ElderlyMBTCCNCT05396092
The Effects of an Integrated Mindfulness-based Tai Chi Chuan Program on Sleep Disturbance Among Community-dwelling Elderly People
A study testing Integrated mindfulness-based Tai Chi Chuan, Mindfulness-based intervention and Tai Chi Chuan in people with Elderly and Sleep, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Elderly, Sleep, Mindfulness
- What is being tested?
- Integrated mindfulness-based Tai Chi Chuan, Mindfulness-based intervention and Tai Chi Chuan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteHong Kong
- Study dates
- 19 Apr 2022to 18 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Comorbid diagnoses of schizophrenia, schizoaffective disorder, substance misuse, organic brain syndrome, or intellectual disabilities.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Hong Kong Polytechnic University
Kowloon
Shu-Mei Wang, PhD, 852-27664197, shumei.wang@polyu.edu.hk
About this study
Official title: The Effects of an Integrated Mindfulness-based Tai Chi Chuan Program on Sleep Disturbance Among Community-dwelling Elderly People: A Randomized Controlled Trial
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.
- Conditions
- Elderly, Sleep, Mindfulness, Tai Chi Chuan
- Being tested
- Integrated mindfulness-based Tai Chi Chuan, Mindfulness-based intervention, Tai Chi Chuan, Sleep Hygiene Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated mindfulness-based Tai Chi ChuanBehavioural
Also called MBTCC
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.
Mindfulness-based interventionBehavioural
Also called MBI
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.
Tai Chi ChuanBehavioural
Also called TCC
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.
Sleep Hygiene EducationBehavioural
Also called SHE
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.
| Study group | Role | What they receive |
|---|---|---|
| Integrated mindfulness-based Tai Chi Chuan | Experimental | MBTCC Receives: Behavioral: Integrated mindfulness-based Tai Chi Chuan |
| Mindfulness-based intervention | Active comparator | MBI Receives: Behavioral: Mindfulness-based intervention |
| Tai Chi Chuan | Active comparator | TCC Receives: Behavioral: Tai Chi Chuan |
| Sleep Hygiene Education | Active comparator | SHE Receives: Behavioral: Sleep Hygiene Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Insomnia Severity Index
This is a seven-item self-report questionnaire. A higher score represents greater insomnia severity.
Measured: at baseline (T1)
the Insomnia Severity Index
This is a seven-item self-report questionnaire. A higher score represents greater insomnia severity.
Measured: In the 8th week from baseline (T2)
the Insomnia Severity Index
This is a seven-item self-report questionnaire. A higher score represents greater insomnia severity.
Measured: six months after T2 (T3)
the Insomnia Severity Index
This is a seven-item self-report questionnaire. A higher score represents greater insomnia severity.
Measured: one year after T2 (T4)
Secondary outcomes (8)
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.
Measured: at baseline (T1)
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.
Measured: In the 8th week from baseline (T2)
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.
Measured: six months after T2 (T3)
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.
Measured: one year after T2 (T4)
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.
Measured: at baseline (T1)
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.
Measured: In the 8th week from baseline (T2)
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.
Measured: six months after T2 (T3)
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.
Measured: one year after T2 (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start19 Apr 2022
- Primary completion18 Apr 2025 (estimated)
- Study completion18 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ElderlyStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Health Bureau, Hong Kong
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396092
- Sponsor's protocol ID
- HSEARS20210331002-01
- Acronym
- MBTCC
- Status last verified
- May 2022
- First submitted
- 17 May 2022
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of an Integrated Mindfulness-based Tai Chi Chuan Program on Sleep Disturbance Among Community-dwelling Elderly People: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05396092
- Acronym / sponsor ID
- MBTCC / HSEARS20210331002-01
- Conditions
- Elderly, Sleep, Mindfulness, Tai Chi Chuan
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Food and Health Bureau, Hong Kong
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 18 Apr 2025 (estimated)
- Study completion
- 18 Apr 2025 (estimated)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Integrated mindfulness-based Tai Chi Chuan | Experimental | Behavioral: Integrated mindfulness-based Tai Chi ChuanMBTCC |
| Mindfulness-based intervention | Active comparator | Behavioral: Mindfulness-based interventionMBI |
| Tai Chi Chuan | Active comparator | Behavioral: Tai Chi ChuanTCC |
| Sleep Hygiene Education | Active comparator | Behavioral: Sleep Hygiene EducationSHE |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (1 listed)
- Comorbid diagnoses of schizophrenia, schizoaffective disorder, substance misuse, organic brain syndrome, or intellectual disabilities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated mindfulness-based Tai Chi ChuanAlso: MBTCCMBTCC 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. | Behavioural | Integrated mindfulness-based Tai Chi Chuan |
| Mindfulness-based interventionAlso: MBIThe 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. | Behavioural | Mindfulness-based intervention |
| Tai Chi ChuanAlso: TCCTCC 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. | Behavioural | Tai Chi Chuan |
| Sleep Hygiene EducationAlso: SHESHE 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. | Behavioural | Sleep Hygiene Education |
Primary outcome
the Insomnia Severity Index
Time frame: at baseline (T1)
This is a seven-item self-report questionnaire. A higher score represents greater insomnia severity.
the Insomnia Severity Index
Time frame: In the 8th week from baseline (T2)
This is a seven-item self-report questionnaire. A higher score represents greater insomnia severity.
the Insomnia Severity Index
Time frame: six months after T2 (T3)
This is a seven-item self-report questionnaire. A higher score represents greater insomnia severity.
the Insomnia Severity Index
Time frame: one year after T2 (T4)
This is a seven-item self-report questionnaire. A higher score represents greater insomnia severity.
8 secondary outcomes
the Multidimensional Assessment of Interoceptive Awareness scale
Time frame: at baseline (T1)
the Multidimensional Assessment of Interoceptive Awareness scale
Time frame: In the 8th week from baseline (T2)
the Multidimensional Assessment of Interoceptive Awareness scale
Time frame: six months after T2 (T3)
the Multidimensional Assessment of Interoceptive Awareness scale
Time frame: one year after T2 (T4)
Wrist ActiGraph GT9X (ActiGraph, Pensacola, USA)
Time frame: at baseline (T1)
Wrist ActiGraph GT9X (ActiGraph, Pensacola, USA)
Time frame: In the 8th week from baseline (T2)
Wrist ActiGraph GT9X (ActiGraph, Pensacola, USA)
Time frame: six months after T2 (T3)
Wrist ActiGraph GT9X (ActiGraph, Pensacola, USA)
Time frame: one year after T2 (T4)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Derived from this study: PubMed 36153623Chan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated mindfulness-based Tai Chi Chuan, Mindfulness-based intervention and Tai Chi Chuan in people with Elderly and Sleep, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shu-Mei Wang, PhD (852-27664197, shumei.wang@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Insomnia Severity Index (time frame: at baseline (T1)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05396092, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.