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注册号：

Registration number：

ITMCTR2025000445

最近更新日期：

Date of Last Refreshed on：

2025-03-02

注册时间：

Date of Registration：

2025-03-02

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

Public title：

Decipher the respective effects of the physical exercise element and meditation element of Tai Chi in alleviating insomnia. A randomized controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Scientific title：

Decipher the respective effects of the physical exercise element and meditation element of Tai Chi in alleviating insomnia. A randomized controlled trial

研究课题的正式科学名称简写：

Scientific title acronym：

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：

研究负责人：

Applicant：

Yu Pak Hung

Study leader：

Yu Pak Hung

申请注册联系人电话：

Applicant telephone：

39435253

研究负责人电话：

Study leader's telephone：

39435253

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：

phayu@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

phayu@cuhk.edu.hk

申请单位网址(自愿提供)：

Study leader's 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：

研究负责人通讯地址：

Applicant address：

G02; Kwok Sports Building; University Ave; The Chinese University of Hong Kong; Shatin; Hong Kong

Study leader's address：

G02; Kwok Sports Building; University Ave; The Chinese University of Hong Kong; Shatin; 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：

Applicant's institution：

Department of Sports Science and Physical Education; The Chinese University of Hong Kong

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

2025.031-T

伦理委员会批件附件：

Approved file of Ethical Committee：

查看附件

批准本研究的伦理委员会名称：

Name of the ethic committee：

Joint Chinese University of Hong Kong (CUHK) and New Territories East Cluster (NTEC) Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2025/2/14 0:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

Envy LEE

伦理委员会联系地址：

Contact Address of the ethic committee：

Joint CUHK-NTEC Clinical Research Ethics Committee; 8/F Lui Che Woo Clinical Sciences Building; Prince of Wales Hospital; Shatin; Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

3505 3935

伦理委员会联系人邮箱：

Contact email of the ethic committee：

crec@cuhk.edu.hk

研究实施负责（组长）单位：

Primary sponsor：

Department of Sports Science and Physical Education; The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

Primary sponsor's address：

G02; Kwok Sports Building; University Ave; The Chinese University of Hong Kong; Shatin; Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Source(s) of funding：

NA

研究疾病：

研究疾病代码：

Target disease：

Chronic insomnia

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段：

Study phase：

其它

Others

研究目的：

Objectives of Study：

This study aims to investigate the effects of the physical exercise and meditation elements of Tai Chi on improving sleep in older adults with chronic insomnia.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

Be 60 years or older; Ethnic Chinese; Tai Chi naive; Fulfill the criteria of chronic insomnia defined in Diagnostic and Statistical Manual of Mental Disorders Fifth Edition Text Revision (DSM-5-TR) which are: 1) manifestation of predominant subpar sleep quantity or quality; 2) exhibition of any sleep difficulties ranging from sleep initiation sleep maintenance to early awakening with the inability to restore sleep. 3) concomitant presentation of significant distress or impairment including fatigue or low energy cognitive impairment mood disturbance behavioral problems impaired occupational or academic functioning impaired interpersonal or social functioning and negative impact on caregiver or family functioning; 4) sleep difficulty occurs at least three nights per week; 5) sleep difficulty has been persistent for at least three months; and 6) sleep difficulty is not affected regardless of adequate opportunity given for sleep.

排除标准：

Exclusion criteria：

Pre-existing health conditions preventing participation in Tai Chi training; Currently receiving cognitive behavioral therapy of insomnia; Regular exercise habits (>3 times of 60-min moderate intensity exercise per week) in the past 3 months; Regular meditation habits (>3 times per week) in the last three months.

研究实施时间：

Study execute time：

从From 2025-03-13

至To      2028-05-12

征募观察对象时间：

Recruiting time：

从From 2025-03-13

至To      2028-01-31

干预措施：

Interventions：

组别：

样本量：

108

Group：

Waitlist Control Group

Sample size：

干预措施：

干预措施代码：

Intervention：

Participants in the waitlist control group will not receive any interventions in addition to the usual care they are receiving during the intervention period.

Intervention code：

组别：

样本量：

108

Group：

Tai Chi Physical Movement Group

Sample size：

干预措施：

干预措施代码：

Intervention：

Participants allocated to the Tai Chi physical movement group will undergo a Tai Chi physical movement training consisting of two 90-minute sessions per week for 12 weeks. The instructors will omit the meditation element and only teach the physical movements of the Yang style 24-form simplified Tai Chi. Participants will be instructed to refrain from reading any Tai Chi-related materials over the course of study.

Intervention code：

组别：

样本量：

108

Group：

Conventional Tai Chi Group

Sample size：

干预措施：

干预措施代码：

Intervention：

Participants will receive a conventional Tai Chi intervention consisting of two 90-minute sessions per week for 12 weeks. During the first half of each training session participants will learn the physical movement of Tai Chi. Meditation instructions to the respective Tai Chi movements will be introduced in the second half of the session during which the participants will practice the movements with the meditation element.

Intervention code：

样本总量 Total sample size ： 324

研究实施地点：

Countries of recruitment
and research settings：

国家：

省(直辖市)：

市(区县)：

Country：

The People's Republic of China

Province：

Hong Kong Special Administrative Region

City：

Hong Kong

单位(医院)：

单位级别：

Institution/hospital：

The Chinese University of Hong Kong

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

指标类型：

次要指标

Outcome：

Resting-state Electroencephalography

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Week 6 (Post-intervention)

Measure method：

Participants will be instructed to sit comfortably with minimal movement in a quiet environment. Resting brain activity will be recorded under an eye-closed condition for 5 minutes, followed by an eyes-open condition for 5 minutes, using a 64-probe electroencephalography. The spectral powers of delta band; theta band; alpha band; beta band; and gamma band will be determined.

