NCT04248400

Brief Summary

Mild cognitive impairment (MCI) is a transitional state between normal cognitive decline and dementia. Individuals with MCI are having an impairment in cognitive function compared with normal age-matched counterparts, while their cognitive function is still sufficient for their daily function. The prevalent rate of MCI is ranging from 10% to 20%. Patients with MCI are more susceptible to dementia with annual conversion rate between 5% and 20%. It is well-known that dementia not only lead to devastating consequences to the patients and their care-givers, but also immense healthcare and socioeconomic burdens. The growing prevalence of MCI in our rapidly aging population warrants immediate action to identify effective interventions to prevent progression of the cognitive impairment and its conversion to dementia. Currently, there is no pharmaceutical treatment proven to be effective in alleviating the cognitive decline in MCI patients. Nonetheless, previous researches have demonstrated that mind activity, physical exercise and social engagement are all have positive effects in alleviating the cognitive decline in MCI patients. Tai Chi is a traditional form of Chinese mind-body exercise that consists of both physical exercise and meditation component. Practicing Tai Chi can also facilitate social engagement as people usually practice in group. Tai Chi is expected to be more acceptable to the older adults for incorporating it with their daily life to preserve cognitive function, compared with conventional physical activity modalities (e.g., running/jogging and gym-based resistance training). Preliminary evidences suggest the potential of Tai Chi for alleviating cognitive decline in older adults. A randomized controlled trial is needed to conclude on the therapeutic use of Tai Chi before it can be large-scale implemented at community level. This study seeks to extend previous findings of the beneficial effects of Tai Chi on cognitive function in older adults with MCI and examine the impact of Tai Chi training in protecting older adults with MCI from developing dementia. This study also attempt to delineate the behind mechanism of Tai Chi on alleviating cognitive decline by including measurements in neuroimaging and blood markers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

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

October 10, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 30, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
Last Updated

August 25, 2021

Status Verified

April 1, 2021

Enrollment Period

10 months

First QC Date

January 16, 2020

Last Update Submit

August 23, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • The score of the Montreal Cognitive Assessment

    Change in the score of the Montreal Cognitive Assessment. The score ranged from 0 to 30. Higher score indicates a better cognitive function

    12 weeks

  • The score of the Montreal Cognitive Assessment

    Change in the score of the Montreal Cognitive Assessment. The score ranged from 0 to 30. Higher score indicates a better cognitive function

    24 weeks

Secondary Outcomes (6)

  • 30-min delay recall

    12 weeks and 24 weeks

  • Trial making test

    12 weeks and 24 weeks

  • Stroop test

    12 weeks and 24 weeks

  • Verbal fluency

    12 weeks and 24 weeks

  • Digit span

    12 weeks and 24 weeks

  • +1 more secondary outcomes

Study Arms (3)

Control

NO INTERVENTION

No intervention

Conventional exercise

ACTIVE COMPARATOR

A 24 weeks conventional exercise training with three 1-hour section per week

Other: Conventional exercise

Tai Chi

EXPERIMENTAL

A 24 weeks Tai Chi training with three 1-hour section per week

Other: Tai Chi training

Interventions

A 24 weeks Tai Chi training with three 1-hour section per week

Tai Chi

A 24 weeks conventional exercise training with three 1-hour section per week

Conventional exercise

Eligibility Criteria

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

You may qualify if:

  • Older adults aged equal or larger than 50 years
  • Ethnic Chinese
  • MCI under criteria of Mayo Clinic, including the following:
  • i. Participants have noticed a decline in their cognitive function ii. The total score of participants in age and education corrected Hong Kong version Montreal Cognitive assessment is below the 7th percentile of the normative data from Hong Kong iii. The decline of cognitive function does not affect the daily function of the participants revealed by getting ≥2 marks in every item of Chinese Lawton Instrumental Activities of Daily Living Scale (4-point Scale)

You may not qualify if:

  • History of major diseases such as cancer, stroke, cardio-/cerebrovascular, neurodegenerative and renal diseases,
  • Diagnosis of dementia or using anti-dementia medication,
  • Diagnosis of psychiatric disease or using psychiatric medication,
  • Inability to perform exercise,
  • Regular mind-body exercise habit (\>3 times 60-minute Tai Chi, yoga or Qigong weekly),
  • Physically active (\>150 minutes of moderate-intensity physical activity or \>75 minutes of vigorous-intensity physical activity weekly)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, 00, Hong Kong

Location

Related Publications (1)

  • Yu AP, Chin EC, Yu DJ, Fong DY, Cheng CP, Hu X, Wei GX, Siu PM. Tai Chi versus conventional exercise for improving cognitive function in older adults: a pilot randomized controlled trial. Sci Rep. 2022 May 25;12(1):8868. doi: 10.1038/s41598-022-12526-5.

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Parco Siu, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

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

January 16, 2020

First Posted

January 30, 2020

Study Start

October 10, 2018

Primary Completion

August 3, 2019

Study Completion

February 28, 2020

Last Updated

August 25, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations