Efficacy of Different Doses of Tai Chi Chuan on Cognitive Function in Persons With Mild Cognitive Impairment

April 16, 2024 updated by: Lidian Chen

Dose-effect of Different Frequencies and Duration of Tai Chi Chuan to Improve Cognitive Function in Persons With Mild Cognitive Impairment

To determine the relationship between the effects of different frequencies and duration of Tai Chi Chuan in dose parameters to improve cognitive function in elderly persons with mild cognitive impairment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Mild cognitive impairment (MCI) is regarded as a prodrome to dementia and affects 16% to 20% of people aged older than 65 years. Tai Chi Chuan is an increasingly popular multi-modal physical and mental exercise. Studies have shown that Tai Chi Chuan can effectively improve the cognitive function of elderly persons with MCI. However, the relationship between the effects of different frequencies and duration of Tai Chi Chuan to improve the cognitive function of elderly persons with MCI is not yet clear. The purpose of this study is to determine the optimal frequency and duration of Tai Chi Chuan. The investigators will conduct a single-blind, randomized controlled trial in 350 persons who meet the presence of MCI without dementia. Persons will be randomly assigned to either the Tai Chi Chuan intervention group once or twice a week for 12 or 24 weeks, or the health education control group once every four weeks for 24 weeks. All groups will be followed for 52 weeks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
350

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Geriatric Depression Scale score ≥ 9 points;
  2. Cognitive impairment caused by other reasons, taking drugs, poisoning, etc;
  3. Suffer from severe musculoskeletal system diseases and other contraindications to exercise and are not suitable for Tai Chi Chuan 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;
  4. Patients with severe heart, liver, kidney failure, malignant tumors, and other major diseases;
  5. Individuals with visual/auditory impairments, writing/reading impairments, illiteracy, etc. that affect training and evaluation;
  6. Individuals with uncontrolled hypertension (systolic blood pressure greater than 160mmHg or diastolic blood pressure greater than 100mmHg after medication);
  7. Participating in other experiments that influence this study;
  8. Engaged in regular exercise in the last three months (at least 3 times a week, at least 20 minutes of regular exercise each time).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tai Chi Chuan Group1
12 weeks of Tai Chi Chuan, 3x/week
Behavioral: Lower frequency, shorter period of Tai Chi Chuan
Participants would take 24-form simplified Tai Chi Chuan 1 hour/session, 3 sessions/week for 12 weeks. There were 10 minutes warm-up, 40 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training. Besides, they would also take standard health education 0.5 hour/session, 2 sessions/month for 6 months.
Experimental: Tai Chi Chuan Group2
12 weeks of Tai Chi Chuan, 5x/week
Behavioral: Higher frequency, shorter period of Tai Chi Chuan
Participants would take 24-form simplified Tai Chi Chuan 1 hour/session, 5 sessions/week for 12 weeks. There were 10 minutes warm-up, 40 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training. Besides, they would also take standard health education 0.5 hour/session, 2 sessions/month for 6 months.
Experimental: Tai Chi Chuan Group3
24 weeks of Tai Chi Chuan, 3x/week
Behavioral: Lower frequency, longer period of Tai Chi Chuan
Participants would take 24-form simplified Tai Chi Chuan 1 hour/session, 3 sessions/week for 24 weeks. There were 10 minutes warm-up, 40 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training. Besides, they would also take standard health education 0.5 hour/session, 2 sessions/month for 6 months.
Experimental: Tai Chi Chuan Group4
24 weeks of Tai Chi Chuan, 5x/week
Behavioral: Higher frequency, longer period of Tai Chi Chuan
Participants would take 24-form simplified Tai Chi Chuan 1 hour/session, 5 sessions/week for 24 weeks. There were 10 minutes warm-up, 40 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training. Besides, they would also take standard health education 0.5 hour/session, 2 sessions/month for 6 months.
Sham Comparator: Control
Participants would take standard health education 0.5hour/ session, 2 sessions/month for 6 months.
Behavioral: Standard Health Education
Participants would take standard health education 0.5 hour/ session, 2 sessions/month for 6 months.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Montreal Cognitive Assessment
Time Frame: 12 weeks, 24 weeks
Global cognition
12 weeks, 24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Montreal Cognitive Assessment
Time Frame: 52 weeks
Global cognition
52 weeks
Wechsler Memory Scale
Time Frame: 12 weeks, 24 weeks and 52 weeks
Memory function
12 weeks, 24 weeks and 52 weeks
Digit Symbol Substitution Test
Time Frame: 12 weeks, 24 weeks and 52 weeks
Attention
12 weeks, 24 weeks and 52 weeks
Trial Making Test part B
Time Frame: 12 weeks, 24 weeks and 52 weeks
Executive Function
12 weeks, 24 weeks and 52 weeks
Stroop Color Word Test
Time Frame: 12 weeks, 24 weeks and 52 weeks
Processing Speed
12 weeks, 24 weeks and 52 weeks
Boston Naming Test
Time Frame: 12 weeks, 24 weeks and 52 weeks
Verbal fluency
12 weeks, 24 weeks and 52 weeks
Rey-Osterrieth Complex Graphics Test
Time Frame: 12 weeks, 24 weeks and 52 weeks
Visuo-spatial ability
12 weeks, 24 weeks and 52 weeks
Rey Auditory Verbal Learning Test
Time Frame: 12 weeks, 24 weeks and 52 weeks
Episodic memory
12 weeks, 24 weeks and 52 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 12 weeks, 24 weeks and 52 weeks
Sleep quality
12 weeks, 24 weeks and 52 weeks
12-Item Short Form Health Survey
Time Frame: 12 weeks, 24 weeks and 52 weeks
General health
12 weeks, 24 weeks and 52 weeks
Blood glucose metabolism index
Time Frame: 12 weeks, 24 weeks and 52 weeks
fasting blood glucose
12 weeks, 24 weeks and 52 weeks
Blood lipid metabolism index
Time Frame: 12 weeks, 24 weeks and 52 weeks
total cholesterol (TC); total triglyceride (TG); low density lipoprotein (LDL);high density lipoprotein (HDL)
12 weeks, 24 weeks and 52 weeks
functional Magnetic Resonance Imaging
Time Frame: 12 weeks or 24 weeks [post-intervention]
functional Magnetic Resonance Imaging
12 weeks or 24 weeks [post-intervention]
Electroencephalogram
Time Frame: 12 weeks or 24 weeks [post-intervention]
The power spectrum density of the brain in a relaxed state is measured using a resting-state electroencephalogram (EEG) for the delta (1-4 Hz), theta (4-8 Hz), alpha (8-13 Hz), beta (13-30 Hz), and gamma (30-100 Hz) bands.
12 weeks or 24 weeks [post-intervention]
Heart rate variability
Time Frame: 12 weeks or 24 weeks [post-intervention]
Cardiac autonomic modulations
12 weeks or 24 weeks [post-intervention]
Gut microflora
Time Frame: 12 weeks, 24 weeks and 52 weeks
16S rRNA amplification sequencing was used to detect intestinal microbiota.
12 weeks, 24 weeks and 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lidian Chen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 5, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FujianUTCM-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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