NCT04070703

Brief Summary

To determine the efficacy of a cognitively enhanced exercise intervention - Tai Ji Quan: Moving to Maintain Brain Health in improving global cognitive function and dual-task ability in older adults with mild cognitive impairment.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
318

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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

August 26, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

October 15, 2019

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

August 26, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

August 26, 2025

Status Verified

August 1, 2025

Enrollment Period

4.1 years

First QC Date

August 26, 2019

Results QC Date

March 28, 2025

Last Update Submit

August 22, 2025

Conditions

Keywords

Cognitive functionmild cognitive impairmentTai Ji Quan

Outcome Measures

Primary Outcomes (2)

  • Montreal Cognitive Assessment

    The Montreal Cognitive Assessment scale measures change in global cognitive function from baseline to 6 months. The scale scores range from 0 to 30 points, with higher scores indicating better cognitive functioning.

    baseline, 6 months

  • Gait Performance Under a Dual-task Condition

    Assessing change in dual-task ability (measured in seconds) from baseline to 6 months. Change will be assessed via an Instrumental Timed Up\&Go (iTUG) gait performance (APDM, Inc.) in which the participant is asked to stand up from a chair, walk a 6-m walkway at normal pace (3 m toward a line, turn, and 3 m toward the chair), turn around, and sit down on the chair, with no cognitive task (single-task walking). The participant is then asked to perform the same procedure with a concurrent cognitive task (counting backward by 3s, starting with an odd number, e.g., 81).12 The total walking duration (in seconds) during both 6-meter walks, at normal pace, will be recorded. Lower duration indicates a better outcome.

    baseline, 6 months

Secondary Outcomes (8)

  • Clinical Dementia Rating Scale

    baseline, 6 months

  • Domain-specific Cognitive Test - Trail Making - B

    baseline, 6 months

  • 4-Stage Balance Test

    baseline, 6 months

  • Backward Digit Span

    baseline, 6 months

  • Verbal Fluency Test

    baseline, 6 months

  • +3 more secondary outcomes

Other Outcomes (6)

  • Sleep Quality - Pittsburgh Sleep Quality Index (PSQI)

    baseline, 6 months

  • Depression - Geriatric Depression Scale (GDS)

    baseline, 6 months

  • Activity and Movement Confidence Scales

    baseline, 6 months

  • +3 more other outcomes

Study Arms (3)

Cognitively enhanced Tai Ji Quan

EXPERIMENTAL

Participants in this arm will exercise a series of Tai Ji Quan-based movements with configurations that are specifically designed for older adults to improve cognitive function, dual-task ability, strength/balance, and mobility.

Behavioral: The Go for Exercise & Healthy Aging Project

Standard Tai Ji Quan

ACTIVE COMPARATOR

Serving as an active comparison arm, participants in this intervention will exercise a series of Tai Ji Quan-based movements that are specifically designed for older adults to improve strength/balance, cognitive function, and mobility.

Behavioral: The Go for Exercise & Healthy Aging Project

Stretching

SHAM COMPARATOR

Serving as a control arm, participants in this intervention will engage in a series of light exercise activities consisting of breathing, stretching, and body relaxation.

Behavioral: The Go for Exercise & Healthy Aging Project

Interventions

Exercise and Cognition

Cognitively enhanced Tai Ji QuanStandard Tai Ji QuanStretching

Eligibility Criteria

Age65 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • complaint of memory loss
  • clinical dementia rating (CDR) scale score ≤0.5
  • having normal general cognitive function screened, with MMSE ≥24
  • capable of exercising safely, as determined by a healthcare provider
  • willingness to be randomly assigned to an intervention condition and complete the 24-week intervention and 6-month follow-up

You may not qualify if:

  • having medical conditions likely to compromise survival, such as metastatic cancer, or render a participant unable to engage in physical activity, such as severe cardiac failure
  • participating in any type of Tai Ji Quan or daily and/or structured vigorous physical activity (i.e., brisk walking for exercise 30 minutes or longer at a time, or engaging in muscle-strengthening activities, e.g., weight lifting on 3 or more days per week 3 months prior to the study)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Research Institute

Eugene, Oregon, 97403, United States

Location

Related Publications (3)

  • Li F, Harmer P, Eckstrom E, Fitzgerald K, Winters-Stone K. Clinical Effectiveness of Cognitively Enhanced Tai Ji Quan Training on Global Cognition and Dual-Task Performance During Walking in Older Adults With Mild Cognitive Impairment or Self-Reported Memory Concerns : A Randomized Controlled Trial. Ann Intern Med. 2023 Nov;176(11):1498-1507. doi: 10.7326/M23-1603. Epub 2023 Oct 31.

    PMID: 37903365BACKGROUND
  • Li F, Harmer P, Eckstrom E, Winters-Stone K. Physical Activity Engagement After Tai Ji Quan Intervention Among Older Adults With Mild Cognitive Impairment or Memory Concerns: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Dec 2;7(12):e2450457. doi: 10.1001/jamanetworkopen.2024.50457.

  • Li F, Harmer P, Fitzgerald K, Winters-Stone K. A cognitively enhanced online Tai Ji Quan training intervention for community-dwelling older adults with mild cognitive impairment: A feasibility trial. BMC Geriatr. 2022 Jan 25;22(1):76. doi: 10.1186/s12877-021-02747-0.

Related Links

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

Limitations of the trial included (a) the lack of a nonexercise control group and (b) participants who were predominately White and well educated which limits the generalizability of these reports.

Results Point of Contact

Title
Fuzhong Li
Organization
Oregon Research Institute

Study Officials

  • Fuzhong Li, Ph.D.

    Oregon Research Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2019

First Posted

August 28, 2019

Study Start

October 15, 2019

Primary Completion

November 30, 2023

Study Completion

December 30, 2025

Last Updated

August 26, 2025

Results First Posted

August 26, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

The individual level data in this study will not be shared with others for reasons of confidentiality. However, a dataset with identifiable private information removed may be made available to other researchers.

Locations