ChiCTR2400079407 版本V1.0 版本创建时间2024/01/03 08:42:10 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：

 ChiCTR2400079407 

最近更新日期：

Date of Last Refreshed on：

 2024-01-03 08:41:57 

注册时间：

Date of Registration：

 2024-01-03 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

间歇性运动训练与持续性运动训练在自我管理能力较低的COPD患者身上应用情况的对比

Public title：

To compare the application of interval exercise training and continuous exercise training in COPD patients with low self-management ability

注册题目简写：

English Acronym：

研究课题的正式科学名称：

间歇性运动训练与持续性运动训练在自我管理能力较低的COPD患者身上应用情况的对比

Scientific title：

To compare the application of interval exercise training and continuous exercise training in COPD patients with low self-management ability

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：

郑佳琪 

研究负责人：

杨旅军 

Applicant：

Jiaqi Zheng 

Study leader：

Lvjun Yang 

申请注册联系人电话：

Applicant telephone：

 +86 134 1435 3557

研究负责人电话：

Study leader's
telephone：

+86 150 1976 1830

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：

 22jqzheng@stu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

 yanglujun726@hotmail.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：

广东省汕头市金平区石炮台街道新陵路22号

研究负责人通讯地址：

广东省汕头市金平区东厦北路69号汕头大学医学院第二附属医院

Applicant address：

No. 22 Xinling road, Shipaotai street, Jinping district, Shantou city, Guangdong province

Study leader's address：

Dongxiabei Road69, Shantou, Guangdong

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：

汕头大学医学院

Applicant's institution：

Shantou University Medical College

研究负责人所在单位：

汕头大学医学院第二附属医院

Affiliation of the Leader：

Second Affiliated Hospital of Shantou University Medical College

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：

 汕大医附二伦审科 (2023-53) 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：

汕头大学医学院第二附属医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of the Second Affiliated Hospital of Shantou University Medical College

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-09-21 00:00:00

伦理委员会联系人：

王长智

Contact Name of the ethic committee：

Zhangzhi Wang

伦理委员会联系地址：

广东省汕头市金平区东厦北路

Contact Address of the ethic committee：

Dongxiabei Road, Shantou, Guangdong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 754 8891 5938

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 sdyfeyllb@163.com

研究实施负责（组长）单位：

汕头大学医学院第二附属医院

Primary sponsor：

Second Affiliated Hospital of Shantou University Medical College

研究实施负责（组长）单位地址：

广东省汕头市金平区东厦北路69号汕头大学医学院第二附属医院

Primary sponsor's address：

Dongxiabei Road69, Shantou, Guangdong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广东省

市(区县)：

汕头市

Country：

China

Province：

Guangdong

City：

shantou

单位(医院)：

汕头大学医学院第二附属医院

具体地址：

广东省汕头市金平区东厦北路69号

Institution
hospital：

Second Affiliated Hospital of Shantou University Medical College

Address：

Dongxiabei Road69, Shantou, Guangdong

经费或物资来源：

自筹

Source(s) of funding：

self-financing

研究疾病：

慢性阻塞性肺疾病  

Target disease：

Chronic obstructive pulmonary disease

研究疾病代码：

H0108

Target disease code：

H0108

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：

横断面 

Study design：

Cross-sectional 

研究目的：

设计两个详细的肺康复运动训练研究方案，分别是低强度持续性运动训练和高强度间歇性运动训练，以评估哪种运动训练形式更适合中国的自我管理能力较差的COPD患者，并评估其短期有效性。  

Objectives of Study：

Two detailed pulmonary rehabilitation exercise training studies, low-intensity continuous exercise training and high-intensity intermittent exercise training, were designed to evaluate which form of exercise training is more suitable for COPD patients with poor self-management ability in China, and to evaluate its short-term effectiveness.

