NCT06372535

Brief Summary

To determine the impact of Tai Chi Chuan with different exercise volume on cognitive function in elderly patients 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
540

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 18, 2024

Completed
13 days until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

April 18, 2024

Status Verified

April 1, 2024

Enrollment Period

1.1 years

First QC Date

March 18, 2024

Last Update Submit

April 17, 2024

Conditions

Keywords

Tai Chi ChuanCognitive FunctionDose-response

Outcome Measures

Primary Outcomes (1)

  • Montreal Cognitive Assessment

    Global cognition

    8 weeks, 16 weeks, 24 weeks

Secondary Outcomes (8)

  • Montreal Cognitive Assessment

    52 weeks

  • Wechsler Memory Scale

    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

    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

    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

    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 more secondary outcomes

Other Outcomes (8)

  • Blood glucose metabolism index

    8 weeks or 16 weeks or 24 weeks [post-intervention] and 52weeks

  • Blood lipid metabolism index

    8 weeks or 16 weeks or 24 weeks [post-intervention] and 52weeks

  • Functional Magnetic Resonance Imaging

    8 weeks or 16 weeks or 24 weeks [post-intervention]

  • +5 more other outcomes

Study Arms (9)

Tai Chi Chuan Group1

EXPERIMENTAL

Tai Chi Chuan 0.5 hour/session, 5 sessions/week for 8 weeks.

Behavioral: Tai Chi Chuan (dose 1)

Tai Chi Chuan Group2

EXPERIMENTAL

Tai Chi Chuan 0.5 hour/session, 5 sessions/week for 16 weeks.

Behavioral: Tai Chi Chuan (dose 2)

Tai Chi Chuan Group3

EXPERIMENTAL

Tai Chi Chuan 0.5 hour/session, 5 sessions/week for 24 weeks.

Behavioral: Tai Chi Chuan (dose 3)

Tai Chi Chuan Group4

EXPERIMENTAL

Tai Chi Chuan 1 hour/session, 5 sessions/week for 8 weeks.

Behavioral: Tai Chi Chuan (dose 4)

Tai Chi Chuan Group5

EXPERIMENTAL

Tai Chi Chuan 1 hour/session, 5 sessions/week for 16 weeks.

Behavioral: Tai Chi Chuan (dose 5)

Tai Chi Chuan Group6

EXPERIMENTAL

Tai Chi Chuan 1 hour/session, 5 sessions/week for 24 weeks.

Behavioral: Tai Chi Chuan (dose 6)

Tai Chi Chuan Group7

EXPERIMENTAL

Tai Chi Chuan 1.5 hour/session, 5 sessions/week for 8 weeks.

Behavioral: Tai Chi Chuan (dose 7)

Tai Chi Chuan Group8

EXPERIMENTAL

Tai Chi Chuan 1.5 hour/session, 5 sessions/week for 16 weeks.

Behavioral: Tai Chi Chuan (dose 8)

Tai Chi Chuan Group9

EXPERIMENTAL

Tai Chi Chuan 1.5 hour/session, 5 sessions/week for 24 weeks.

Behavioral: Tai Chi Chuan (dose 9)

Interventions

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 Group1

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 Group2

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 Group3

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 Group4

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 Group5

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 Group6

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 Group7

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 Group8

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.

Tai Chi Chuan Group9

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 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
PhD

Study Record Dates

First Submitted

March 18, 2024

First Posted

April 18, 2024

Study Start

May 1, 2024

Primary Completion

June 15, 2025

Study Completion

September 30, 2025

Last Updated

April 18, 2024

Record last verified: 2024-04