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Mild Cognitive ImpairmentNCT06372535

Effects of Tai Chi Chuan With Different Doses on Cognitive Function in Elderly Patients With Mild Cognitive Impairment

A study testing Tai Chi Chuan (dose 1), Tai Chi Chuan (dose 2) and Tai Chi Chuan (dose 3) in people with Mild Cognitive Impairment, run by Lidian Chen.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To determine the impact of Tai Chi Chuan with different exercise volume on cognitive function in elderly patients with mild cognitive impairment. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Mild Cognitive Impairment
What is being tested?
Tai Chi Chuan (dose 1), Tai Chi Chuan (dose 2) and Tai Chi Chuan (dose 3)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
540 participants
Where
No sites listed yet
Study dates
1 May 2024to 30 Sep 2025
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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Presence of mild cognitive impairment, not demented;
  • Age ≥ 60 years old;
  • Informed consent and voluntary participation.

Who cannot join

  • Geriatric Depression Scale score ≥ 9 points
  • Cognitive impairment caused by other reasons, taking drugs, poisoning, etc;
  • Suffer from severe musculoskeletal system diseases and other contraindications to exercise and are not suitable for Tai Chi training, such as those who suffer from stroke, Parkinson's disease, and have a history of lower limb arthritis, hip and knee joint replacement, etc;
  • Patients with severe heart, liver, kidney failure, malignant tumors, and other major diseases;
  • Individuals with visual/auditory impairments, writing/reading impairments, illiteracy, etc. that affect training and evaluation;
  • Individuals with uncontrolled hypertension (systolic blood pressure greater than 160mmHg or diastolic blood pressure greater than 100mmHg after medication);
  • Participating in other experiments that influence this study;
  • Engaged in regular exercise in the last three months (at least 3 times a week, at least 20 minutes of regular exercise each time.

About this study

Official title: Dose-Response Effects of Tai Chi Chuan Interventions on Cognitive Function in Mild Cognitive Impairment

To determine the impact of Tai Chi Chuan with different exercise volume on cognitive function in elderly patients with mild cognitive impairment.

Read the detailed description

Taking MCI as a potential gateway, early intervention to delay the occurrence of dementia has become an important consensus in this field. Exercise is an important means to improve cognitive function in MCI, but the effect of exercise is influenced by the dosage. Tai Chi Chuan, is a moderate intensity aerobic exercise. Previous studies by our team and others had confirmed its effect on cognitive function in MCI. However, the dose parameters of Tai Chi Chuan exercise varied in these studies, and the dose-response relationship is still unclear. The purpose of this study is to explore the dose-response relationship between different volume of Tai Chi Chuan exercise and cognitive function(global cognition and cognition of subdomains)in elderly MCI patients.

Being tested
Tai Chi Chuan (dose 1), Tai Chi Chuan (dose 2), Tai Chi Chuan (dose 3), Tai Chi Chuan (dose 4), Tai Chi Chuan (dose 5)
Keywords
Tai Chi Chuan, Cognitive Function, Dose-response
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 Chuan (dose 1)Behavioural

    Participants would take 24-form simplified Tai Chi Chuan 0.5 hour/session, 5 sessions/week for 8 weeks.

    There were 10 minutes warm-up, 30 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training.

  • Tai Chi Chuan (dose 2)Behavioural

    Participants would take 24-form simplified Tai Chi Chuan 0.5 hour/session, 5 sessions/week for 16 weeks.

    There were 10 minutes warm-up, 30 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training.

  • Tai Chi Chuan (dose 3)Behavioural

    Participants would take 24-form simplified Tai Chi Chuan 0.5 hour/session, 5 sessions/week for 24 weeks.

    There were 10 minutes warm-up, 30 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training.

  • Tai Chi Chuan (dose 4)Behavioural

    Participants would take 24-form simplified Tai Chi Chuan 1 hour/session, 5 sessions/week for 8 weeks.

    There were 10 minutes warm-up, 60 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training.

  • Tai Chi Chuan (dose 5)Behavioural

    Participants would take 24-form simplified Tai Chi Chuan 1 hour/session, 5 sessions/week for 16 weeks.

    There were 10 minutes warm-up, 60 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training.

  • Tai Chi Chuan (dose 6)Behavioural

    Participants would take 24-form simplified Tai Chi Chuan 1 hour/session, 5 sessions/week for 24 weeks.

    There were 10 minutes warm-up, 60 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training.

  • Tai Chi Chuan (dose 7)Behavioural

    Participants would take 24-form simplified Tai Chi Chuan 1.5 hour/session, 5 sessions/week for 8 weeks.

    There were 10 minutes warm-up, 90 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training.

  • Tai Chi Chuan (dose 8)Behavioural

    Participants would take 24-form simplified Tai Chi Chuan 1.5 hour/session, 5 sessions/week for 16 weeks.

    There were 10 minutes warm-up, 90 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training.

  • Tai Chi Chuan (dose 9)Behavioural

    Participants would take 24-form simplified Tai Chi Chuan 1.5 hour/session, 5 sessions/week for 24 weeks.

