NCT06375720

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2024

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 19, 2024

Completed
16 days until next milestone

Study Start

First participant enrolled

May 5, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

1.1 years

First QC Date

March 21, 2024

Last Update Submit

April 16, 2024

Conditions

Keywords

Tai Chi ChuanCognitive Function

Outcome Measures

Primary Outcomes (1)

  • Montreal Cognitive Assessment

    Global cognition

    12 weeks, 24 weeks

Secondary Outcomes (8)

  • Montreal Cognitive Assessment

    52 weeks

  • Wechsler Memory Scale

    12 weeks, 24 weeks and 52 weeks

  • Digit Symbol Substitution Test

    12 weeks, 24 weeks and 52 weeks

  • Trial Making Test part B

    12 weeks, 24 weeks and 52 weeks

  • Stroop Color Word Test

    12 weeks, 24 weeks and 52 weeks

  • +3 more secondary outcomes

Other Outcomes (8)

  • The Pittsburgh Sleep Quality Index (PSQI)

    12 weeks, 24 weeks and 52 weeks

  • 12-Item Short Form Health Survey

    12 weeks, 24 weeks and 52 weeks

  • Blood glucose metabolism index

    12 weeks, 24 weeks and 52 weeks

  • +5 more other outcomes

Study Arms (5)

Tai Chi Chuan Group1

EXPERIMENTAL

12 weeks of Tai Chi Chuan, 3x/week

Behavioral: Lower frequency, shorter period of Tai Chi Chuan

Tai Chi Chuan Group2

EXPERIMENTAL

12 weeks of Tai Chi Chuan, 5x/week

Behavioral: Higher frequency, shorter period of Tai Chi Chuan

Tai Chi Chuan Group3

EXPERIMENTAL

24 weeks of Tai Chi Chuan, 3x/week

Behavioral: Lower frequency, longer period of Tai Chi Chuan

Tai Chi Chuan Group4

EXPERIMENTAL

24 weeks of Tai Chi Chuan, 5x/week

Behavioral: Higher frequency, longer period of Tai Chi Chuan

Control

SHAM COMPARATOR

Participants would take standard health education 0.5hour/ session, 2 sessions/month for 6 months.

Behavioral: Standard Health Education

Interventions

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.

Tai Chi Chuan Group1

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.

Tai Chi Chuan Group2

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.

Tai Chi Chuan Group3

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.

Tai Chi Chuan Group4

Participants would take standard health education 0.5 hour/ session, 2 sessions/month for 6 months.

Control

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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 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;
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Fujian University of Traditional Chinese Medicine

Study Record Dates

First Submitted

March 21, 2024

First Posted

April 19, 2024

Study Start

May 5, 2024

Primary Completion

June 15, 2025

Study Completion

December 15, 2025

Last Updated

April 19, 2024

Record last verified: 2024-04