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

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ClinicalTrials.gov Identifier: NCT04248400
Recruitment Status : Recruiting
First Posted : January 30, 2020
Last Update Posted : January 30, 2020
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong

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.


Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Other: Tai Chi training Other: Meditation training Other: Conventional exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Tai Chi to Improve Cognitive Function in Older Adults With Mild Cognitive Impairment: A Pilot Randomized Controlled Trial
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : March 2021

Arm Intervention/treatment
No Intervention: Control
No intervention
Active Comparator: Meditation
A 24 weeks meditation training with three 1-hour section per week
Other: Meditation training
A 24 weeks meditation training with three 1-hour section per week

Active Comparator: Conventional exercise
A 24 weeks conventional exercise training with three 1-hour section per week
Other: Conventional exercise
A 24 weeks conventional exercise training with three 1-hour section per week

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




Primary Outcome Measures :
  1. The score of the Montreal Cognitive Assessment [ Time Frame: 48 weeks ]
    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 :
  1. 30-min delay recall [ Time Frame: 48 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.

  2. Trial making test [ Time Frame: 48 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

  3. Stroop test [ Time Frame: 48 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

  4. Verbal fluency [ Time Frame: 48 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

  5. Digit span [ Time Frame: 48 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.

  6. n-back test [ Time Frame: 48 weeks ]
    Short term memory will be assessed by n-back test.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 weekly)
  • Contraindications for MRI examination (e.g., metal body implant).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04248400


Contacts
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Contact: Pak Hung Yu, MPhil 67533806 aphyu@connect.hku.hk

Locations
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Hong Kong
The University of Hong Kong Recruiting
Hong Kong, Hong Kong, 00
Contact: Pak Hung Yu, MPhil    67533806    aphyu@connect.hku.hk   
Sub-Investigator: Pak Hung Yu, Mphil         
Sponsors and Collaborators
The University of Hong Kong

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Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT04248400    
Other Study ID Numbers: TCMCI
First Posted: January 30, 2020    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders