ChiCTR2600119373 版本V1.0 版本创建时间2026/02/26 09:55:18 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：

 ChiCTR2600119373 

最近更新日期：

Date of Last Refreshed on：

 2026-02-26 09:54:59 

注册时间：

Date of Registration：

 2026-02-26 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

The efficacy of Tai Chi on the microbiome of patients with colorectal cancer: A pilot randomized controlled trial

Public title：

The efficacy of Tai Chi on the microbiome of patients with colorectal cancer: A pilot randomized controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

The efficacy of Tai Chi on the microbiome of patients with colorectal cancer: A pilot randomized controlled trial

Scientific title：

The efficacy of Tai Chi on the microbiome of patients with colorectal cancer: A pilot randomized controlled trial

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：

Lee Kang Qi Jessica 

研究负责人：

Takemura Naomi 

Applicant：

Lee Kang Qi Jessica 

Study leader：

Takemura Naomi 

申请注册联系人电话：

Applicant telephone：

 +852 5546 5842

研究负责人电话：

Study leader's
telephone：

+852 2766 4135

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：

 kang-qi-jessica.lee@polyu.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 naomi.takemura@polyu.edu.hk

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：

FG414a, The Hong Kong Polytechnic University Hung Hom, Kowloon, HKSAR

研究负责人通讯地址：

GH526, School of Nursing The Hong Kong Polytechnic University, Hung Hom, Kowloon, HKSAR

Applicant address：

FG414a, The Hong Kong Polytechnic University Hung Hom, Kowloon, HKSAR

Study leader's address：

GH526, School of Nursing The Hong Kong Polytechnic University, Hung Hom, Kowloon, HKSAR

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：

The Hong Kong Polytechnic University

Applicant's institution：

The Hong Kong Polytechnic University

研究负责人所在单位：

The Hong Kong Polytechnic University

Affiliation of the Leader：

The Hong Kong Polytechnic University

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：

 HSEARS20251230007

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：

PolyU Institutional Review Board

Name of the ethic committee：

PolyU Institutional Review Board

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-01-27 00:00:00

伦理委员会联系人：

YING Tin Cheung

Contact Name of the ethic committee：

YING Tin Cheung

伦理委员会联系地址：

Research and Innovation Office, Room GH252, GH Podium Annexe, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong

Contact Address of the ethic committee：

Research and Innovation Office, Room GH252, GH Podium Annexe, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 2766 5398

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：

The Hong Kong Polytechnic University

Primary sponsor：

The Hong Kong Polytechnic University

研究实施负责（组长）单位地址：

The Hong Kong Polytechnic University, Hung Hom, Kowloon, HKSAR

Primary sponsor's address：

The Hong Kong Polytechnic University, Hung Hom, Kowloon, HKSAR

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

The Hong Kong Polytechnic University

具体地址：

The Hong Kong Polytechnic University, Hung Hom, Kowloon, HKSAR

Institution
hospital：

The Hong Kong Polytechnic University

Address：

The Hong Kong Polytechnic University, Hung Hom, Kowloon, HKSAR

经费或物资来源：

Not applicable

Source(s) of funding：

Not applicable

研究疾病：

Colorectal cancer  

Target disease：

Colorectal cancer

研究疾病代码：

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：

The objective of this study is to examine the feasibility and preliminary efficacy of a 12-week Tai Chi intervention in improving gut microbiota diversity among patients with colorectal cancer at 12-week and 24-week follow-ups compared with a self-managed control group.  

Objectives of Study：

The objective of this study is to examine the feasibility and preliminary efficacy of a 12-week Tai Chi intervention in improving gut microbiota diversity among patients with colorectal cancer at 12-week and 24-week follow-ups compared with a self-managed control group.

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. Diagnosed with colorectal cancer confirmed by pathology, with no other cancer diagnosis within the previous year. 2. Karnofsky Performance Status (KPS) score >=70. 3. Aged 18 years or above. 4. Able to communicate in Cantonese or Mandarin. 5. Conscious and alert.

