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

NCT05396092 | Unknown

• 1 other identifier: HSEARS20210331002-01
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Elderly; Sleep; Mindfulness; Tai Chi Chuan

Outcome Measures

Primary Outcomes (4)

• the Insomnia Severity Index

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

  at baseline (T1)

• the Insomnia Severity Index

  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

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

  six months after T2 (T3)

• the Insomnia Severity Index

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

  one year after T2 (T4)

Secondary Outcomes (8)

• the Multidimensional Assessment of Interoceptive Awareness scale

  at baseline (T1)

• the Multidimensional Assessment of Interoceptive Awareness scale

  In the 8th week from baseline (T2)

• the Multidimensional Assessment of Interoceptive Awareness scale

  six months after T2 (T3)

• the Multidimensional Assessment of Interoceptive Awareness scale

  one year after T2 (T4)

• Wrist ActiGraph GT9X (ActiGraph, Pensacola, USA)

  at baseline (T1)

Other Outcomes (12)

• the Chinese (Hong Kong) Short-Form-12

  at baseline (T1)

• the Chinese (Hong Kong) Short-Form-12

  In the 8th week from baseline (T2)

• the Chinese (Hong Kong) Short-Form-12

  six months after T2 (T3)

Study Arms (4)

Integrated mindfulness-based Tai Chi Chuan

EXPERIMENTAL

MBTCC

Behavioral: Integrated mindfulness-based Tai Chi Chuan

Mindfulness-based intervention

ACTIVE COMPARATOR

MBI

Behavioral: Mindfulness-based intervention

Tai Chi Chuan

ACTIVE COMPARATOR

TCC

Behavioral: Tai Chi Chuan

Sleep Hygiene Education

ACTIVE COMPARATOR

SHE

Behavioral: Sleep Hygiene Education

Interventions

Integrated mindfulness-based Tai Chi Chuan 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.

Also known as: MBTCC

Integrated mindfulness-based Tai Chi Chuan

Mindfulness-based intervention 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.

Also known as: MBI

Mindfulness-based intervention

Tai Chi Chuan 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.

Also known as: TCC

Tai Chi Chuan

Sleep Hygiene Education 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.

Also known as: SHE

Sleep Hygiene Education

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Food and Health Bureau, Hong Kong: collaborator

Study Sites (1)

Hong Kong Polytechnic University

Kowloon, Hong Kong

RECRUITING

Related Publications (1)

• 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.

  PMID: 36153623 DERIVED

MeSH Terms

Interventions

Tai Ji

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Central Study Contacts

Shu-Mei Wang, PhD

CONTACT

852-27664197; shumei.wang@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 31, 2022
• Study Start: April 19, 2022
• Primary Completion: April 18, 2025
• Study Completion: April 18, 2025
• Last Updated: May 31, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)