Tai Ji Quan and Cognitive Function in Older Adults With Mild Cognitive Impairment

April 1, 2024 updated by: Oregon Research Institute

Efficacy of Adapted Tai Ji Quan to Slow Cognitive Decline in Older Adults

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary aim of the study is to determine the efficacy of a cognitively enhanced exercise intervention - Tai Ji Quan: Moving to Maintain Brain Health, relative to a standard Tai Ji Quan intervention and an exercise stretching control, in improving global cognitive function and dual-task ability among community-dwelling older adults with amnestic mild cognitive impairment.

Study Type

Interventional

Enrollment (Actual)

332

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Eugene, Oregon, United States, 97403
        • Oregon Research Institute

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

65 years to 95 years (Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitively enhanced Tai Ji Quan
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
Exercise and Cognition
Active Comparator: Standard Tai Ji Quan
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
Exercise and Cognition
Sham Comparator: Stretching
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
Exercise and Cognition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montreal Cognitive Assessment
Time Frame: baseline, 6 months
Change in global cognitive function from baseline to 24 weeks
baseline, 6 months
gait under a dual-task condition - walking with no cognitive task, walking with a concurrent cognitive task
Time Frame: baseline, 6 months
Change in dual-task ability from baseline to 24 weeks
baseline, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Dementia Rating
Time Frame: baseline, 6 months
Change in cognitive decline from baseline to 24 weeks
baseline, 6 months
Paper-and-pencil domain-specific cognitive battery tests
Time Frame: baseline, 6 months
Change in domain-specific cognitive function from baseline to 24 weeks
baseline, 6 months
Computerized cognitive battery tests
Time Frame: baseline, 6 months
Change in domain-specific cognitive function from baseline to 24 weeks
baseline, 6 months
Physical performance - Functional Reach; Short Physical Performance Battery
Time Frame: baseline, 6 months
Change in physical performance from baseline to 24 weeks
baseline, 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep quality - Pittsburgh Sleep Quality Index (PSQI)
Time Frame: baseline, 6 months
Change in sleep quality from baseline to 24 weeks. The PSQI total score ranges from 0 to 21 points, with high scores indicating poorer sleep quality.
baseline, 6 months
Depression - Geriatric Depression Scale (GDS)
Time Frame: baseline, 6 months
Change in depression from baseline to 24 weeks. The GDS score ranges from 0 to 15 with scores higher than 5 indicative of depression.
baseline, 6 months
Activity and movement confidence scales
Time Frame: baseline, 6 months
Change in activity and movement confidence from baseline to 24 weeks. The total score ranges from 0 to 10 with high scores indicating high confidence.
baseline, 6 months
Quality of life - EuroQol.
Time Frame: baseline, 6 months
Change in quality of life from baseline to 24 weeks. The EQ-5D-3L version will be used that comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The scores of EQ-5D-3L will be combined to generate a single utility value ranging from 1.00 for the "best health" state to -0.594 for the "worst health" state, where a score of 0 is indicative of death, and scores less than 0 are considered as "worse than death." Participants who die during the trial period will be registered as 0 in utility terms for the assessment period from when the death occurred.
baseline, 6 months
Physical activity - International Physical Activity Questionnaire (IPAQ)
Time Frame: baseline.
Level of physical activity. IPAQ measures physical activity by self-report over the previous 7 days with levels of activities classified into low, moderate, or high. The results in this study will be presented in MET minutes a week with high values indicating high amount of energy expended carrying out physical activity.
baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Research Institute

Investigators

  • Principal Investigator: Fuzhong Li, Ph.D., Oregon Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

October 15, 2019

Primary Completion (Actual)

November 30, 2023

Study Completion (Estimated)

May 28, 2024

Study Registration Dates

First Submitted

August 26, 2019

First Submitted That Met QC Criteria

August 26, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AG059546

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

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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