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

Not yet recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

350

Phase

  • 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

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
Intervention / Treatment
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

Outcome Measure
Measure Description
Time Frame
Montreal Cognitive Assessment
Time Frame: 12 weeks, 24 weeks
Global cognition
12 weeks, 24 weeks

Secondary Outcome Measures

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

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

Lidian Chen

Collaborators

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)

May 5, 2024

Primary Completion (Estimated)

June 15, 2025

Study Completion (Estimated)

December 15, 2025

Study Registration Dates

First Submitted

March 21, 2024

First Submitted That Met QC Criteria

April 16, 2024

First Posted (Actual)

April 19, 2024

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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