Mild Cognitive ImpairmentNCT04248400
Effectiveness of Tai Chi to Improve Cognitive Function in Older Adults With Mild Cognitive Impairment
A study testing Tai Chi training and Conventional exercise in people with Mild Cognitive Impairment, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. 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?
- Tai Chi training and Conventional exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteHong Kong
- Study dates
- 10 Oct 2018to 28 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Older adults aged equal or larger than 50 years
- Ethnic Chinese
- MCI under criteria of Mayo Clinic, including the following:
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Tai Chi training, Conventional exercise
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Chi trainingOther
A 24 weeks Tai Chi training with three 1-hour section per week
Conventional exerciseOther
A 24 weeks conventional exercise training with three 1-hour section per week
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No intervention |
| Conventional exercise | Active comparator | A 24 weeks conventional exercise training with three 1-hour section per week Receives: Other: Conventional exercise |
| Tai Chi | Experimental | A 24 weeks Tai Chi training with three 1-hour section per week Receives: Other: Tai Chi training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
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
Measured: 24 weeks
Secondary outcomes (6)
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.
Measured: 12 weeks and 24 weeks
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
Measured: 12 weeks and 24 weeks
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
Measured: 12 weeks and 24 weeks
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
Measured: 12 weeks and 24 weeks
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.
Measured: 12 weeks and 24 weeks
n-back test
Short term memory will be assessed by n-back test.
Measured: 12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start10 Oct 2018
- Primary completion3 Aug 2019
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 37 participants (actual)
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
- NCT04248400
- Sponsor's protocol ID
- TCMCI
- Status last verified
- Apr 2021
- First submitted
- 16 Jan 2020
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35614144
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Tai Chi to Improve Cognitive Function in Older Adults With Mild Cognitive Impairment: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04248400
- Acronym / sponsor ID
- TCMCI
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 3 Aug 2019 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 30 Jan 2020 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No intervention |
| Conventional exercise | Active comparator | Other: Conventional exerciseA 24 weeks conventional exercise training with three 1-hour section per week |
| Tai Chi | Experimental | Other: Tai Chi trainingA 24 weeks Tai Chi training with three 1-hour section per week |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Older adults aged equal or larger than 50 years
- Ethnic Chinese
- MCI under criteria of Mayo Clinic, including the following:
Key exclusion criteria (6 listed)
- 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),
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 |
|---|---|---|
| Tai Chi trainingA 24 weeks Tai Chi training with three 1-hour section per week | Other | Tai Chi |
| Conventional exerciseA 24 weeks conventional exercise training with three 1-hour section per week | Other | Conventional exercise |
Primary outcome
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
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
6 secondary outcomes
30-min delay recall
Time frame: 12 weeks and 24 weeks
Trial making test
Time frame: 12 weeks and 24 weeks
Stroop test
Time frame: 12 weeks and 24 weeks
Verbal fluency
Time frame: 12 weeks and 24 weeks
Digit span
Time frame: 12 weeks and 24 weeks
n-back test
Time frame: 12 weeks and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Derived from this study: PubMed 35614144Yu 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 Tai Chi training and Conventional exercise 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 6 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: finished, as of the sponsor's last update on 25 Aug 2021. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The score of the Montreal Cognitive Assessment (time frame: 12 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?
On the ClinicalTrials.gov record for NCT04248400, which also lists 1 linked publication.
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 25 Aug 2021.