克陶县人民医院;南昌大学附属康复医院

Affiliation of the Leader：

Aktao County People's Hospital;Nanchang University Affiliated Rehabilitation Hospital

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：

AKTXYY-KY-CH-2025-059

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：

阿克陶县人民医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Aktao County People's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2025-11-25 00:00:00

伦理委员会联系人：

阿布都赛丁

Contact Name of the ethic committee：

Abdusadin

伦理委员会联系地址：

新疆维吾尔自治区克孜勒苏柯尔克孜自治州阿克陶县南大街8号

Contact Address of the ethic committee：

No. 8 South Street, Aktao County, Kizilsu Kyrgyz Autonomous Prefecture, Xinjiang Uygur Autonomous Region

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 177 9908 2525

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：

阿克陶县人民医院

Primary sponsor：

Aktao County People's Hospital

研究实施负责（组长）单位地址：

新疆维吾尔自治区克孜勒苏柯尔克孜自治州阿克陶县南大街8号

Primary sponsor's address：

No. 8 South Street, Aktao County, Kizilsu Kyrgyz Autonomous Prefecture, Xinjiang Uygur Autonomous Region

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

新疆维吾尔自治区

市(区县)：

Country：

China

Province：

Xinjiang Uyghur Autonomous Region

City：

单位(医院)：

阿克陶县人民医院

具体地址：

新疆维吾尔自治区克孜勒苏柯尔克孜自治州阿克陶县南大街8号

Institution
hospital：

Aktao County People's Hospital

Address：

No. 8 South Street, Aktao County, Kizilsu Kyrgyz Autonomous Prefecture, Xinjiang Uygur Autonomous Region

经费或物资来源：

阿克陶县人民医院科研专项经费（智力援疆）

Source(s) of funding：

Aktao County People's Hospital Research Special Fund (Intelligence Assistance to Xinjiang)

Target disease：

Post tuberculosis lung disease

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：

本研究目的在于为新疆地区结核后肺病患者提供全面、规范的康复治疗方案，以改善患者生活质量，降低致残率和再入院率。同时，通过标准化培训与管理，提升基层医务人员的康复治疗能力，推动新疆地区康复医疗资源的建设与发展。  

Objectives of Study：

The purpose of this study is to provide a comprehensive and standardized rehabilitation treatment plan for patients with post tuberculosis lung disease in Xinjiang, in order to improve their quality of life, reduce disability and readmission rates. At the same time, through standardized training and management, we aim to enhance the rehabilitation treatment capabilities of grassroots medical personnel and promote the construction and development of rehabilitation medical resources in Xinjiang.

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.年龄在 18 岁及以上； 2.经临床诊断为肺结核，且已完成规范抗结核治疗且痰菌转阴后6个月以上； 3.存在 PTLD 相关症状，如气短、咳嗽、运动耐力下降等； 4.经肺功能检查FEV1/FVC <70%； 5.胸部高分辨率CT确认为肺纤维化或支气管扩张患者； 6.自愿参与本研究，并签署知情同意书。

Inclusion criteria

1.Age 18 and above; 2.Diagnosed clinically as pulmonary tuberculosis, and have completed standardized anti tuberculosis treatment and sputum bacteria have turned negative for more than 6 months; 3.There are PTLD related symptoms, such as shortness of breath, cough, decreased exercise endurance, etc; 4.Pulmonary function test shows FEV1/FVC<70%; 5.High resolution chest CT confirms patients with pulmonary fibrosis or bronchiectasis; 6.Voluntarily participate in this study and sign an informed consent form.

排除标准：

1.活动性结核感染； 2.合并重度肺动脉高压； 3.精神疾病或认知障碍（MMSE＜24分），无法配合研究流程； 4.正在参与其他可能影响本研究结果的临床试验。

Exclusion criteria：

1.Active tuberculosis infection; 2.Combined with severe pulmonary arterial hypertension; 3.Mental illness or cognitive impairment (MMSE score<24), unable to cooperate with the research process; 4.I am currently participating in other clinical trials that may affect the results of this study.

研究实施时间：

Study execute time：

从 From 2025-06-12 00:00:00至 To 2026-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-12-01 00:00:00 至 To 2026-06-01 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

