ChiCTR2300072208 版本V1.0 版本创建时间2023/06/06 17:35:03 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：

ChiCTR2300072208 

最近更新日期：

Date of Last Refreshed on：

2023-06-06 17:34:55 

注册时间：

Date of Registration：

2023-06-06 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

乳腺癌患者骨安全管理运动干预方案的构建与效果评价

Public title：

Construction and evaluation of bone safety management intervention program for breast cancer patients

注册题目简写：

English Acronym：

研究课题的正式科学名称：

乳腺癌患者全程骨安全管理干预方案的构建与实施效果评价

Scientific title：

Construction and implementation of whole-course bone safety management intervention program for breast cancer patients

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：

陈璐 

研究负责人：

刘均娥 

Applicant：

Chen Lu 

Study leader：

Liu June 

申请注册联系人电话：

Applicant telephone：

+86 198 0035 3831

研究负责人电话：

Study leader's telephone：

+86 185 0013 6128

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：

937177996@qq.com

研究负责人电子邮件：

Study leader's E-mail：

liujune66@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：

北京市丰台区右安门外西头条10号

研究负责人通讯地址：

北京市丰台区右安门外西头条10号

Applicant address：

Capital Medical University, Beijing, China

Study leader's address：

Capital Medical University, Beijing, China

申请注册联系人邮政编码：

Applicant postcode：

10000

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

首都医科大学

Applicant's institution：

Capital Medical University, Beijing, China

研究负责人所在单位：

首都医科大学

Affiliation of the Leader：

Capital Medical University, Beijing, 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：

Z2023SY035

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：

首都医科大学医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Capital Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

2023-05-12 00:00:00

伦理委员会联系人：

马子寅

Contact Name of the ethic committee：

Ma Ziyin

伦理委员会联系地址：

北京市丰台区右安门外西头条10号

Contact Address of the ethic committee：

Capital Medical University, Beijing, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 83911936

伦理委员会联系人邮箱：

Contact email of the ethic committee：

maziyin@ccmu.edu.cn

研究实施负责（组长）单位：

首都医科大学

Primary sponsor：

Capital Medical University, Beijing, China

研究实施负责（组长）单位地址：

北京市丰台区右安门外西头条10号

Primary sponsor's address：

Capital Medical University, 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)：

首都医科大学

具体地址：

首都医科大学

Institution
hospital：

Capital Medical University

Address：

Capital Medical University

经费或物资来源：

北京市自然科学基金（No.7222008）

Source(s) of funding：

Natural Science Foundation of Beijing（No.7222008）

Target disease：

Breast cancer

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：

开发以运动干预为主的乳腺癌患者骨安全管理干预方案，并对其干预效果进行初步评价。  

Objectives of Study：

To develop and evaluate a bone safety management intervention program for breast cancer 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病理诊断确诊为乳腺癌,知晓病情;②术后患者;③有基本的文字阅读能力,能够上网会使用微信等社交软件;④知情同意、自愿参与本次研究;⑤18 周岁≤年龄≤65 周岁。

Inclusion criteria

(i) diagnosed with breast cancer (stages I–III); (ii)post-treatment (surgery, chemotherapy or radiotherapy) ; (iii)ability to read and use the social software ; (iv) signed informed consent; (v) age between 18 and 65 years old.

排除标准：

①已复发或转移;②严重心脏病(NYHA≥3)，一年内心肌梗死或高血压未控制;③骨质疏松(股骨近端或腰椎t评分<-2.5或骨折);④同时服用影响钙和骨代谢的药物，如双膦酸盐、降钙素、甲状旁腺素、血清素、口服皮质类固醇>6个月，抗惊厥药苯妥英或卡马西平，延长肝素治疗;⑤其他影响钙和骨代谢的疾病，如甲亢、原发性甲状旁腺功能亢进、肾功能衰竭、慢性肝病、器官移植等;⑥其他严重疾病或者身体状况与锻炼相矛盾的;⑦在过去三个月内参加过锻炼计划。

Exclusion criteria：

(i) being diagnosed with another primary and/or secondary tumour or being in the metastatic stage; (ii) severe cardiac disease (NYHA ≥3), myocardial infarction within one year or uncontrolled hypertension; (iii) verified osteoporosis (proximal femur or lumbar spine T-score<-2.5 or fracture without trauma); (iv) concomitant medication affecting calcium and bone metabolism such as bisphosphonates, calcitonin, PTH, SERMs, oral corticosteroids >6 months, anticonvulsants phenytoin or carbamazepine, prolonged heparin therapy; (v) other diseases affecting calcium and bone metabolism such as hyperthyroidism, primary hyperparathyroidism, renal failure, chronic hepatic diseases, organ transplant; (vi) other severe illness or medical condition, which could be a contradiction to exercise; or (vii) to have participated in an exercise program during the previous three months.