指标中文名：

指标类型：

主要指标

Outcome：

Insomnia Severity Index (ISI)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Week 6 (Post-intervention)

Measure method：

A semi-structured interview will be conducted to assess the perceived insomnia severity using ISI. ISI is a a commonly used instrument in clinical settings that consists of seven items to evaluate sleep onset sleep maintenance early awakening satisfaction with the current sleep pattern impairment of daily functioning due to sleep noticeable impairment due to sleep problems degree of distress and concerns caused by sleep problems.

指标中文名：

指标类型：

次要指标

Outcome：

7-day sleep diary

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Week 6 (Post-intervention)

Measure method：

Participants will be instructed to record their sleep pattern including on-bed time leave bed time total sleep time and the number of awakenings for 7 days on a sleep diary while wearing the actigraph device. The 7-day average of subjective sleep parameters (i.e. sleep onset latency total sleep time wake time after sleep onset sleep efficiency number of awakenings and average awaken time) will be estimated by the sleep diary record.

指标中文名：

指标类型：

次要指标

Outcome：

Remission of insomnia

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Week 6 (Post-intervention)

Measure method：

A semi-structured interview will be conducted to assess sleep based on the established criteria defined by Diagnostic and Statistical Manual of Mental Disorders Fifth Edition Text Revision (DSM-5-TR) . A Remission of insomnia is deemed when a participant no longer meets the criteria.

指标中文名：

指标类型：

次要指标

Outcome：

Cortisol Awakening Response (CAR)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Week 6 (Post-intervention)

Measure method：

The arousal level will be assessed by CAR which is widely used in sleep research. Saliva samples will be collected immediately after awakening; 30 minutes after awakening; 60 minutes after awakening; 90 minutes after awakening; noon; 4:00p.m.; and right before sleep. The saliva cortisol levels will be measured to determine CAR.

指标中文名：

指标类型：

次要指标

Outcome：

Generalized Anxiety Disorder 7-item scale (GAD7)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Week 6 (Post-intervention)

Measure method：

A semi-structured interview will be conducted to assess the severity of of anxiety symptoms using GAD7. It consists of seven items and the overall score ranges from 0 to 21 with higher scores indicating more severe anxiety symptoms.

指标中文名：

指标类型：

次要指标

Outcome：

Sleep Medication Usage

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Week 6 (Post-intervention)

Measure method：

Participants will be instructed to record the dose and frequency associated with the use of any medications in the 7-day sleep diary. Data on medication dose and weekly frequency will be presented as the total number of the lowest recommended dose (LRD) in 7 days.

指标中文名：

指标类型：

次要指标

Outcome：

Patient Health Questionnaire-9 (PHQ9)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Week 6 (Post-intervention)

Measure method：

A semi-structured interview will be conducted to assess the severity of depressive symptoms using PHQ9. There are nine items and the total score ranges from 0 to 27 with higher scores suggesting higher depressive symptom severity.

指标中文名：

指标类型：

次要指标

Outcome：

International Physical Activity Questionnaire Long Form (IPAQ-LC)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Week 6 (Post-intervention)

Measure method：

A semi-structured interview will be conducted to assess the habitual activity levels of the participants using IPAQ-LC

指标中文名：

指标类型：

次要指标

Outcome：

Pittsburgh Sleep Quality Index (PSQI)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Week 6 (Post-intervention)

Measure method：

A semi-structured interview will be conducted to assess the subjective sleep quality using the PSQI. The PSQI assesses 7 components of subjective sleep quality including self-reported sleep quantity use of sleep medication and disturbances of sleep and is considered one of the most frequently used assessments of subjective sleep quality.

指标中文名：

指标类型：

次要指标

Outcome：

7-day Actigraphy

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Week 6 (Post-intervention)

Measure method：

Participants will be instructed to wear a wrist actigraph device on their non-dominant wrists 24 hours for 7 days to measure objective sleep. The 7-day average of objective sleep parameters (i.e. sleep onset latency total sleep time wake time after sleep onset sleep efficiency number of awakening and average awaken time) will be estimated by the data in the actigraphy record.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

组织：

Sample Name：

Saliva

Tissue：

人体标本去向

使用后保存

说明

Fate of sample 

Preservation after use

Note：

5 years

征募研究对象情况：

尚未开始

Not yet recruiting

年龄范围：

最小 60 岁
Min age years
最大 100 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

男女均可

Both

随机方法（请说明由何人用什么方法产生随机序列）：

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

A computer-generated randomized allocation sequence will be produced using random block sizes of of 3 or 6 or 12. Participants will be randomly allocated to the Conventional Tai Chi; Tai Chi physical movement; and Waitlist control groups on a 1:1:1 basis.

盲法：

Blinding：

Due to the nature of the interventions the control and the two Tai Chi intervention groups will not be blinded to group allocation. Although the instructors cannot be blinded due to their involvement in delivering the training sessions the outcome assessments will be performed by research personnel who will be completely blinded to the group allocation. Participants will be instructed to refrain from disclosing their group allocation to the assessors.

是否共享原始数据：

IPD sharing：

否

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）：

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

Not sharing IPD

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：

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

The personal information and identity of participants will be strictly protected. Each participant will be assigned a unique study number for anonymous data collection. All the study data will be stored separately from the participants identity and personal information on encrypted hard disks kept in a locked cabinet. Only the research personnel of this project will have access to the locked cabinet and the hard disk encryption. The personal data will be kept 5 years after the study and then it will be discarded permanently.

数据管理委员会：

Data Managemen Committee：

暂未确定

Not yet

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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