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

Primary Purpose

Mild Cognitive Impairment

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

The Go for Exercise & Healthy Aging Project

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring Cognitive function, mild cognitive impairment, Tai Ji Quan

Eligibility Criteria

65 Years - 95 Years (Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

Oregon Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

Cognitively enhanced Tai Ji Quan

Standard Tai Ji Quan

Stretching

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Montreal Cognitive Assessment

Change in global cognitive function from baseline to 24 weeks

gait under a dual-task condition - walking with no cognitive task, walking with a concurrent cognitive task

Change in dual-task ability from baseline to 24 weeks

Secondary Outcome Measures

Clinical Dementia Rating

Change in cognitive decline from baseline to 24 weeks

Paper-and-pencil domain-specific cognitive battery tests

Change in domain-specific cognitive function from baseline to 24 weeks

Computerized cognitive battery tests

Change in domain-specific cognitive function from baseline to 24 weeks

Physical performance - Functional Reach; Short Physical Performance Battery

Change in physical performance from baseline to 24 weeks

Full Information

NCT ID

NCT04070703

First Posted

August 26, 2019

Last Updated

March 21, 2023

Sponsor

Oregon Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT04070703

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 15, 2019 (Actual)

Primary Completion Date

November 30, 2023 (Anticipated)

Study Completion Date

February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Oregon Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Cognitive Impairment

Keywords

Cognitive function, mild cognitive impairment, Tai Ji Quan

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

332 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cognitively enhanced Tai Ji Quan

Arm Type

Experimental

Arm Description

Arm Title

Standard Tai Ji Quan

Arm Type

Active Comparator

Arm Description

Arm Title

Stretching

Arm Type

Sham Comparator

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

The Go for Exercise & Healthy Aging Project

Intervention Description

Exercise and Cognition

Primary Outcome Measure Information:

Title

Montreal Cognitive Assessment

Description

Change in global cognitive function from baseline to 24 weeks

Time Frame

baseline, 6 months

Title

gait under a dual-task condition - walking with no cognitive task, walking with a concurrent cognitive task

Description

Change in dual-task ability from baseline to 24 weeks

Time Frame

baseline, 6 months

Secondary Outcome Measure Information:

Title

Clinical Dementia Rating

Description

Change in cognitive decline from baseline to 24 weeks

Time Frame

baseline, 6 months

Title

Paper-and-pencil domain-specific cognitive battery tests

Description

Change in domain-specific cognitive function from baseline to 24 weeks

Time Frame

baseline, 6 months

Title

Computerized cognitive battery tests

Description

Change in domain-specific cognitive function from baseline to 24 weeks

Time Frame

baseline, 6 months

Title

Physical performance - Functional Reach; Short Physical Performance Battery

Description

Change in physical performance from baseline to 24 weeks

Time Frame

baseline, 6 months

Other Pre-specified Outcome Measures:

Title

Sleep quality - Pittsburgh Sleep Quality Index (PSQI)

Description

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.

Time Frame

baseline, 6 months

Title

Depression - Geriatric Depression Scale (GDS)

Description

Change in depression from baseline to 24 weeks. The GDS score ranges from 0 to 15 with scores higher than 5 indicative of depression.

Time Frame

baseline, 6 months

Title

Activity and movement confidence scales

Description

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.

Time Frame

baseline, 6 months

Title

Quality of life - EuroQol.

Description

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.

Time Frame

baseline, 6 months

Title

Physical activity - International Physical Activity Questionnaire (IPAQ)

Description

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.

Time Frame

baseline.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Maximum Age & Unit of Time

95 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fuzhong Li, Ph.D.

Organizational Affiliation

Oregon Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Oregon Research Institute

City

Eugene

State/Province

Oregon

ZIP/Postal Code

97403

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing 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.

Citations:

PubMed Identifier

35078407

Citation

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.

Results Reference

derived

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

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