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

NCT ID: NCT05396092

Last Updated: 2022-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-19

Study Completion Date

2025-04-18

Brief Summary

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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.

Detailed Description

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Conditions

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Elderly Sleep Mindfulness Tai Chi Chuan

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Integrated mindfulness-based Tai Chi Chuan

MBTCC

Group Type EXPERIMENTAL

Integrated mindfulness-based Tai Chi Chuan

Intervention Type BEHAVIORAL

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 intervention

MBI

Group Type ACTIVE_COMPARATOR

Mindfulness-based intervention

Intervention Type BEHAVIORAL

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 Chuan

TCC

Group Type ACTIVE_COMPARATOR

Tai Chi Chuan

Intervention Type BEHAVIORAL

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 Education

SHE

Group Type ACTIVE_COMPARATOR

Sleep Hygiene Education

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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MBTCC MBI TCC SHE

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Food and Health Bureau, Hong Kong

OTHER_GOV

Sponsor Role collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hong Kong Polytechnic University

Kowloon, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Shu-Mei Wang, PhD

Role: CONTACT

Phone: 852-27664197

Email: [email protected]

Facility Contacts

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Shu-Mei Wang, PhD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 36153623 (View on PubMed)

Other Identifiers

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HSEARS20210331002-01

Identifier Type: -

Identifier Source: org_study_id