研究实施时间：

Study execute time：

从 From 2021-12-01 00:00:00至 To 2024-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2022-01-03 00:00:00 至 To 2023-12-31 00:00:00  

干预措施：

Interventions：

组别：

干预组（可行性研究）

样本量：

10

Group：

Intervention group （Feasibility Study）

Sample size：

干预措施：

该项目包括两部分：运动干预和骨健康教育。为期12周的运动干预包括小组运动和个人运动。小组运动在第一个月每两周进行一次，通过腾讯会议在线进行的，旨在教授运动动作，如热身、阻力、拉伸和骨骼强化运动。在小组练习中，每个人都会打开摄像头，以便参与者可以跟随动作进行互动，培训师也可以评估她们的表现，并在必要时给予反馈或纠正。参与者被要求执行他们的个人运动处方，并佩戴乐心手环（MAMBO5）来跟踪她们的日常运动。手环收集的活动数据（运动时间、类型和心率）被手动上传至微信小程序，并在每周结束时由研究人员接收。之后，未来两周的新的个人运动处方会被发送到参与者。个人运动包含阻力运动和有氧运动。阻力练习包括一套8个功能练习（带式前臂外展、带式髋关节外展、带式髋关节内收、带式髋关节前屈、带式髋关节后屈、臀桥、剪刀腿和超人）的组合。练习是用体重和15磅弹力带制定的，重复次数和组数决定强度。对于有氧运动，类型取决于参与者的偏好，如慢跑、快走、游泳、骑自行车、徒步旅行等。工作强度由博格量表和最大心率（HRmax）来衡量。参与者被要求在每次锻炼前后做10分钟的热身和拉伸运动。骨骼健康教育包括风险识别和缓解、运动和安全、钙和维生素D补充、疼痛区分和应对、饮食和营养以及药物指导。每周都会向大家发送相关的微信推文。

干预措施代码：

Intervention：

The program includes two parts, exercise intervention and bone health education. The 12-week exercise intervention included group exercise and individual exercise. The group exercises were conducted fortnightly during the first month. They were delivered online through Tencent Meeting, designed to teach exercise movements, such as warm-up, resistance, stretching, and bone-strengthening exercises. During group exercise, everyone would turn on the camera so that the participants could follow the movement and interact, and the trainer could also assess their performance and give feedback or corrections when necessary. BCSs were required to implement their individual exercise prescription and wear the Life Sense band (MAMBO5) to track their daily exercise. The activity data (exercise time, type and heart rate) collected by the band were manually uploaded to an applet of WeChat and received by the researcher at the end of each week. Afterwards, the new individual exercise prescriptions for the next two weeks were delivered to BCSs. The individual exercise contained resistance and aerobic exercise. Resistant exercises include a combined set of 8 functional exercises (band forearm abduction, band hip abduction, band hip adduction, band hip anteflexion, band hip retroflexion, glute bridge, scissor kick and superman). Exercises were developed with body weight and 15 pounds elastic band, and repetitions and sets determined the intensity. For aerobic exercise, the type depends on the participants’ preference, such as jogging, brisk walking, swimming, bicycling, hiking, etc. The work intensity was measured by the Borg scale and maximum heart rate (HRmax); the latter was calculated using the Karvonen formula. The participants were required to do a 10-minute warm-up and stretching exercise before and after each workout. Bone health education consists of risk identification and mitigation, exercise and safety, calcium and vitamin D supplementation, pain distinguishing and coping, diet and nutrition, and medication instruction. Relevant tweets were sent to everyone each week.