43

Group：

Experimental group

Sample size：

干预措施：

试验组：在对照组（临床常规治疗，包括临床对症药物治疗与护理）的基础上，试验组患者将增加综合康复干预方案，具体包括以下内容： （1）肺功能康复：由专业康复治疗师对患者进行一对一的呼吸功能训练指导，训练内容包括腹式呼吸、缩唇呼吸等，每次训练时间为30分钟，每天进行2次，每周训练5天，持续12周。腹式呼吸训练要求患者平卧或半卧位，一手放在腹部，通过鼻吸气使腹部隆起，然后通过口缓慢呼气使腹部下陷，如此反复进行。缩唇呼吸训练则是让患者通过缩拢嘴唇，像吹口哨一样缓慢呼气，以增加气道压力，防止气道过早闭合，每次呼气持续4-6秒。 （2）运动功能康复：根据患者的具体情况，制定个性化的运动康复计划，包括有氧运动、力量训练和柔韧性训练等。有氧运动如功率自行车、慢走、快走等，每周进行3-5次，每次持续15-30分钟；力量训练包括上下肢的力量练习，如沙袋、弹力带训练等，每周进行2-3次，每次训练3组，每组10-15次；柔韧性训练如八段锦、新疆民族舞蹈等，每周进行2-3次，每次持续15-20分钟。在运动过程中，将有专业的康复治疗师进行现场指导和监督，确保患者正确完成运动动作，避免运动损伤；同时，严格监测患者心率、血压等生命指标，防止运动后症状的诱发性加重。 （3）心理干预：由心理医生对患者进行心理评估和干预。心理干预包括认知行为疗法、支持性心理治疗和放松训练等方法。认知行为疗法通过帮助患者识别和改变负面的思维模式和行为习惯，减轻焦虑、抑郁等不良情绪；支持性心理治疗则通过倾听、共情和鼓励等方式，给予患者情感上的支持和安慰，增强其应对疾病的信心；放松训练如渐进性肌肉松弛训练、深呼吸放松训练等，可帮助患者缓解紧张情绪，减轻身体的应激反应。心理干预每周进行1次，每次持续30-45分钟，持续12周。 （4）营养支持：依据患者营养状况和病情，制定个性化的营养支持方案，包括食物种类、摄入量、餐次分配等。饮食计划注重提供高蛋白、高热量、高维生素、易消化的食物，如瘦肉、鱼类、蛋类、豆类、新鲜蔬菜和水果等，以满足患者康复所需的营养。同时，对于存在营养不良或摄入不足的患者，将给予口服营养补充剂或肠内营养支持。营养支持将持续监督和干预12周。 （5）出院指导与远程监督：患者出院后，将获得详细的出院指导，包括康复训练计划、饮食注意事项、药物使用说明、定期复查安排等。康复训练计划将根据患者在院期间的康复情况制定，明确训练内容、频率、强度和注意事项。同时，建立远程监督机制，通过电话随访、微信沟通等方式，定期了解患者的康复进展和存在的问题，给予及时的指导和调整建议。远程监督每周进行1-2次，持续12周。

干预措施代码：

Intervention：

Experimental group: On the basis of the control group (clinical routine treatment, including clinical symptomatic drug treatment and nursing), patients in the experimental group will receive a comprehensive rehabilitation intervention plan, which includes the following contents: (1) Pulmonary function rehabilitation: Professional rehabilitation therapists provide one-on-one respiratory function training guidance to patients, including abdominal breathing, pursed lip breathing, etc. Each training session lasts for 30 minutes, twice a day, 5 days a week, and lasts for 12 weeks. Abdominal breathing training requires patients to lie flat or semi flat, place one hand on their abdomen, inhale through the nose to make the abdomen rise, and then slowly exhale through the mouth to make the abdomen sink, repeating this process. Lip pursed breathing training involves patients contracting their lips and exhaling slowly like whistling to increase airway pressure and prevent premature closure. Each exhalation lasts for 4-6 seconds. (2) Sports rehabilitation: Develop personalized sports rehabilitation plans based on the patient's specific condition, including aerobic exercise, strength training, and flexibility training. Aerobic exercise such as power cycling, slow walking, brisk walking, etc., 3-5 times a week, lasting 15-30 minutes each time; Strength training includes upper and lower limb strength exercises, such as sandbag and elastic band training, 2-3 times a week, with 3 groups trained each time, 10-15 times per group; Flexibility training, such as Eight Section Brocade and Xinjiang Ethnic Dance, is conducted 2-3 times a week for 15-20 minutes each time. During the exercise process, professional rehabilitation therapists will provide on-site guidance and supervision to ensure that patients complete the exercise movements correctly and avoid sports injuries; At the same time, strict monitoring of vital indicators such as heart rate and blood pressure is necessary to prevent the exacerbation of symptoms after exercise. (3) Psychological intervention: A psychologist conducts psychological assessment and intervention on patients. Psychological intervention includes methods such as cognitive-behavioral therapy, supportive psychotherapy, and relaxation training. Cognitive behavioral therapy helps patients identify and change negative thinking patterns and behavioral habits, reducing negative emotions such as anxiety and depression; Supportive psychotherapy provides emotional support and comfort to patients through listening, empathy, and encouragement, enhancing their confidence in coping with the disease; Relaxation training such as progressive muscle relaxation training, deep breathing relaxation training, etc. can help patients relieve tension and reduce the body's stress response. Psychological intervention should be conducted once a week for 30-45 minutes each time, lasting for 12 weeks. (4) Nutritional support: Develop personalized nutritional support plans based on the patient's nutritional status and condition, including food types, intake, meal allocation, etc. The dietary plan focuses on providing high protein, high calorie, high vitamin, and easily digestible foods such as lean meat, fish, eggs, beans, fresh vegetables, and fruits to meet the nutritional needs of the patient's recovery. Meanwhile, for patients with malnutrition or insufficient intake, oral nutritional supplements or enteral nutrition support will be provided. Nutritional support will be continuously monitored and intervened for 12 weeks. (5) Discharge guidance and remote supervision: After discharge, patients will receive detailed discharge guidance, including rehabilitation training plans, dietary precautions, medication usage instructions, regular follow-up arrangements, etc. The rehabilitation training plan will be developed based on the patient's rehabilitation situation during their stay in the hospital, specifying the training content, frequency, intensity, and precautions. At the same time, establish a remote supervision mechanism to regularly monitor patients' rehabilitation progress and existing problems through telephone follow-up, WeChat communication, and other means, and provide timely guidance and adjustment suggestions. Remote supervision is conducted 1-2 times a week for 12 weeks.

