CClinicalTrials.gg
Sign In
RecruitingNCT05396092MBTCCUpdated May 31, 2022

The Effects of an Integrated Mindfulness-based Tai Chi Chuan Program on Sleep Disturbance Among Community-dwelling Elderly People

An interventional study of Integrated mindfulness-based Tai Chi Chuan and Mindfulness-based intervention in Elderly, Sleep and Mindfulness, sponsored by The Hong Kong Polytechnic University. Recruiting at 1 site in Hong Kong. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2022-05-31.

Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 5 months ago, but the record still lists the study as recruiting.
  • Started Apr 2022; still recruiting 4 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
256
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study summary

The trial aims to evaluate the effects of an integrated form of mindfulness-based Tai Chi Chuan (MBTCC) program and the underlying mechanisms of the beneficial effects on sleep disturbance over 12-month follow-up in community-dwelling elderly people.

02

Conditions studied

  • Elderly
  • Sleep
  • Mindfulness
  • Tai Chi Chuan
03

In context

Dyssomnias

324 studies on the registry are indexed under Dyssomnias; 51 are open to participants now.

This study's planned enrollment of 256 is above the median of 60 across 251 interventional studies indexed under Dyssomnias.

Browse Dyssomnias studies →

Lead sponsor

The Hong Kong Polytechnic University is the lead sponsor of 659 studies on the registry; 250 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Aged 60 years or above;
  • Classified as experiencing sleep disturbances (indication of poor sleep quality through a score >5 in the Pittsburgh Sleep Quality Index);
  • Primary education level or above and able to communicate in Cantonese;
  • Able to give informed consent; and
  • No previous experience with meditation or other mind-body techniques (e.g., tai chi or yoga).

Exclusion criteria

Exclusion criteria:

  • Comorbid diagnoses of schizophrenia, schizoaffective disorder, substance misuse, organic brain syndrome, or intellectual disabilities.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
256 participants (estimated)

Study arms

  • Experimental
    Integrated mindfulness-based Tai Chi Chuan

    MBTCC

    Behavioral: Integrated mindfulness-based Tai Chi Chuan

  • Active comparator
    Mindfulness-based intervention

    MBI

    Behavioral: Mindfulness-based intervention

  • Active comparator
    Tai Chi Chuan

    TCC

    Behavioral: Tai Chi Chuan

  • Active comparator
    Sleep Hygiene Education

    SHE

    Behavioral: Sleep Hygiene Education

Interventions

  • BehavioralIntegrated mindfulness-based Tai Chi Chuan

    MBTCC will integrate components from both the MBI and TCC groups. The entire intervention consists of eight weekly sessions of two-and-a-half to three hours each.

    Also known as: MBTCC

  • BehavioralMindfulness-based intervention

    The MBI group is mainly based on the basic theory and research of the foundational mindfulness-based stress reduction program. The intervention consists of eight weekly sessions of two to two-and-a-half hours each.

    Also known as: MBI

  • BehavioralTai Chi Chuan

    TCC is mainly based on a nine-form Yang-style form of TCC, which is a brief and modified version of 64-form Yang-style TCC. The entire intervention consists of eight weekly sessions of two to two-and-a-half hours each.

    Also known as: TCC

  • BehavioralSleep Hygiene Education

    SHE is based on principles used in stimulus control and sleep hygiene education, which has previously been used as the control group in sleep-related research. The entire intervention consists of eight weekly sessions of two to two-and-a-half hours each.

    Also known as: SHE

06

What researchers measure

Primary outcomes

  1. the Insomnia Severity Index

    This is a seven-item self-report questionnaire. A higher score represents greater insomnia severity.

    Time frame: at baseline (T1)

  2. the Insomnia Severity Index

    This is a seven-item self-report questionnaire. A higher score represents greater insomnia severity.

    Time frame: In the 8th week from baseline (T2)

  3. the Insomnia Severity Index

    This is a seven-item self-report questionnaire. A higher score represents greater insomnia severity.

    Time frame: six months after T2 (T3)

  4. the Insomnia Severity Index

    This is a seven-item self-report questionnaire. A higher score represents greater insomnia severity.

    Time frame: one year after T2 (T4)

Secondary outcomes

  1. the Multidimensional Assessment of Interoceptive Awareness scale

    The scale consists of 32 items and comprises eight subscales. A higher score indicates higher levels of interoceptive awareness.

    Time frame: at baseline (T1)

  2. the Multidimensional Assessment of Interoceptive Awareness scale

    The scale consists of 32 items and comprises eight subscales. A higher score indicates higher levels of interoceptive awareness.

