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Effectiveness of Tai Chi to Improve Cognitive Function in Older Adults With Mild Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Tai Chi training
Conventional exercise
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)

Sites / Locations

  • The University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

Control

Conventional exercise

Tai Chi

Arm Description

No intervention

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

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

30-min delay recall
The 30-min delay recall test assesses long term memory. Ten words will be read to the participants. The participants will have to recall the 10 words after 30 minutes.
Trial making test
Executive function will be trial making test. The participants will be asked to connect a number of dots according to particular sequence. The time needed for the participant to connect all dots will be recorded. The shorter time the participant needed to connect all dots correctly indicate the better executive function of the participant
Stroop test
Attention will be assessed by stroop test. During the test, participants need to read out the colour of dots or words. The time needed to correctly named all colour of dots/words will be recorded. The faster the participant finished the test indicate the better attention of the participant
Verbal fluency
Verbal fluency test assesses the language domain of cognitive function. Participants need to name animals/ vegetable/ fruits as much as positive in 1 minutes. The more the participant named, the better of their language ability
Digit span
Working Memory will be assessed by digit span. Digit Span Forward requires the participants to repeat numbers in the same order as read by the assessors, and Digit Span Backward requires the participants to repeat the numbers in the reverse order of that presented by the assessors.
n-back test
Short term memory will be assessed by n-back test.

Full Information

First Posted
January 16, 2020
Last Updated
August 23, 2021
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04248400
Brief Title
Effectiveness of Tai Chi to Improve Cognitive Function in Older Adults With Mild Cognitive Impairment
Official Title
Effectiveness of Tai Chi to Improve Cognitive Function in Older Adults With Mild Cognitive Impairment: A Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 10, 2018 (Actual)
Primary Completion Date
August 3, 2019 (Actual)
Study Completion Date
February 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Arm Title
Conventional exercise
Arm Type
Active Comparator
Arm Description
A 24 weeks conventional exercise training with three 1-hour section per week
Arm Title
Tai Chi
Arm Type
Experimental
Arm Description
A 24 weeks Tai Chi training with three 1-hour section per week
Intervention Type
Other
Intervention Name(s)
Tai Chi training
Intervention Description
A 24 weeks Tai Chi training with three 1-hour section per week
Intervention Type
Other
Intervention Name(s)
Conventional exercise
Intervention Description
A 24 weeks conventional exercise training with three 1-hour section per week
Primary Outcome Measure Information:
Title
The score of the Montreal Cognitive Assessment
Description
Change in the score of the Montreal Cognitive Assessment. The score ranged from 0 to 30. Higher score indicates a better cognitive function
Time Frame
12 weeks
Title
The score of the Montreal Cognitive Assessment
Description
Change in the score of the Montreal Cognitive Assessment. The score ranged from 0 to 30. Higher score indicates a better cognitive function
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
30-min delay recall
Description
The 30-min delay recall test assesses long term memory. Ten words will be read to the participants. The participants will have to recall the 10 words after 30 minutes.
Time Frame
12 weeks and 24 weeks
Title
Trial making test
Description
Executive function will be trial making test. The participants will be asked to connect a number of dots according to particular sequence. The time needed for the participant to connect all dots will be recorded. The shorter time the participant needed to connect all dots correctly indicate the better executive function of the participant
Time Frame
12 weeks and 24 weeks
Title
Stroop test
Description
Attention will be assessed by stroop test. During the test, participants need to read out the colour of dots or words. The time needed to correctly named all colour of dots/words will be recorded. The faster the participant finished the test indicate the better attention of the participant
Time Frame
12 weeks and 24 weeks
Title
Verbal fluency
Description
Verbal fluency test assesses the language domain of cognitive function. Participants need to name animals/ vegetable/ fruits as much as positive in 1 minutes. The more the participant named, the better of their language ability
Time Frame
12 weeks and 24 weeks
Title
Digit span
Description
Working Memory will be assessed by digit span. Digit Span Forward requires the participants to repeat numbers in the same order as read by the assessors, and Digit Span Backward requires the participants to repeat the numbers in the reverse order of that presented by the assessors.
Time Frame
12 weeks and 24 weeks
Title
n-back test
Description
Short term memory will be assessed by n-back test.
Time Frame
12 weeks and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Parco Siu, PhD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Hong Kong
City
Hong Kong
ZIP/Postal Code
00
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35614144
Citation
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.
Results Reference
derived

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Effectiveness of Tai Chi to Improve Cognitive Function in Older Adults With Mild Cognitive Impairment

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