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Tai Chi Versus Conventional Exercise to Improve Cognitive Performance in Older Adults With Mild Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Health Education
Conventional Exercise
Tai Chi
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:

  • 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).

Exclusion Criteria:

  • 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

Sites / Locations

  • The University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Active Comparator

Experimental

Arm Label

Health Education

Conventional Exercise

Tai Chi

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Clinical Dementia Rating
The Clinical Dementia Rating (CDR) is a numeric scale of 0-3 points based on clinician/ certified rater ratings of cognition and daily function in the domains of memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Rating from 0, 0.5, 1, 2 and 3 indicated subjects' cognitive function having healthy, very mild impairment, mild impairment, moderate impairment and severe impairment respectively.
Neurocognitive Test
The NIH Toolbox Cognitive Function Battery (CFB) will be used to objectively evaluate the various cognitive domains. CFB assesses cognitive abilities in different cognitive domains, including memory, executive function and attention. CFB will be delivered on a tablet computer.
Subjective Cognitive Performance
The Cognitive Self-Report Questionnaire (CSRQ) will be used to examine the subjective cognitive performance. The CSRQ is validated in Hong Kong and comprises 25 questions with an overall score ranging from 0-100. A higher score indicates worse self-perception on cognitive performance.
Subjective Memory complaints
The memory inventory for the Chinese - a questionnaire exploring subjective memory complaints and the effects on daily activities - will be performed to examine the subjective memory complaints.
Subjective Sleep Quality
The Pittsburgh Sleep Quality Index (PSQI) will be used to assess sleep quantity and the perceived restfulness and disturbance of sleep by gathering information on usual bed time, wake time, time to fall asleep, time of actual sleep, and quality of sleep. Each item is rated on a "0-3" Likert scale, with a higher score indicating poorer sleep quality.
The Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale assesses the severity of depression and anxiety. This 14-item questionnaire has subscales for both depression and anxiety and the overall score ranges from 0-21, with a higher score indicating more severe depressive/anxious symptoms.
The 12-Item Short Form Survey
The 12-Item Short Form Survey measures health-related quality of life. It has 12 items assessing physical functioning, emotional and mental health, bodily pain, general health, vitality, and social functioning, with higher overall scores indicating a better quality of life.
Medication Use
Subjects' use of medications, unrelated to dementia and psychiatric conditions (e.g., sleep, dyslipidemic and hypertensive pills) will be recorded along with detailed usage information. Data on medication dose and weekly frequency will be presented as the total number of lowest recommended dose in 7 days for the analysis.
Short Physical Performance Battery (SPPB) Test
Physical function and balancing performance will be assessed using the Short Physical Performance Battery (SPPB). The SPPB involves repeated timed chair stands, timed standing balance (with feet in parallel in semi-tandem and tandem positions), and a 4-meter walk to measure the usual gait speed.
Habitual Physical Activity
Actigraph/IPAQ method to monitor and record habitual physical activity. Actigraph activity monitor (wGT3X-BT or GT9X, Actigraph, USA), a 3-axis accelerometer, will be used to objectively determine the habitual daily physical movement/activities.

Full Information

First Posted
September 12, 2022
Last Updated
February 14, 2023
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05540613
Brief Title
Tai Chi Versus Conventional Exercise to Improve Cognitive Performance in Older Adults With Mild Cognitive Impairment
Official Title
Tai Chi Versus Conventional Exercise to Improve Cognitive Performance in Older Adults With Mild Cognitive Impairment (MCI): A Comparative Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

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
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.

