NCT03404765

Brief Summary

The prevalence of older people with cognitive decline is increasing since the aging population is growing substantially worldwide. Cognitive impairment places older adults at high risk for functional disability. Previous researches have provided strong evidence on the beneficial effects of physical exercise on maintaining cognitive functions in older adults. Tai Chi is considered as a low to moderate intensity exercise, which is performed in a slow and rhythmic movement. It is a popular and safe exercise suitable for older people who have weaker muscle strength. The aim of this study was to determine the effects of Tai Chi on cognition and instrumental activities of daily living (I-ADLs), and health-related quality of life (HRQOL) in older Chinese adults with mild cognitive impairment (MCI). The research hypothesis of the study stated: There is significant improvement in the general cognitive performance, functional capabilities of instrumental ADLs,the physical component and mental component of HRQOL between the group of community-dwelling older people with MCI who have participated and the control group who have not participated in the Tai Chi program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 19, 2018

Completed
Last Updated

January 19, 2018

Status Verified

January 1, 2018

Enrollment Period

9 months

First QC Date

January 8, 2018

Last Update Submit

January 12, 2018

Conditions

Keywords

Tai ChiCognitionInstrumental activities of daily livingHealth-related Quality of Life

Outcome Measures

Primary Outcomes (1)

  • Change from baseline C-MMSE score at four months

    The Chinese version of Mini-Mental State Examination (C-MMSE) is a global cognitive assessment tool.The first part of the CMMSE assesses respondent's abilities on orientation, memory and attention and the second part tests respondent's ability to name objects, understanding on verbal and written commands; higher score indicates for better cognitive performance.

    he outcome assessment was conducted at baseline, and at 4 month (at the end of study)

Secondary Outcomes (2)

  • Change from baseline IADL-CV score at four months

    The outcome assessment was conducted at baseline, and at 4 month (at the end of study)

  • Change from baseline SF-12 score at four months

    The outcome assessment was conducted at baseline, and at 4 month (at the end of study)

Study Arms (2)

Tai Chi group

EXPERIMENTAL

The Tai Chi group (i.e. the intervention group) received a 16-week Tai Chi program, of 32 sessions (2 sessions per week), each being one hour long.

Behavioral: Tai Chi

Ususal care group

NO INTERVENTION

The control group received the usual care offered by the respective centers. No intervention had been arranged for the control group during the study period. Participants in the control group were advised to attend different kinds of recreational activities provided by their community centers and to continue with their daily activities, including their usual general physical mobility and social activities.

Interventions

Tai ChiBEHAVIORAL
Tai Chi group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chinese people aged 60 years or above;
  • Obtained the CMMSE screening score ranging from 19 to 28, which was corrected based on educational level (≥ 18 for illiterate respondents and ≥ 22 for those having received more than two years of education);
  • Have ability to perform self-care functions on their own;
  • No confirmed diagnosis of dementia, depression or other psychiatric illnesses;
  • Not engaged in any structured physical exercise program or Tai Chi practice in the preceding year.

You may not qualify if:

  • Had a medical history of chronic alcoholism or brain trauma occurred in previous years; - Regular users of medications that could affect cognition;
  • Contraindicated light to moderate physical exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, 999077, Hong Kong

Location

Related Publications (2)

  • Siu MY, Lee DTF. Is Tai Chi an effective intervention for enhancing health-related quality of life in older people with mild cognitive impairment? An interventional study. Int J Older People Nurs. 2021 Sep;16(5):e12400. doi: 10.1111/opn.12400. Epub 2021 Jul 13.

  • Siu MY, Lee DTF. Effects of tai chi on cognition and instrumental activities of daily living in community dwelling older people with mild cognitive impairment. BMC Geriatr. 2018 Feb 2;18(1):37. doi: 10.1186/s12877-018-0720-8.

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Siu Mei Yi

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
All personals involved the study (participants, community center supporting staff, investigators and outcome assessors) had not masked for treatment assignment.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This interventional study involved two groups of participants, the experimental and usual-care control groups, with no randomization taking place. The participants were recruited from four community health centers and allocated to the experimental or control groups according to the centers to which they belonged.This arrangement avoided possible contamination of the experiment by diffusing the Tai Chi learning. The intervention group received a 16-week Tai Chi program, of 32 sessions (2 sessions per week), each being one hour long. The control group had no treatment regime and joined different recreational activity groups in the respective community centers as usual within the study period.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 8, 2018

First Posted

January 19, 2018

Study Start

December 15, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

January 19, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will share

All IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
The supporting information (as listed above) will become available starting from 1 year after publication for 6 months
Access Criteria
The datasets used and/or analyzed during the current study are available from the corresponding author ( Name: Siu Mei Yi at minniesiumy@gmail.com) on reasonable request. All data analyzed during this study are included in this published article and its supplementary information files.

Locations