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. 确诊慢性阻塞性肺疾病 2. 患者病情恢复到急性加重前的状态 3. 自我管理能力低 4. 无治疗禁忌症

Inclusion criteria

1. patients who had been diagnosed with COPD, regardless of age and gender 2. the condition returned to a state before acute exacerbation 3. low self-management ability 4. patients who had no contraindications to treatment

排除标准：

1. 怀孕 2. 半年内参与过其他肺康复活动 3. 患有可能会对研究结果造成影响的其他肺部疾病，如哮喘、间质性肺炎、肺癌或者严重的支气管扩张等 4. 合并其他严重疾病，如急性心肌梗死、脑卒中等 5. 曾做过关节置换术或运动能力受限 6. 已有固定运动训练项目

Exclusion criteria：

1. pregnancy 2. participation in other pulmonary rehabilitation exercise programs within six months 3. had other comorbid lung diseases that would potentially interfere with study outcomes (i.e. predominant asthma based on physician diagnosis, active lung cancer, interstitial lung disease, severe bronchiectasis) 4. had other serious comorbid lung diseases (i.e. acute myocardial infarction, stroke) 5. previous joint replacement surgery or limited mobility 6. had fixed sports training programs

研究实施时间：

Study execute time：

从 From 2023-09-25 00:00:00至 To 2024-09-25 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-01-05 00:00:00 至 To 2024-09-25 00:00:00

干预措施：

Interventions：

组别：

对照组

样本量：

 33

Group：

group 3

Sample size：

干预措施：

常规护理

干预措施代码：

Intervention：

non-intervention group

Intervention code：

组别：

试验组1

样本量：

 33

Group：

group 1

Sample size：

干预措施：

间歇性运动训练：参与者将由受过肺康复培训的专业临床护士进行运动训练指导，行间歇性运动训练， 由热身训练、有氧训练、力量训练、平衡训练及放松组成，运动强度控制在 70%~90% 的最大心率，并在出院前学会如何按照运动训练方案进行锻炼。运动频率为每周 2 次或 3 次，训练周期为 12 周。参与者可在微信平台上与研究者联系，同组的参与者将被分配到同一个微信群，以确保他们出院后亦能接受有效的远程指导。研究者定期在微信群中以图片和视频的形式上传与肺康复相关的知识，每周与参与者进行1次一对一的视频通话，记录每个参与者的运动训练情况，确认病人是否出现不适症状及按要求完成训练。此外，每4周举行1次微信会议，时间为40min，对病人训练过程中遇到的问题进行讨论与解答。

干预措施代码：

Intervention：

the interval exercise training group: Participants will be guided by professional clinical nurses who have received training in pulmonary rehabilitation. They will perform intermittent exercise training, which consists of warm-up training, aerobic training, strength training, balance training and relaxation. The exercise intensity is controlled at 70%~90% of the maximum heart rate, and they will learn how to exercise according to the exercise training plan before discharge. The exercise frequency was 2 or 3 times a week, and the training cycle was 12 weeks. Participants can contact the researcher on the wechat platform, and participants in the same group will be assigned to the same wechat group to ensure that they can also receive effective remote guidance after discharge. The researchers regularly upload knowledge related to pulmonary rehabilitation in the form of pictures and videos in the wechat group, conduct one-on-one video calls with participants once a week, record the exercise training of each participant, confirm whether the patient has discomfort symptoms and complete the training as required. In addition, a wechat meeting was held every 4 weeks, lasting 40 minutes, to discuss and answer the problems encountered in the training process of patients. Participants will be guided by professional clinical nurses who have received training in pulmonary rehabilitation. They will perform intermittent exercise training, which consists of warm-up training, aerobic training, strength training, balance training and relaxation. The exercise intensity is controlled at 70%~90% of the maximum heart rate, and they will learn how to exercise according to the exercise training plan before discharge. The exercise frequency was 2 or 3 times a week, and the training cycle was 12 weeks. Participants can contact the researcher on the wechat platform, and participants in the same group will be assigned to the same wechat group to ensure that they can also receive effective remote guidance after discharge. The researchers regularly upload knowledge related to pulmonary rehabilitation in the form of pictures and videos in the wechat group, conduct one-on-one video calls with participants once a week, record the exercise training of each participant, confirm whether the patient has discomfort symptoms and complete the training as required. In addition, a wechat meeting was held every 4 weeks, lasting 40 minutes, to discuss and answer the problems encountered in the training process of patients.