Inclusion criteria

1. Diagnosed with colorectal cancer confirmed by pathology, with no other cancer diagnosis within the previous year. 2. Karnofsky Performance Status (KPS) score >=70. 3. Aged 18 years or above. 4. Able to communicate in Cantonese or Mandarin. 5. Conscious and alert.

排除标准：

1. Somatic conditions that limit participation in exercise (e.g., limb loss, severe balance or postural instability, serious cardiopulmonary limitation, neurological or sensory deficits). 2. Current participation in any behavioral trial or instructor-led exercise program. 3. Regular practice of physical activity defined as >=150 minutes of moderate-intensity physical activity per week.

Exclusion criteria：

1. Somatic conditions that limit participation in exercise (e.g., limb loss, severe balance or postural instability, serious cardiopulmonary limitation, neurological or sensory deficits). 2. Current participation in any behavioral trial or instructor-led exercise program. 3. Regular practice of physical activity defined as >=150 minutes of moderate-intensity physical activity per week.

研究实施时间：

Study execute time：

从 From 2026-03-01 00:00:00至 To 2027-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-03-01 00:00:00 至 To 2027-12-31 00:00:00

干预措施：

Interventions：

组别：

Tai Chi intervention group

样本量：

 29

Group：

Tai Chi intervention group

Sample size：

干预措施：

16-form Yang-style Tai Chi program

干预措施代码：

Intervention：

16-form Yang-style Tai Chi program

Intervention code：

组别：

Self-managed control group

样本量：

 29

Group：

Self-managed control group

Sample size：

干预措施：

Self-managed physical activity (written ACSM exercise recommendation)

干预措施代码：

Intervention：

Self-managed physical activity (written ACSM exercise recommendation)

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong  

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 Queen Mary Hospital 

单位级别：

 Tertiary 

Institution
hospital：

Queen Mary Hospital

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

Gut microbiota diversity

指标类型：

次要指标

Outcome：

Gut microbiota diversity

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Physical function

指标类型：

次要指标

Outcome：

Physical 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：

Psychological distress

指标类型：

次要指标

Outcome：

Psychological distress

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Health-related quality of life

指标类型：

次要指标

Outcome：

Health-related quality of life

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：

Stool

组织：

Sample Name：

Stool

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

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）：

The random number sequence will be generated by an independent biostatistician using computer-generated block randomization with randomly varied block sizes between 6 and 12, stratified by primary cancer treatment (targeted therapy versus non-targeted therapy). The allocation sequence will be maintained by the biostatistician and will not be accessible to the research team members involved in participant recruitment or assessment to ensure allocation concealment.

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

The random number sequence will be generated by an independent biostatistician using computer-generated block randomization with randomly varied block sizes between 6 and 12, stratified by primary cancer treatment (targeted therapy versus non-targeted therapy). The allocation sequence will be maintained by the biostatistician and will not be accessible to the research team members involved in participant recruitment or assessment to ensure allocation concealment.

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：

All research team members, except for the research assistant responsible for informing participants of their group allocation, will be blinded to group assignment. Outcome assessments will be conducted by research assistants who are blinded to allocation. Tai Chi instructors will not be informed of the study design and will not be involved in outcome assessment. Due to the nature of the behavioral intervention, participants cannot be blinded.

Blinding：

All research team members, except for the research assistant responsible for informing participants of their group allocation, will be blinded to group assignment. Outcome assessments will be conducted by research assistants who are blinded to allocation. Tai Chi instructors will not be informed of the study design and will not be involved in outcome assessment. Due to the nature of the behavioral intervention, participants cannot be blinded.

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）：

The data will be available upon request after the study period.

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

The data will be available upon request after the study period.

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：

The study leader will be responsible for using a data management plan (DMP) to describe the use of data, and depositing a dataset in the Hong Kong Polytechnic University Scholars Hub.

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

The study leader will be responsible for using a data management plan (DMP) to describe the use of data, and depositing a dataset in the Hong Kong Polytechnic University Scholars Hub.

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：

  2026-02-26 09:54:59