NCT05540613

Brief Summary

This randomized controlled trial aims to evaluate the effectiveness of Tai Chi and conventional exercise on improving cognitive function in older adults with mild cognitive impairment (MCI). Participants will be randomized into three six-month programmes, namely Health Education group, Tai Chi group and Conventional Exercise group. Assessments will be conducted at baseline, after the 26-week interventions, and 26-week after the competition of the intervention.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
315

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

December 11, 2024

Status Verified

December 1, 2024

Enrollment Period

2.2 years

First QC Date

September 12, 2022

Last Update Submit

December 5, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • The score of the Montreal Cognitive Assessment (MoCA)

    Change in the score of the Montreal Cognitive Assessment. The score ranged from 0 to 30. Higher score indicates a better cognitive function. Participants scoring equal or below the 7th percentile of the age- and education-corrected normative data will be considered as having MCI.

    26 weeks

  • The score of the Montreal Cognitive Assessment (MoCA)

    Change in the score of the Montreal Cognitive Assessment. The score ranged from 0 to 30. Higher score indicates a better cognitive function. Participants scoring equal or below the 7th percentile of the age- and education-corrected normative data will be considered as having MCI.

    52 weeks

Secondary Outcomes (10)

  • Clinical Dementia Rating

    26 weeks and 52 weeks

  • Neurocognitive Test

    26 weeks and 52 weeks

  • Subjective Cognitive Performance

    26 weeks and 52 weeks

  • Subjective Memory complaints

    26 weeks and 52 weeks

  • Subjective Sleep Quality

    26 weeks and 52 weeks

  • +5 more secondary outcomes

Study Arms (3)

Health Education

SHAM COMPARATOR

A 26 weeks brain health and general health education program with two 1.5-hour sessions weekly.

Behavioral: Health Education

Conventional Exercise

ACTIVE COMPARATOR

A 26 weeks Conventional Exercise training with two 1.5-hour sessions weekly.

Behavioral: Conventional Exercise

Tai Chi

EXPERIMENTAL

A 26 weeks Tai Chi training with two 1.5-hour sessions weekly.

Behavioral: Tai Chi

Interventions

A 26 weeks brain health and general health education program with two 1.5-hour sessions weekly.

Health Education

A 26 weeks Conventional Exercise training with two 1.5-hour sessions weekly.

Conventional Exercise
Tai ChiBEHAVIORAL

A 26 weeks Tai Chi training with two 1.5-hour sessions weekly.

Tai Chi

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chinese older adults aged equal or larger than 50 years
  • Ethnic Chinese
  • MCI under criteria of Mayo Clinic, including the following
  • i. people with subjective complaint about a decline in cognitive function. ii. total score in the Montreal Cognitive Assessment is equal or below the 7th percentile of the age- and education- corrected normative data of Hong Kong. iii. the decline in cognitive function does not impair daily functioning, as revealed by getting ≥2 marks in every item on the Chinese Lawton Instrumental Activities of Daily Living 4-point Scale).

You may not qualify if:

  • medical history of major chronic diseases such as cancer, stroke, cerebro- and cardio-vascular diseases, and renal disease
  • uncontrolled diabetes
  • diagnosed with dementia or using anti-dementia medication
  • diagnosed with psychiatric diseases or using psychiatric medication
  • with diseases or on medications known to severely affect cognitive performance
  • somatic condition (e.g., limb lost) that prevent participation in exercise
  • impaired mobility by chronic diseases (e.g., neurological, musculoskeletal and autoimmune diseases)
  • incapable to perform physical exercise
  • regular exercise habit (\>3 times 60-min Tai Chi or moderate-intensity conventional exercise weekly) in the past 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, 00, Hong Kong

RECRUITING

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

  • Parco Siu, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pak Hung Yu, PhD

CONTACT

Parco Siu, PhD

CONTACT

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

September 12, 2022

First Posted

September 14, 2022

Study Start

November 1, 2022

Primary Completion

January 1, 2025

Study Completion

January 1, 2026

Last Updated

December 11, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations