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

May 24, 2022 updated by: The Hong Kong Polytechnic University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
256

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Kowloon, Hong Kong
        • Recruiting
        • Hong Kong Polytechnic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Integrated mindfulness-based Tai Chi Chuan
MBTCC
Behavioral: Integrated 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.
Other Names:
  • MBTCC
ACTIVE_COMPARATOR: Mindfulness-based intervention
MBI
Behavioral: Mindfulness-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.
Other Names:
  • MBI
ACTIVE_COMPARATOR: Tai Chi Chuan
TCC
Behavioral: Tai 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.
Other Names:
  • TCC
ACTIVE_COMPARATOR: Sleep Hygiene Education
SHE
Behavioral: Sleep 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.
Other Names:
  • SHE

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
the Insomnia Severity Index
Time Frame: at baseline (T1)
This is a seven-item self-report questionnaire. A higher score represents greater insomnia severity.
at baseline (T1)
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.
In the 8th week from baseline (T2)
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.
six months after T2 (T3)
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.
one year after T2 (T4)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
the Multidimensional Assessment of Interoceptive Awareness scale
Time Frame: at baseline (T1)
The scale consists of 32 items and comprises eight subscales. A higher score indicates higher levels of interoceptive awareness.
at baseline (T1)
the Multidimensional Assessment of Interoceptive Awareness scale
Time Frame: In the 8th week from baseline (T2)
The scale consists of 32 items and comprises eight subscales. A higher score indicates higher levels of interoceptive awareness.
In the 8th week from baseline (T2)
the Multidimensional Assessment of Interoceptive Awareness scale
Time Frame: six months after T2 (T3)
The scale consists of 32 items and comprises eight subscales. A higher score indicates higher levels of interoceptive awareness.
six months after T2 (T3)
the Multidimensional Assessment of Interoceptive Awareness scale
Time Frame: one year after T2 (T4)
The scale consists of 32 items and comprises eight subscales. A higher score indicates higher levels of interoceptive awareness.
one year after T2 (T4)
Wrist ActiGraph GT9X (ActiGraph, Pensacola, USA)
Time Frame: at baseline (T1)
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.
at baseline (T1)
Wrist ActiGraph GT9X (ActiGraph, Pensacola, USA)
Time Frame: In the 8th week from baseline (T2)
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.
In the 8th week from baseline (T2)
Wrist ActiGraph GT9X (ActiGraph, Pensacola, USA)
Time Frame: six months after T2 (T3)
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.
six months after T2 (T3)
Wrist ActiGraph GT9X (ActiGraph, Pensacola, USA)
Time Frame: one year after T2 (T4)
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.
one year after T2 (T4)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
the Chinese (Hong Kong) Short-Form-12
Time Frame: at baseline (T1)
A higher respective summary score indicates better levels of health.
at baseline (T1)
the Chinese (Hong Kong) Short-Form-12
Time Frame: In the 8th week from baseline (T2)
A higher respective summary score indicates better levels of health.
In the 8th week from baseline (T2)
the Chinese (Hong Kong) Short-Form-12
Time Frame: six months after T2 (T3)
A higher respective summary score indicates better levels of health.
six months after T2 (T3)
the Chinese (Hong Kong) Short-Form-12
Time Frame: one year after T2 (T4)
A higher respective summary score indicates better levels of health.
one year after T2 (T4)
the rumination subscale from the Rumination-Reflection Questionnaire
Time Frame: at baseline (T1)
A higher score suggests greater ruminative tendencies.
at baseline (T1)
the rumination subscale from the Rumination-Reflection Questionnaire
Time Frame: In the 8th week from baseline (T2)
A higher score suggests greater ruminative tendencies.
In the 8th week from baseline (T2)
the rumination subscale from the Rumination-Reflection Questionnaire
Time Frame: six months after T2 (T3)
A higher score suggests greater ruminative tendencies.
six months after T2 (T3)
the rumination subscale from the Rumination-Reflection Questionnaire
Time Frame: one year after T2 (T4)
A higher score suggests greater ruminative tendencies.
one year after T2 (T4)
the hyperarousal scale
Time Frame: at baseline (T1)
A higher score suggests a higher arousal level.
at baseline (T1)
the hyperarousal scale
Time Frame: In the 8th week from baseline (T2)
A higher score suggests a higher arousal level.
In the 8th week from baseline (T2)
the hyperarousal scale
Time Frame: six months after T2 (T3)
A higher score suggests a higher arousal level.
six months after T2 (T3)
the hyperarousal scale
Time Frame: one year after T2 (T4)
A higher score suggests a higher arousal level.
one year after T2 (T4)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Food and Health Bureau, Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 19, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 18, 2025

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 18, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 17, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 31, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 31, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSEARS20210331002-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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