Intervention code：

组别：

试验组2

样本量：

 33

Group：

group 2

Sample size：

干预措施：

持续性运动训练：参与者将由受过肺康复培训的专业临床护士进行运动训练指导，行持续性运动训练， 由热身训练、有氧训练、力量训练、平衡训练及放松组成，运动强度控制在30%~50% 的最大心率，并在出院前学会如何按照运动训练方案进行锻炼。运动频率为每周 2 次或 3 次，训练周期为 12 周。参与者可在微信平台上与研究者联系，同组的参与者将被分配到同一个微信群，以确保他们出院后亦能接受有效的远程指导。研究者定期在微信群中以图片和视频的形式上传与肺康复相关的知识，每周与参与者进行1次一对一的视频通话，记录每个参与者的运动训练情况，确认病人是否出现不适症状及按要求完成训练。此外，每4周举行1次微信会议，时间为40min，对病人训练过程中遇到的问题进行讨论与解答。

干预措施代码：

Intervention：

the continuous exercise training group: Participants will be guided by professional clinical nurses who have received training in pulmonary rehabilitation. They will perform continuous exercise training, which consists of warm-up training, aerobic training, strength training, balance training and relaxation. The exercise intensity is controlled at 30%~50% of the maximum heart rate. The exercise frequency was 2 or 3 times a week, and the training cycle was 12 weeks. Participants can contact the researcher on the wechat platform, and participants in the same group will be assigned to the same wechat group to ensure that they can also receive effective remote guidance after discharge. The researchers regularly upload knowledge related to pulmonary rehabilitation in the form of pictures and videos in the wechat group, conduct one-on-one video calls with participants once a week, record the exercise training of each participant, confirm whether the patient has discomfort symptoms and complete the training as required. In addition, a wechat meeting was held every 4 weeks, lasting 40 minutes, to discuss and answer the problems encountered in the training process of patients.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东省 

市(区县)：

 汕头市 

Country：

China

Province：

Guangdong

City：

单位(医院)：

 汕头大学医学院第二附属医院 

单位级别：

 三甲 

Institution
hospital：

Second Affiliated Hospital of Shantou University Medical College

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

呼吸困难程度

指标类型：

主要指标

Outcome：

Dyspnea

Type：

Primary indicator

测量时间点：

出院，出院后4周，出院后8周，出院后12周

测量方法：

COPD 患者自我评估测试问卷

Measure time point of outcome：

Measure method：

指标中文名：

运动能力

指标类型：

主要指标

Outcome：

Exercise capacity

Type：

Primary indicator

测量时间点：

出院，出院后4周，出院后8周，出院后12周

测量方法：

六分钟步行试验

Measure time point of outcome：

Measure method：

指标中文名：

生活质量

指标类型：

主要指标

Outcome：

Health-related quality of life

Type：

Primary indicator

测量时间点：

出院，出院后4周，出院后8周，出院后12周

测量方法：

圣乔治呼吸调查问卷

Measure time point of outcome：

Measure method：

指标中文名：

患者参与度

指标类型：

次要指标

Outcome：

Degree of participation in the exercise program

Type：

Secondary indicator

测量时间点：

出院后4周，出院后8周，出院后12周

测量方法：

记录了实验组 1 与实验组 2 的参与者在微信平台上发送的信息数量及发送的内容(包括文字、语音、图片、视频等形式)，并对每个参与者在该平台上的活跃度和对疾病的关注程度进行评估

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 0 岁 years
最大 Max age 100 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）：

对所有患者编号为 1 到 99，由研究者通过随机数生成器生成随机数，并对随机数进行重新编码，将 1 到 33 编号赋值为 1，设为试验组；将 34 到 66 编号赋值为 2，设为实验组2,；将35到99编号赋值为3，设为对照组。

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

All patients were numbered from 1 to 99, and random numbers were generated by the random number generator, and the random numbers were recoded, and numbers from 1 to 33 were assigned as 1, and they were set as the experimental group. Assign numbers 34 to 66 as 2, set as experimental group 2; Assign numbers 35 through 99 to 3 and set them as the control group.

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（对受试者隐藏分组）

Blinding：

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

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）：

通过邮箱联系作者

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

Email the author

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：

数据收集以研究者直接询问患者的方式进行，数据管理通过纸质版数据管理为主。

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

Data collection was conducted by researchers directly inquiring patients, and data management was mainly conducted by paper version data management.

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：

  2024-01-03 08:41:57