Intervention code：

组别：

干预组（预实验研究）

样本量：

36

Group：

Intervention group (Pilot Study)

Sample size：

干预措施：

该项目包括两部分：运动干预和骨健康教育。为期12周的运动干预包括小组运动和个人运动。小组运动在第一个月每两周进行一次，通过腾讯会议在线进行的，旨在教授运动动作，如热身、阻力、拉伸和骨骼强化运动。在小组练习中，每个人都会打开摄像头，以便参与者可以跟随动作进行互动，培训师也可以评估她们的表现，并在必要时给予反馈或纠正。参与者被要求执行他们的个人运动处方，并佩戴乐心手环（MAMBO5）来跟踪她们的日常运动。手环收集的活动数据（运动时间、类型和心率）被手动上传至微信小程序，并在每周结束时由研究人员接收。之后，未来两周的新的个人运动处方会被发送到参与者。个人运动包含阻力运动和有氧运动。阻力练习包括一套8个功能练习（带式前臂外展、带式髋关节外展、带式髋关节内收、带式髋关节前屈、带式髋关节后屈、臀桥、剪刀腿和超人）的组合。练习是用体重和15磅弹力带制定的，重复次数和组数决定强度。对于有氧运动，类型取决于参与者的偏好，如慢跑、快走、游泳、骑自行车、徒步旅行等。工作强度由博格量表和最大心率（HRmax）来衡量。参与者被要求在每次锻炼前后做10分钟的热身和拉伸运动。骨骼健康教育包括风险识别和缓解、运动和安全、钙和维生素D补充、疼痛区分和应对、饮食和营养以及药物指导。每周都会向大家发送相关的微信推文。

干预措施代码：

Intervention：

The program includes two parts, exercise intervention and bone health education. The 12-week exercise intervention included group exercise and individual exercise. The group exercises were conducted fortnightly during the first month. They were delivered online through Tencent Meeting, designed to teach exercise movements, such as warm-up, resistance, stretching, and bone-strengthening exercises. During group exercise, everyone would turn on the camera so that the participants could follow the movement and interact, and the trainer could also assess their performance and give feedback or corrections when necessary. BCSs were required to implement their individual exercise prescription and wear the Life Sense band (MAMBO5) to track their daily exercise. The activity data (exercise time, type and heart rate) collected by the band were manually uploaded to an applet of WeChat and received by the researcher at the end of each week. Afterwards, the new individual exercise prescriptions for the next two weeks were delivered to BCSs. The individual exercise contained resistance and aerobic exercise. Resistant exercises include a combined set of 8 functional exercises (band forearm abduction, band hip abduction, band hip adduction, band hip anteflexion, band hip retroflexion, glute bridge, scissor kick and superman). Exercises were developed with body weight and 15 pounds elastic band, and repetitions and sets determined the intensity. For aerobic exercise, the type depends on the participants’ preference, such as jogging, brisk walking, swimming, bicycling, hiking, etc. The work intensity was measured by the Borg scale and maximum heart rate (HRmax); the latter was calculated using the Karvonen formula. The participants were required to do a 10-minute warm-up and stretching exercise before and after each workout. Bone health education consists of risk identification and mitigation, exercise and safety, calcium and vitamin D supplementation, pain distinguishing and coping, diet and nutrition, and medication instruction. Relevant tweets were sent to everyone each week.

Intervention code：

组别：

对照组（预实验研究）

样本量：

36

Group：

Control group (Pilot Study)

Sample size：

干预措施：

骨骼健康教育包括风险识别和缓解、运动和安全、钙和维生素D补充、疼痛区分和应对、饮食和营养以及药物指导。每周都会向大家发送相关的微信推文。

干预措施代码：

Intervention：

Bone health education consists of risk identification and mitigation, exercise and safety, calcium and vitamin D supplementation, pain distinguishing and coping, diet and nutrition, and medication instruction. Relevant tweets were sent to everyone each week.

Intervention code：

组别：

干预组（随机对照试验研究）

样本量：

36

Group：

Intervention group (RCT)

