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

April 17, 2024 updated by: Lidian Chen

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

540

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 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
Tai Chi Chuan 0.5 hour/session, 5 sessions/week for 8 weeks.
Behavioral: Tai Chi Chuan （dose 1）

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.
Experimental: Tai Chi Chuan Group2
Tai Chi Chuan 0.5 hour/session, 5 sessions/week for 16 weeks.
Behavioral: Tai Chi Chuan （dose 2）

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.
Experimental: Tai Chi Chuan Group3
Tai Chi Chuan 0.5 hour/session, 5 sessions/week for 24 weeks.
Behavioral: Tai Chi Chuan （dose 3）

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.
Experimental: Tai Chi Chuan Group4
Tai Chi Chuan 1 hour/session, 5 sessions/week for 8 weeks.
Behavioral: Tai Chi Chuan （dose 4）

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.
Experimental: Tai Chi Chuan Group5
Tai Chi Chuan 1 hour/session, 5 sessions/week for 16 weeks.
Behavioral: Tai Chi Chuan （dose 5）

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.
Experimental: Tai Chi Chuan Group6
Tai Chi Chuan 1 hour/session, 5 sessions/week for 24 weeks.
Behavioral: Tai Chi Chuan （dose 6）

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.
Experimental: Tai Chi Chuan Group7
Tai Chi Chuan 1.5 hour/session, 5 sessions/week for 8 weeks.
Behavioral: Tai Chi Chuan （dose 7）

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.
Experimental: Tai Chi Chuan Group8
Tai Chi Chuan 1.5 hour/session, 5 sessions/week for 16 weeks.
Behavioral: Tai Chi Chuan （dose 8）

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.
Experimental: Tai Chi Chuan Group9
Tai Chi Chuan 1.5 hour/session, 5 sessions/week for 24 weeks.
Behavioral: Tai Chi Chuan （dose 9）

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montreal Cognitive Assessment
Time Frame: 8 weeks, 16 weeks, 24 weeks
Global cognition
8 weeks, 16 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: 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
Memory function
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
Digital Symbol test
Time Frame: 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
Attention
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
Trial Making Test part B
Time Frame: 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
Executive function
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
Stroop color word test
Time Frame: 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
Processing speed
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
Boston naming test
Time Frame: 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
Verbal fluency
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
Rey-Osterrieth complex graphics test
Time Frame: 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
Rey-Osterrieth complex graphics test
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
Rey Auditory Verbal Learning Test
Time Frame: 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
Episodic memory
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood glucose metabolism index
Time Frame: 8 weeks or 16 weeks or 24 weeks [post-intervention] and 52weeks
fasting blood glucose
8 weeks or 16 weeks or 24 weeks [post-intervention] and 52weeks
Blood lipid metabolism index
Time Frame: 8 weeks or 16 weeks or 24 weeks [post-intervention] and 52weeks
total cholesterol (TC), total triglyceride (TG), low density lipoprotein (LDL), high density lipoprotein (HDL)
8 weeks or 16 weeks or 24 weeks [post-intervention] and 52weeks
Functional Magnetic Resonance Imaging
Time Frame: 8 weeks or 16 weeks or 24 weeks [post-intervention]
Functional Magnetic Resonance Imaging
8 weeks or 16 weeks or 24 weeks [post-intervention]
Electroencephalogram
Time Frame: 8 weeks or 16 weeks or 24 weeks [post-intervention]
  1. Resting-State Electroencephalogram (EEG) Power Spectrum Changes. 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. Changes in the power of these frequency bands before and after the intervention are assessed to reflect changes in the level of brain activity.
  2. Task-Related Brain Electrophysiological Activity While performing specific cognitive tasks, brain activity is recorded using an Electroencephalogram (EEG), and task-related EEG event-related potentials are analyzed.
8 weeks or 16 weeks or 24 weeks [post-intervention]
Heart rate variability
Time Frame: 8 weeks or 16 weeks or 24 weeks [post-intervention]
cardiac autonomic modulations
8 weeks or 16 weeks or 24 weeks [post-intervention]
Gut microflora
Time Frame: 8 weeks or 16 weeks or 24 weeks [post-intervention] and 52weeks
16S rRNA amplification sequencing will be used to detect intestinal microbiota. Stool sample from each sub center will be stored within 1 h of collection at - 80 °C freezer. Subsequently, the fecal samples will be stored in dry ice and transported in batches to the laboratory within 8 hours, followed by storage in - 80 °C freezer.
8 weeks or 16 weeks or 24 weeks [post-intervention] and 52weeks
Sleep Quality
Time Frame: 8 weeks or 16 weeks or 24 weeks [post-intervention] and 52weeks
The Pittsburgh Sleep Quality Index will be used to evaluate sleep quality, with a total score of 0-21. The higher the score, the poorer the sleep quality.
8 weeks or 16 weeks or 24 weeks [post-intervention] and 52weeks
General health
Time Frame: 8 weeks or 16 weeks or 24 weeks [post-intervention] and 52weeks
12-Item Short Form Health Survey will be used to evaluate general health. the higher the total score, the better the individual's health status.
8 weeks or 16 weeks or 24 weeks [post-intervention] and 52weeks

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 1, 2024

Primary Completion (Estimated)

June 15, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

March 18, 2024

First Submitted That Met QC Criteria

April 17, 2024

First Posted (Actual)

April 18, 2024

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FujianUTCM-1

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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