ChiCTR2400087923 版本V1.0 版本创建时间2024/08/07 11:35:10 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：

 ChiCTR2400087923 

最近更新日期：

Date of Last Refreshed on：

 2024-08-07 11:34:52 

注册时间：

Date of Registration：

 2024-08-07 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

The efficacy of an online exercise intervention for improving depressive symptoms among patients with subthreshold depression in primary care: a randomized controlled trial

Public title：

The efficacy of an online exercise intervention for improving depressive symptoms among patients with subthreshold depression in primary care: a 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 an online exercise intervention for improving depressive symptoms among patients with subthreshold depression in primary care: a randomized controlled trial

Scientific title：

The efficacy of an online exercise intervention for improving depressive symptoms among patients with subthreshold depression in primary care: a 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：

NGAI CHUN HO 

研究负责人：

Samuel Yeung-shan WONG 

Applicant：

NGAI CHUN HO 

Study leader：

Samuel Yeung-shan WONG 

申请注册联系人电话：

Applicant telephone：

 +852 2252 8463

研究负责人电话：

Study leader's
telephone：

+852 2252 8774

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：

 alfonsengai@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 yeungshanwong@cuhk.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：

Room 426, School of Public Health Building, Prince of Wales Hospital, Shatin, New Territories, Hong

研究负责人通讯地址：

2/F, School of Public Health Building, Prince of Wales Hospital, Shatin, New Territories, Hong Kong

Applicant address：

Room 426, School of Public Health Building, Prince of Wales Hospital, Shatin, New Territories, Hong Kong

Study leader's address：

2/F, School of Public Health Building, Prince of Wales Hospital, Shatin, New Territories, Hong Kong

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：

JC School of Public Health and Primary Care, Chinese University of Hong Kong

Applicant's institution：

JC School of Public Health and Primary Care, Chinese University of Hong Kong

研究负责人所在单位：

JC School of Public Health and Primary Care, Chinese University of Hong Kong

Affiliation of the Leader：

JC School of Public Health and Primary Care, Prince of Wales Hospital, Chinese University of Hong Kong

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：

 2023.321-T

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：

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee

Name of the ethic committee：

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-08-04 00:00:00

伦理委员会联系人：

Envy Lee

Contact Name of the ethic committee：

Envy Lee

伦理委员会联系地址：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, 30-32 Yincheng Street, Shatin, Hong Kong

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, 30-32 Yincheng Street, Shatin, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3505 3935

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：

Joint Chinese University of Hong Kong

Primary sponsor：

Joint Chinese University of Hong Kong

研究实施负责（组长）单位地址：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, 30-32 Yincheng Street, Shatin, Hong Kong

Primary sponsor's address：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, 30-32 Yincheng Street, Shatin, Hong Kong

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)：

Health Bureau

具体地址：

9/F, Rumsey Street Multi-storey Carpark Building 2 Rumsey Street, Sheung Wan Hong Kong

Institution
hospital：

Health Bureau

Address：

9/F, Rumsey Street Multi-storey Carpark Building 2 Rumsey Street, Sheung Wan Hong Kong

经费或物资来源：

Health Services Research Fund

Source(s) of funding：

Health Services Research Fund

研究疾病：

Subthreshold depression  

Target disease：

Subthreshold depression

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：

 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：

1. Examine the effectiveness of a 12-week online instructor-led exercise intervention (EIM) when compared to usual care control in reducing depressive symptoms among people with subthreshold depression in primary care 2. Examine the effectiveness of a 12-week online instructor-led exercise intervention (EIM) when compared to usual care control in reducing anxiety symptoms and improving quality of life among people with subthreshold depression in primary care  

Objectives of Study：

1. Examine the effectiveness of a 12-week online instructor-led exercise intervention (EIM) when compared to usual care control in reducing depressive symptoms among people with subthreshold depression in primary care 2. Examine the effectiveness of a 12-week online instructor-led exercise intervention (EIM) when compared to usual care control in reducing anxiety symptoms and improving quality of life among people with subthreshold depression in primary care

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

The inclusion criteria for this study are 1) aged 18 years or above; 2) screened by the Patient Health Questionnaire depression scale (PHQ-9) with results categorized as subthreshold depression, major depression or no depression.

Inclusion criteria

The inclusion criteria for this study are 1) aged 18 years or above; 2) screened by the Patient Health Questionnaire depression scale (PHQ-9) with results categorized as subthreshold depression, major depression or no depression.

