- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04248400
Effectiveness of Tai Chi to Improve Cognitive Function in Older Adults With Mild Cognitive Impairment
Effectiveness of Tai Chi to Improve Cognitive Function in Older Adults With Mild Cognitive Impairment: A Pilot Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hong Kong, Hong Kong, 00
- The University of Hong Kong
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
No intervention
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|
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Active Comparator: Conventional exercise
A 24 weeks conventional exercise training with three 1-hour section per week
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A 24 weeks conventional exercise training with three 1-hour section per week
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Experimental: Tai Chi
A 24 weeks Tai Chi training with three 1-hour section per week
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A 24 weeks Tai Chi training with three 1-hour section per week
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The score of the Montreal Cognitive Assessment
Time Frame: 12 weeks
|
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
Time Frame: 24 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
30-min delay recall
Time Frame: 12 weeks and 24 weeks
|
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.
|
12 weeks and 24 weeks
|
|
Trial making test
Time Frame: 12 weeks and 24 weeks
|
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
|
12 weeks and 24 weeks
|
|
Stroop test
Time Frame: 12 weeks and 24 weeks
|
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
|
12 weeks and 24 weeks
|
|
Verbal fluency
Time Frame: 12 weeks and 24 weeks
|
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
|
12 weeks and 24 weeks
|
|
Digit span
Time Frame: 12 weeks and 24 weeks
|
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.
|
12 weeks and 24 weeks
|
|
n-back test
Time Frame: 12 weeks and 24 weeks
|
Short term memory will be assessed by n-back test.
|
12 weeks and 24 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TCMCI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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