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

Registration number：

ITMCTR2025000445

Date of Last Refreshed on：

2025-03-02

Date of Registration：

2025-03-02

Registration Status：

Prospective registration

Public title：

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

English Acronym：

Scientific title：

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

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Yu Pak Hung

Study leader：

Yu Pak Hung

Applicant telephone：

39435253

Study leader's telephone：

39435253

Applicant Fax：

Study leader's fax：

Applicant E-mail：

phayu@cuhk.edu.hk

Study leader's E-mail：

phayu@cuhk.edu.hk

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

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

Applicant postcode：

Study leader's postcode：

Applicant's institution：

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

Approved by ethic committee：

Approved No. of ethic committee：

2025.031-T

Approved file of Ethical Committee：

View

Name of the ethic committee：

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

Date of approved by ethic committee：

2025/2/14 0:00:00

Contact Name of the ethic committee：

Envy LEE

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

Contact phone of the ethic committee：

3505 3935

Contact email of the ethic committee：

crec@cuhk.edu.hk

Primary sponsor：

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

Primary sponsor's address：

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

Secondary sponsor：

Source(s) of funding：

NA

Target disease：

Chronic insomnia

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

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.

Description for medicine or protocol of treatment in detail：

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.

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.

Study execute time：

From 2025-03-13

To      2028-05-12

Recruiting time：

From 2025-03-13

To      2028-01-31

Interventions：

108

Group：

Waitlist Control Group

Sample size：

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：

108

Group：

Tai Chi Physical Movement Group

Sample size：

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：

108

Group：

Conventional Tai Chi Group

Sample size：

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：

Total sample size ： 324

Countries of recruitment
and research settings：

Country：

The People's Republic of China

Province：

Hong Kong Special Administrative Region

City：

Hong Kong

Institution/hospital：

The Chinese University of Hong Kong

Level of the institution：

University

Outcomes：

Outcome：

Resting-state Electroencephalography

Type：

Secondary indicator

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.

Outcome：

Sleep Medication Usage

Type：

Secondary indicator

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.

Outcome：

Patient Health Questionnaire-9 (PHQ9)

Type：

Secondary indicator

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.

Outcome：

7-day Actigraphy

Type：

Secondary indicator

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.

Outcome：

Remission of insomnia

Type：

Secondary indicator

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.

Outcome：

International Physical Activity Questionnaire Long Form (IPAQ-LC)

Type：

Secondary indicator

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

Outcome：

Pittsburgh Sleep Quality Index (PSQI)

Type：

Secondary indicator

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.

Outcome：

Cortisol Awakening Response (CAR)

Type：

Secondary indicator

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.

Outcome：

Insomnia Severity Index (ISI)

Type：

Primary indicator

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.

Outcome：

Generalized Anxiety Disorder 7-item scale (GAD7)

Type：

Secondary indicator

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.

Outcome：

7-day sleep diary

Type：

Secondary indicator

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.

Collecting sample(s)
from participants：

Sample Name：

Saliva

Tissue：

Fate of sample 

Preservation after use

Note：

5 years

Not yet recruiting

60
Min age years
100
Max age years

Recruiting status：

Participant age：

Gender：

Both

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.

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.

IPD sharing：

No

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

Not sharing IPD

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.

Data Managemen Committee：

Not yet

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

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