排除标准：

The exclusion criteria are 1) dysthymia with subthreshold depressive symptoms that last for 2 years or more; 2) major depression within the past 6 months, lifetime history of psychosis, schizophrenia and bipolar affective disorder, alcohol or substance abuse, presence of serious suicidal risk and medical illness with a prognosis of less than 6 months to live; 3) patients who are taking antidepressants need to be taking the same medications for more than 3 months with good compliance to be eligible to enroll. 4) patients currently enrolled in any form of psychological interventions for any depressive disorders or symptoms and 5) the presence of physical conditions and include the presence of recently diagnosed or uncontrolled cardiovascular diseases or uncontrolled hypertension, metabolic, vascular or neurological conditions.

Exclusion criteria：

The exclusion criteria are 1) dysthymia with subthreshold depressive symptoms that last for 2 years or more; 2) major depression within the past 6 months, lifetime history of psychosis, schizophrenia and bipolar affective disorder, alcohol or substance abuse, presence of serious suicidal risk and medical illness with a prognosis of less than 6 months to live; 3) patients who are taking antidepressants need to be taking the same medications for more than 3 months with good compliance to be eligible to enroll. 4) patients currently enrolled in any form of psychological interventions for any depressive disorders or symptoms and 5) the presence of physical conditions and include the presence of recently diagnosed or uncontrolled cardiovascular diseases or uncontrolled hypertension, metabolic, vascular or neurological conditions.

研究实施时间：

Study execute time：

从 From 2024-07-01 00:00:00至 To 2027-07-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-08-12 00:00:00 至 To 2026-12-31 00:00:00

干预措施：

Interventions：

组别：

"Exercise is Medicine" (EIM) program

样本量：

 130

Group：

"Exercise is Medicine" (EIM) program

Sample size：

干预措施：

12-week EIM class

干预措施代码：

Intervention：

12-week EIM class

Intervention code：

组别：

Control Group

样本量：

 130

Group：

Control Group

Sample size：

干预措施：

Usual care

干预措施代码：

Intervention：

Usual care

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)：

 New Territories East Cluster  

单位级别：

 General Outpatient Clinics (GOPCs) and Family Medicine Clinics  

Institution
hospital：

New Territories East Cluster

Level of the institution：

General Outpatient Clinics (GOPCs) and Family Medicine Clinics

测量指标：

Outcomes：

指标中文名：

Depressive Symptoms

指标类型：

主要指标

Outcome：

Depressive Symptoms

Type：

Primary indicator

测量时间点：

测量方法：

Chinese version Beck Depression Inventory-II (BDI-II)

Measure time point of outcome：

Measure method：

Chinese version Beck Depression Inventory-II (BDI-II)

指标中文名：

Anxiety Symptoms

指标类型：

次要指标

Outcome：

Anxiety Symptoms

Type：

Secondary indicator

测量时间点：

测量方法：

Beck Anxiety Inventory

Measure time point of outcome：

Measure method：

Beck Anxiety Inventory

指标中文名：

Quality of Life

指标类型：

次要指标

Outcome：

Quality of Life

Type：

Secondary indicator

测量时间点：

测量方法：

Chinese version Medical Outcomes Study Short-Form Health Survey (SF-12)

Measure time point of outcome：

Measure method：

Chinese version Medical Outcomes Study Short-Form Health Survey (SF-12)

指标中文名：

Physical activity levels

指标类型：

次要指标

Outcome：

Physical activity levels

Type：

Secondary indicator

测量时间点：

测量方法：

international Physical Activity Questionnaire – short form (IPAQ-SF)

Measure time point of outcome：

Measure method：

international Physical Activity Questionnaire – short form (IPAQ-SF)

指标中文名：

Medication use and health service utilization

指标类型：

次要指标

Outcome：

Medication use and health service utilization

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：

NA

组织：

Sample Name：

NA

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）：

Stratified block randomization with random block sizes will be used to enhance balance of gender, anxiety symptoms and level of physical activity at baseline between two arms. The randomisation sequence will be generated by an experienced independent statistician using Random Allocation Software. The sealed randomization code will be stored safely and will be inaccessible to any person involved in the study. The randomization number will not be decoded until the participant is assigned to its corresponding randomization number.

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

Stratified block randomization with random block sizes will be used to enhance balance of gender, anxiety symptoms and level of physical activity at baseline between two arms. The randomisation sequence will be generated by an experienced independent statistician using Random Allocation Software. The sealed randomization code will be stored safely and will be inaccessible to any person involved in the study. The randomization number will not be decoded until the participant is assigned to its corresponding randomization number.

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：

The allocation is concealed from the researchers, research assistants or coordinators who carry out the baseline assessment or recorded the data, and the statistician who carries out the analysis.

Blinding：

The allocation is concealed from the researchers, research assistants or coordinators who carry out the baseline assessment or recorded the data, and the statistician who carries out the analysis.

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）：

Available upon request after trial completion

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

Available upon request after trial completion

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：

NA

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

NA

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：

  2024-08-07 11:34:52