    Time frame: In the 8th week from baseline (T2)

  3. the Multidimensional Assessment of Interoceptive Awareness scale

    The scale consists of 32 items and comprises eight subscales. A higher score indicates higher levels of interoceptive awareness.

    Time frame: six months after T2 (T3)

  4. the Multidimensional Assessment of Interoceptive Awareness scale

    The scale consists of 32 items and comprises eight subscales. A higher score indicates higher levels of interoceptive awareness.

    Time frame: one year after T2 (T4)

  5. Wrist ActiGraph GT9X (ActiGraph, Pensacola, USA)

    Participants will be asked to put on this ActiGraph GT9X (like a watch) on the wrist of the non-dominant hand for one week. Wrist ActiGraph GT9X is used to assess the average total sleep time (hours) per night.

    Time frame: at baseline (T1)

  6. Wrist ActiGraph GT9X (ActiGraph, Pensacola, USA)

    Participants will be asked to put on this ActiGraph GT9X (like a watch) on the wrist of the non-dominant hand for one week. Wrist ActiGraph GT9X is used to assess the average total sleep time (hours) per night.

    Time frame: In the 8th week from baseline (T2)

  7. Wrist ActiGraph GT9X (ActiGraph, Pensacola, USA)

    Participants will be asked to put on this ActiGraph GT9X (like a watch) on the wrist of the non-dominant hand for one week. Wrist ActiGraph GT9X is used to assess the average total sleep time (hours) per night.

    Time frame: six months after T2 (T3)

  8. Wrist ActiGraph GT9X (ActiGraph, Pensacola, USA)

    Participants will be asked to put on this ActiGraph GT9X (like a watch) on the wrist of the non-dominant hand for one week. Wrist ActiGraph GT9X is used to assess the average total sleep time (hours) per night.

    Time frame: one year after T2 (T4)

Other outcomes

  1. the Chinese (Hong Kong) Short-Form-12

    A higher respective summary score indicates better levels of health.

    Time frame: at baseline (T1)

  2. the Chinese (Hong Kong) Short-Form-12

    A higher respective summary score indicates better levels of health.

    Time frame: In the 8th week from baseline (T2)

  3. the Chinese (Hong Kong) Short-Form-12

    A higher respective summary score indicates better levels of health.

    Time frame: six months after T2 (T3)

  4. the Chinese (Hong Kong) Short-Form-12

    A higher respective summary score indicates better levels of health.

    Time frame: one year after T2 (T4)

  5. the rumination subscale from the Rumination-Reflection Questionnaire

    A higher score suggests greater ruminative tendencies.

    Time frame: at baseline (T1)

  6. the rumination subscale from the Rumination-Reflection Questionnaire

    A higher score suggests greater ruminative tendencies.

    Time frame: In the 8th week from baseline (T2)

  7. the rumination subscale from the Rumination-Reflection Questionnaire

    A higher score suggests greater ruminative tendencies.

    Time frame: six months after T2 (T3)

  8. the rumination subscale from the Rumination-Reflection Questionnaire

    A higher score suggests greater ruminative tendencies.

    Time frame: one year after T2 (T4)

  9. the hyperarousal scale

    A higher score suggests a higher arousal level.

    Time frame: at baseline (T1)

  10. the hyperarousal scale

    A higher score suggests a higher arousal level.

    Time frame: In the 8th week from baseline (T2)

  11. the hyperarousal scale

    A higher score suggests a higher arousal level.

    Time frame: six months after T2 (T3)

  12. the hyperarousal scale

    A higher score suggests a higher arousal level.

    Time frame: one year after T2 (T4)

07

Study locations

1 of 1 sites recruiting
  • Hong Kong Polytechnic University
    Kowloon, Hong Kong
    Recruiting
08

References and documents

Publications

  • Chan SH, Ng SM, Yu CH, Chan CM, Wang SM, Chan WC. The effects of an integrated mindfulness-based tai chi chuan programme on sleep disturbance among community-dwelling elderly people: protocol for a randomized controlled trial. Trials. 2022 Sep 24;23(1):808. doi: 10.1186/s13063-022-06737-4. PubMed 36153623 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05396092
Lead sponsor
The Hong Kong Polytechnic University
Collaborators
Food and Health Bureau, Hong Kong
Responsible party
Sponsor
First posted
May 31, 2022
Start date
Apr 19, 2022
Primary completion
Apr 18, 2025 (estimated)
Completion
Apr 18, 2025 (estimated)
Last update
May 31, 2022

Study contacts

Shu-Mei Wang, PhD
Contact
shumei.wang@polyu.edu.hk
852-27664197

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Dyssomnias→

Other studies from this sponsor

The Hong Kong Polytechnic University

Start the discussion