    There were 10 minutes warm-up, 90 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training.

Study groups in NCT06372535
Study groupRoleWhat they receive
Tai Chi Chuan Group1ExperimentalTai Chi Chuan 0.5 hour/session, 5 sessions/week for 8 weeks.
Receives: Behavioral: Tai Chi Chuan (dose 1)
Tai Chi Chuan Group2ExperimentalTai Chi Chuan 0.5 hour/session, 5 sessions/week for 16 weeks.
Receives: Behavioral: Tai Chi Chuan (dose 2)
Tai Chi Chuan Group3ExperimentalTai Chi Chuan 0.5 hour/session, 5 sessions/week for 24 weeks.
Receives: Behavioral: Tai Chi Chuan (dose 3)
Tai Chi Chuan Group4ExperimentalTai Chi Chuan 1 hour/session, 5 sessions/week for 8 weeks.
Receives: Behavioral: Tai Chi Chuan (dose 4)
Tai Chi Chuan Group5ExperimentalTai Chi Chuan 1 hour/session, 5 sessions/week for 16 weeks.
Receives: Behavioral: Tai Chi Chuan (dose 5)
Tai Chi Chuan Group6ExperimentalTai Chi Chuan 1 hour/session, 5 sessions/week for 24 weeks.
Receives: Behavioral: Tai Chi Chuan (dose 6)
Tai Chi Chuan Group7ExperimentalTai Chi Chuan 1.5 hour/session, 5 sessions/week for 8 weeks.
Receives: Behavioral: Tai Chi Chuan (dose 7)
Tai Chi Chuan Group8ExperimentalTai Chi Chuan 1.5 hour/session, 5 sessions/week for 16 weeks.
Receives: Behavioral: Tai Chi Chuan (dose 8)
Tai Chi Chuan Group9ExperimentalTai Chi Chuan 1.5 hour/session, 5 sessions/week for 24 weeks.
Receives: Behavioral: Tai Chi Chuan (dose 9)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Montreal Cognitive Assessment

    Global cognition

    Measured: 8 weeks, 16 weeks, 24 weeks

Secondary outcomes (8)
  1. Montreal Cognitive Assessment

    Global cognition

    Measured: 52 weeks

  2. Wechsler Memory Scale

    Memory function

    Measured: 8 weeks[the duration of intervention arm greater than or equal 8 weeks], 16 weeks [the duration of intervention arm greater than or equal 16 weeks], 24 weeks [the duration of intervention arm is 24 weeks] and 52 weeks

  3. Digital Symbol test

    Attention

    Measured: 8 weeks[the duration of intervention arm greater than or equal 8 weeks], 16 weeks [the duration of intervention arm greater than or equal 16 weeks], 24 weeks [the duration of intervention arm is 24 weeks] and 52 weeks

  4. Trial Making Test part B

    Executive function

    Measured: 8 weeks[the duration of intervention arm greater than or equal 8 weeks], 16 weeks [the duration of intervention arm greater than or equal 16 weeks], 24 weeks [the duration of intervention arm is 24 weeks] and 52 weeks

  5. Stroop color word test

    Processing speed

    Measured: 8 weeks[the duration of intervention arm greater than or equal 8 weeks], 16 weeks [the duration of intervention arm greater than or equal 16 weeks], 24 weeks [the duration of intervention arm is 24 weeks] and 52 weeks

  6. Boston naming test

    Verbal fluency

    Measured: 8 weeks[the duration of intervention arm greater than or equal 8 weeks], 16 weeks [the duration of intervention arm greater than or equal 16 weeks], 24 weeks [the duration of intervention arm is 24 weeks] and 52 weeks

  7. Rey-Osterrieth complex graphics test

    Rey-Osterrieth complex graphics test

    Measured: 8 weeks[the duration of intervention arm greater than or equal 8 weeks], 16 weeks [the duration of intervention arm greater than or equal 16 weeks], 24 weeks [the duration of intervention arm is 24 weeks] and 52 weeks

  8. Rey Auditory Verbal Learning Test

    Episodic memory

    Measured: 8 weeks[the duration of intervention arm greater than or equal 8 weeks], 16 weeks [the duration of intervention arm greater than or equal 16 weeks], 24 weeks [the duration of intervention arm is 24 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.

  1. First posted18 Apr 2024
  2. Study start1 May 2024 (estimated)
  3. Primary completion15 Jun 2025 (estimated)
  4. Study completion30 Sep 2025 (estimated)

Resources

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
540 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06372535
Sponsor's protocol ID
FujianUTCM-1
Status last verified
Apr 2024
First submitted
18 Mar 2024
Last updated
18 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Tai Chi Chuan (dose 1), Tai Chi Chuan (dose 2) and Tai Chi Chuan (dose 3) in people with Mild Cognitive Impairment, run by Lidian Chen.

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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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?

Montreal Cognitive Assessment (time frame: 8 weeks, 16 weeks, 24 weeks). 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 18 Apr 2024.

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