Sample size：

干预措施：

该项目包括两部分：运动干预和骨健康教育。为期12周的运动干预包括小组运动和个人运动。小组运动在第一个月每两周进行一次，通过腾讯会议在线进行的，旨在教授运动动作，如热身、阻力、拉伸和骨骼强化运动。在小组练习中，每个人都会打开摄像头，以便参与者可以跟随动作进行互动，培训师也可以评估她们的表现，并在必要时给予反馈或纠正。参与者被要求执行他们的个人运动处方，并佩戴乐心手环（MAMBO5）来跟踪她们的日常运动。手环收集的活动数据（运动时间、类型和心率）被手动上传至微信小程序，并在每周结束时由研究人员接收。之后，未来两周的新的个人运动处方会被发送到参与者。个人运动包含阻力运动和有氧运动。阻力练习包括一套8个功能练习（带式前臂外展、带式髋关节外展、带式髋关节内收、带式髋关节前屈、带式髋关节后屈、臀桥、剪刀腿和超人）的组合。练习是用体重和15磅弹力带制定的，重复次数和组数决定强度。对于有氧运动，类型取决于参与者的偏好，如慢跑、快走、游泳、骑自行车、徒步旅行等。工作强度由博格量表和最大心率（HRmax）来衡量。参与者被要求在每次锻炼前后做10分钟的热身和拉伸运动。骨骼健康教育包括风险识别和缓解、运动和安全、钙和维生素D补充、疼痛区分和应对、饮食和营养以及药物指导。每周都会向大家发送相关的微信推文。

干预措施代码：

Intervention：

The program includes two parts, exercise intervention and bone health education. The 12-week exercise intervention included group exercise and individual exercise. The group exercises were conducted fortnightly during the first month. They were delivered online through Tencent Meeting, designed to teach exercise movements, such as warm-up, resistance, stretching, and bone-strengthening exercises. During group exercise, everyone would turn on the camera so that the participants could follow the movement and interact, and the trainer could also assess their performance and give feedback or corrections when necessary. BCSs were required to implement their individual exercise prescription and wear the Life Sense band (MAMBO5) to track their daily exercise. The activity data (exercise time, type and heart rate) collected by the band were manually uploaded to an applet of WeChat and received by the researcher at the end of each week. Afterwards, the new individual exercise prescriptions for the next two weeks were delivered to BCSs. The individual exercise contained resistance and aerobic exercise. Resistant exercises include a combined set of 8 functional exercises (band forearm abduction, band hip abduction, band hip adduction, band hip anteflexion, band hip retroflexion, glute bridge, scissor kick and superman). Exercises were developed with body weight and 15 pounds elastic band, and repetitions and sets determined the intensity. For aerobic exercise, the type depends on the participants’ preference, such as jogging, brisk walking, swimming, bicycling, hiking, etc. The work intensity was measured by the Borg scale and maximum heart rate (HRmax); the latter was calculated using the Karvonen formula. The participants were required to do a 10-minute warm-up and stretching exercise before and after each workout. Bone health education consists of risk identification and mitigation, exercise and safety, calcium and vitamin D supplementation, pain distinguishing and coping, diet and nutrition, and medication instruction. Relevant tweets were sent to everyone each week.

Intervention code：

组别：

对照组（随机对照试验研究）

样本量：

36

Group：

Control group (RCT)

Sample size：

干预措施：

骨骼健康教育包括风险识别和缓解、运动和安全、钙和维生素D补充、疼痛区分和应对、饮食和营养以及药物指导。每周都会向大家发送相关的微信推文。

干预措施代码：

Intervention：

Bone health education consists of risk identification and mitigation, exercise and safety, calcium and vitamin D supplementation, pain distinguishing and coping, diet and nutrition, and medication instruction. Relevant tweets were sent to everyone each week.

