Mild Cognitive ImpairmentNCT05540613
Tai Chi Versus Conventional Exercise to Improve Cognitive Performance in Older Adults With Mild Cognitive Impairment
A study testing Health Education, Conventional Exercise and Tai Chi in people with Mild Cognitive Impairment, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Health Education, Conventional Exercise and Tai Chi
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 315 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Nov 2022to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chinese older adults aged equal or larger than 50 years
- Ethnic Chinese
- MCI under criteria of Mayo Clinic, including the following
- 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).
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Parco Siu, PhD contact
Hong Kong1 site, 1 recruiting
- Recruiting
The University of Hong Kong
Hong Kong, 00
Pak Hung Yu, Mphil, 67533806, aphyu@connect.hku.hk
About this study
Official title: Tai Chi Versus Conventional Exercise to Improve Cognitive Performance in Older Adults With Mild Cognitive Impairment (MCI): A Comparative Randomized Controlled Trial
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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Health Education, Conventional Exercise, Tai Chi
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health EducationBehavioural
A 26 weeks brain health and general health education program with two 1.5-hour sessions weekly.
Conventional ExerciseBehavioural
A 26 weeks Conventional Exercise training with two 1.5-hour sessions weekly.
Tai ChiBehavioural
A 26 weeks Tai Chi training with two 1.5-hour sessions weekly.
| Study group | Role | What they receive |
|---|---|---|
| Health Education | Sham comparator | A 26 weeks brain health and general health education program with two 1.5-hour sessions weekly. Receives: Behavioral: Health Education |
| Conventional Exercise | Active comparator | A 26 weeks Conventional Exercise training with two 1.5-hour sessions weekly. Receives: Behavioral: Conventional Exercise |
| Tai Chi | Experimental | A 26 weeks Tai Chi training with two 1.5-hour sessions weekly. Receives: Behavioral: Tai Chi |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 26 weeks
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.
Measured: 52 weeks
Secondary outcomes (10)
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.
Measured: 26 weeks and 52 weeks
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.
Measured: 26 weeks and 52 weeks
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.
Measured: 26 weeks and 52 weeks
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.
Measured: 26 weeks and 52 weeks
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.
Measured: 26 weeks and 52 weeks
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.
Measured: 26 weeks and 52 weeks
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.
Measured: 26 weeks and 52 weeks
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.
Measured: 26 weeks and 52 weeks
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.
Measured: 26 weeks and 52 weeks
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.
Measured: 26 weeks and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start1 Nov 2022
- Primary completionJan 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 315 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Parco Siu, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05540613
- Sponsor's protocol ID
- TC_MCI_RCT
- Status last verified
- Dec 2024
- First submitted
- 12 Sep 2022
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tai Chi Versus Conventional Exercise to Improve Cognitive Performance in Older Adults With Mild Cognitive Impairment (MCI): A Comparative Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05540613
- Acronym / sponsor ID
- TC_MCI_RCT
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 315 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 14 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Health Education | Sham comparator | Behavioral: Health EducationA 26 weeks brain health and general health education program with two 1.5-hour sessions weekly. |
| Conventional Exercise | Active comparator | Behavioral: Conventional ExerciseA 26 weeks Conventional Exercise training with two 1.5-hour sessions weekly. |
| Tai Chi | Experimental | Behavioral: Tai ChiA 26 weeks Tai Chi training with two 1.5-hour sessions weekly. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chinese older adults aged equal or larger than 50 years
- Ethnic Chinese
- MCI under criteria of Mayo Clinic, including the following
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health EducationA 26 weeks brain health and general health education program with two 1.5-hour sessions weekly. | Behavioural | Health Education |
| Conventional ExerciseA 26 weeks Conventional Exercise training with two 1.5-hour sessions weekly. | Behavioural | Conventional Exercise |
| Tai ChiA 26 weeks Tai Chi training with two 1.5-hour sessions weekly. | Behavioural | Tai Chi |
Primary outcome
The score of the Montreal Cognitive Assessment (MoCA)
Time frame: 26 weeks
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)
Time frame: 52 weeks
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.
10 secondary outcomes
Clinical Dementia Rating
Time frame: 26 weeks and 52 weeks
Neurocognitive Test
Time frame: 26 weeks and 52 weeks
Subjective Cognitive Performance
Time frame: 26 weeks and 52 weeks
Subjective Memory complaints
Time frame: 26 weeks and 52 weeks
Subjective Sleep Quality
Time frame: 26 weeks and 52 weeks
The Hospital Anxiety and Depression Scale
Time frame: 26 weeks and 52 weeks
The 12-Item Short Form Survey
Time frame: 26 weeks and 52 weeks
Medication Use
Time frame: 26 weeks and 52 weeks
Short Physical Performance Battery (SPPB) Test
Time frame: 26 weeks and 52 weeks
Habitual Physical Activity
Time frame: 26 weeks and 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Mild Cognitive Impairment
Enrolling by invitationPhase 2
Tau PET Outcomes With Anti-amyloid Immunotherapies
Cognitive Impairment, Mild, Dementia, Mild
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingPhase 1
A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease
Alzheimer Disease
Recruiting
Non-invasive Brain Stimulation for the Treatment of Mild Cognitive Impairment in Parkinson's Disease
Parkinson Disease, Mild Cognitive Impairment
RecruitingObservational study
Loneliness as Risk Factor for Dementia
Mild Cognitive Impairment (MCI), Dementia (Diagnosis)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Parco Siu, PhD contact
Parco Siu, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Education, Conventional Exercise and Tai Chi in people with Mild Cognitive Impairment, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pak Hung Yu, PhD (67533806, aphyu@connect.hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The score of the Montreal Cognitive Assessment (MoCA) (time frame: 26 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.