Intervention code：

组别：

对照组

样本量：

43

Group：

Control group

Sample size：

干预措施：

对照组患者将接受临床常规治疗，包括临床对症治疗与护理。在药物治疗方面，将根据患者的症状和病原学检查结果，合理使用抗生素进行抗感染治疗，同时辅以祛痰药物、支气管扩张剂等对症治疗药物，以缓解患者的咳嗽、咳痰、呼吸困难等症状。对于存在发热的患者，将采用物理降温或药物降温的方式，以提高患者的舒适度。在护理方面，医护人员将密切观察患者的病情变化，包括生命体征、症状和体征等，及时发现并报告任何异常情况。同时，将注重呼吸道管理，如指导患者有效咳嗽咳痰、进行雾化吸入治疗等，以保持呼吸道通畅，改善肺功能。此外，还将根据患者的营养状况，提供合理的饮食建议和营养支持，以增强患者的体质和免疫力。

干预措施代码：

Intervention：

The control group patients will receive routine clinical treatment, including symptomatic treatment and nursing care. In terms of drug therapy, antibiotics will be used reasonably for anti infection treatment based on the patient's symptoms and pathogen examination results, while symptomatic treatment drugs such as expectorants and bronchodilators will be supplemented to alleviate the patient's symptoms such as cough, sputum, and difficulty breathing. For patients with fever, physical cooling or medication cooling will be used to improve patient comfort. In terms of nursing, medical staff will closely observe changes in the patient's condition, including vital signs, symptoms, and signs, and promptly detect and report any abnormal situations. At the same time, attention will be paid to respiratory management, such as guiding patients to effectively cough up phlegm, and performing nebulized inhalation therapy to maintain airway patency and improve lung function. In addition, reasonable dietary recommendations and nutritional support will be provided based on the patient's nutritional status to enhance their physical fitness and immunity.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 新疆维吾尔自治区 

市(区县)：

  

Country：

China 

Province：

Xinjiang Uyghur Autonomous Region 

City：

 

单位(医院)：

阿克陶县人民医院 

单位级别：

二级 

Institution
hospital：

Aktao County People's Hospital

Level of the institution：

Secondary

测量指标：

Outcomes：

指标中文名：

一秒呼气量

指标类型：

主要指标

Outcome：

FEV1/FVC

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

6分钟步行试验

指标类型：

主要指标

Outcome：

A 6-minute walk test

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

NYHA心功能分级

指标类型：

次要指标

Outcome：

New York Heart Association

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

疾病耻感量表

指标类型：

次要指标

Outcome：

Disease Shame 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：

汉密尔顿焦虑量表

指标类型：

次要指标

Outcome：

Hamilton Anxiety 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：

汉密尔顿抑郁量表

指标类型：

次要指标

Outcome：

Hamilton Depression 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：

SF36生活质量量表

指标类型：

次要指标

Outcome：

Short Form 36

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

日常生活能力量表

指标类型：

次要指标

Outcome：

Activity of Daily Living Scale

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 18 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）：

本研究采取区组随机对照设计，通过Stata 18.0软件生成随机序列。

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

This study adopted a block randomized controlled design, generating random sequences using Stata 18.0 software.

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：

对评估者设盲

Blinding：

Blind the evaluators

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：

本研究采用纸质病例记录表（CRF）收集患者基线信息、治疗方案、实验室检测结果及影像学报告，同时使用标准化评估设备及量表（FEV1/FVC、6MWT）采集主观指标；原始纸质文件由双人核签后归档保存。数据通过加密电子表格系统（Microsoft Excel 365）进行电子化管理，实现双人独立录入、逻辑校验、修订追踪，所有数据存储于医院等保2.0三级服务器及科室临床试验实施管理柜中。

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

This study used a paper case record form (CRF) to collect baseline information, treatment plans, laboratory test results, and imaging reports from patients, while using standardized evaluation equipment and scales (FEV1/FVC, 6MWT) to collect subjective indicators; The original paper documents shall be archived and saved after being signed by two persons. The data is electronically managed through an encrypted spreadsheet system (Microsoft Excel 365), enabling two people to independently input, perform logical verification, and track revisions. All data is stored on the hospital's Level 2 security server and departmental clinical trial implementation management cabinet.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

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  2025-12-01 17:26:21
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