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)：

首都医科大学附属北京世纪坛医院 

单位级别：

三甲 

Institution
hospital：

Beijing Shijitan Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

骨密度

指标类型：

主要指标

Outcome：

BMD

Type：

Primary indicator

测量时间点：

干预前，干预后，随访3个月后

测量方法：

超声骨密度仪

Measure time point of outcome：

pre-intervention, post-intervention and 3-month follow-up

Measure method：

Osteo Pro Smart ultrasound analyser，BMTech, Korean

指标中文名：

骨质疏松知识问卷

指标类型：

次要指标

Outcome：

Osteoporosis Knowledge Test

Type：

Secondary indicator

测量时间点：

干预前，干预后，随访3个月后

测量方法：

问卷

Measure time point of outcome：

pre-intervention, post-intervention and 3-month follow-up

Measure method：

Questionnaire

指标中文名：

骨质疏松自我效能量表

指标类型：

次要指标

Outcome：

Osteoporosis Self efficacy Scale

Type：

Secondary indicator

测量时间点：

干预前，干预后，随访3个月后

测量方法：

问卷

Measure time point of outcome：

pre-intervention, post-intervention and 3-month follow-up

Measure method：

Questionnaire

指标中文名：

WOMAC评分

指标类型：

次要指标

Outcome：

The Western Ontario and McMaster University Osteoarthritis Index

Type：

Secondary indicator

测量时间点：

干预前，干预后，随访3个月后

测量方法：

问卷

Measure time point of outcome：

pre-intervention, post-intervention and 3-month follow-up

Measure method：

Questionnaire

指标中文名：

心肺耐力

指标类型：

次要指标

Outcome：

aerobic endurance

Type：

Secondary indicator

测量时间点：

干预前，干预后，随访3个月后

测量方法：

2分钟踏步试验

Measure time point of outcome：

pre-intervention, post-intervention and 3-month follow-up

Measure method：

2-minute Step Test

指标中文名：

下肢肌力

指标类型：

次要指标

Outcome：

muscular strength of lower limbs

Type：

Secondary indicator

测量时间点：

干预前，干预后，随访3个月后

测量方法：

30秒椅子站立试验

Measure time point of outcome：

pre-intervention, post-intervention and 3-month follow-up

Measure method：

30-s Chair-Stand Test

指标中文名：

握力

指标类型：

次要指标

Outcome：

grip

Type：

Secondary indicator

测量时间点：

干预前，干预后，随访3个月后

测量方法：

握力计

Measure time point of outcome：

pre-intervention, post-intervention and 3-month follow-up

Measure method：

grip dynamometer

指标中文名：

上肢肌力

指标类型：

次要指标

Outcome：

muscular strength of upper limbs

Type：

Secondary indicator

测量时间点：

干预前，干预后，随访3个月后

测量方法：

30s坐立起身

Measure time point of outcome：

pre-intervention, post-intervention and 3-month follow-up

Measure method：

The 30-s Chair-Stand Test

指标中文名：

平衡能力

指标类型：

次要指标

Outcome：

balance

Type：

Secondary indicator

测量时间点：

干预前，干预后，随访3个月后

测量方法：

闭眼单脚站立测试

Measure time point of outcome：

pre-intervention, post-intervention and 3-month follow-up

Measure method：

One-Leg Standing test

指标中文名：

肩关节柔韧性

指标类型：

次要指标

Outcome：

Flexibility

Type：

Secondary indicator

测量时间点：

干预前，干预后，随访3个月后

测量方法：

抓背试验

Measure time point of outcome：

pre-intervention, post-intervention and 3-month follow-up

Measure method：

The Back Scratch Test

指标中文名：

健康状况SF-36调查问卷

指标类型：

次要指标

Outcome：

SF-36

Type：

Secondary indicator

测量时间点：

干预前，干预后，随访3个月后

测量方法：

问卷

Measure time point of outcome：

pre-intervention, post-intervention and 3-month follow-up

Measure method：

Questionnaire

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：

女性

Gender：

Female

随机方法（请说明由何人用什么方法产生随机序列）：

由课题组成员A采用Excel软件形成随机数字表。

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

Team member A uses Excel software to form a 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:

不公开/Private

盲法：

本研究对参与者、测量者实施盲法。为了确保盲法的实施，该研究主要采取了以下措施: ①招募采用统一介绍说明，概述干预内容; ②除了干预者，其他工作人员不知晓分配情况; ③测量人员和干预人员在试验的整个过程中分开，测量人员不知晓分组情况，干预人员不参与结果测量工作; ④所有的调查人员、工作人员和研究对象都不知晓测量结果和试验结果; ⑤逐一招募，研究对象互不认识，不同组分别建立微信群。

Blinding：

This study was blinded to the participants, the measurers. To ensure that blinding was implemented, the study focused on the following measures. (i) recruitment was done using a uniform introductory note outlining the intervention. (ii) Allocation was unknown to staff other than the interventionist. (iii) Surveyors and interventionists were separated throughout the trial, with surveyors unaware of groupings and interventionists uninvolved in outcome measurement. (iv)All investigators, staff and study participants were unaware of the measurements and trial results. (v)Recruitment was done on a case-by-case basis, study participants did not know each other, and separate WeChat groups were set up for different groups.

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）：

ResMan

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

ResMan

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：

数据采集通过问卷星，管理采用Excel

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

Data was collected by questionnaire star and administered by Excel

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：

  2023-06-06 17:34:55