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
315 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Health Education
Arm Type
Sham Comparator
Arm Description
A 26 weeks brain health and general health education program with two 1.5-hour sessions weekly.
Arm Title
Conventional Exercise
Arm Type
Active Comparator
Arm Description
A 26 weeks Conventional Exercise training with two 1.5-hour sessions weekly.
Arm Title
Tai Chi
Arm Type
Experimental
Arm Description
A 26 weeks Tai Chi training with two 1.5-hour sessions weekly.
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Intervention Description
A 26 weeks brain health and general health education program with two 1.5-hour sessions weekly.
Intervention Type
Behavioral
Intervention Name(s)
Conventional Exercise
Intervention Description
A 26 weeks Conventional Exercise training with two 1.5-hour sessions weekly.
Intervention Type
Behavioral
Intervention Name(s)
Tai Chi
Intervention Description
A 26 weeks Tai Chi training with two 1.5-hour sessions weekly.
Primary Outcome Measure Information:
Title
The score of the Montreal Cognitive Assessment (MoCA)
Description
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.
Time Frame
26 weeks
Title
The score of the Montreal Cognitive Assessment (MoCA)
Description
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.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Clinical Dementia Rating
Description
The Clinical Dementia Rating (CDR) is a numeric scale of 0-3 points based on clinician/ certified rater ratings of cognition and daily function in the domains of memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Rating from 0, 0.5, 1, 2 and 3 indicated subjects' cognitive function having healthy, very mild impairment, mild impairment, moderate impairment and severe impairment respectively.
Time Frame
26 weeks and 52 weeks
Title
Neurocognitive Test
Description
The NIH Toolbox Cognitive Function Battery (CFB) will be used to objectively evaluate the various cognitive domains. CFB assesses cognitive abilities in different cognitive domains, including memory, executive function and attention. CFB will be delivered on a tablet computer.
Time Frame
26 weeks and 52 weeks
Title
Subjective Cognitive Performance
Description
The Cognitive Self-Report Questionnaire (CSRQ) will be used to examine the subjective cognitive performance. The CSRQ is validated in Hong Kong and comprises 25 questions with an overall score ranging from 0-100. A higher score indicates worse self-perception on cognitive performance.
Time Frame
26 weeks and 52 weeks
Title
Subjective Memory complaints
Description
The memory inventory for the Chinese - a questionnaire exploring subjective memory complaints and the effects on daily activities - will be performed to examine the subjective memory complaints.
Time Frame
26 weeks and 52 weeks
Title
Subjective Sleep Quality
Description
The Pittsburgh Sleep Quality Index (PSQI) will be used to assess sleep quantity and the perceived restfulness and disturbance of sleep by gathering information on usual bed time, wake time, time to fall asleep, time of actual sleep, and quality of sleep. Each item is rated on a "0-3" Likert scale, with a higher score indicating poorer sleep quality.
Time Frame
26 weeks and 52 weeks
Title
The Hospital Anxiety and Depression Scale
Description
The Hospital Anxiety and Depression Scale assesses the severity of depression and anxiety. This 14-item questionnaire has subscales for both depression and anxiety and the overall score ranges from 0-21, with a higher score indicating more severe depressive/anxious symptoms.
Time Frame
26 weeks and 52 weeks
Title
The 12-Item Short Form Survey
Description
The 12-Item Short Form Survey measures health-related quality of life. It has 12 items assessing physical functioning, emotional and mental health, bodily pain, general health, vitality, and social functioning, with higher overall scores indicating a better quality of life.
Time Frame
26 weeks and 52 weeks
Title
Medication Use
Description
Subjects' use of medications, unrelated to dementia and psychiatric conditions (e.g., sleep, dyslipidemic and hypertensive pills) will be recorded along with detailed usage information. Data on medication dose and weekly frequency will be presented as the total number of lowest recommended dose in 7 days for the analysis.
Time Frame
26 weeks and 52 weeks
Title
Short Physical Performance Battery (SPPB) Test
Description
Physical function and balancing performance will be assessed using the Short Physical Performance Battery (SPPB). The SPPB involves repeated timed chair stands, timed standing balance (with feet in parallel in semi-tandem and tandem positions), and a 4-meter walk to measure the usual gait speed.
Time Frame
26 weeks and 52 weeks
Title
Habitual Physical Activity
Description
Actigraph/IPAQ method to monitor and record habitual physical activity. Actigraph activity monitor (wGT3X-BT or GT9X, Actigraph, USA), a 3-axis accelerometer, will be used to objectively determine the habitual daily physical movement/activities.
Time Frame
26 weeks and 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pak Hung Yu, PhD
Phone
67533806
Email
aphyu@connect.hku.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Parco Siu, PhD
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pak Hung Yu, Mphil
Phone
67533806
Email
aphyu@connect.hku.hk

12. IPD Sharing Statement

Plan to Share IPD
No

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Tai Chi Versus Conventional Exercise to Improve Cognitive Performance in Older Adults With Mild Cognitive Impairment

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