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

• ClinicalTrials.gov Identifier: NCT04070703
• Recruitment Status: Active, not recruiting
• First Posted: August 28, 2019
• Last Update Posted: February 8, 2023
• Sponsor: Oregon Research Institute
• Information provided by (Responsible Party): Oregon Research Institute

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.

Condition or disease	Intervention/treatment	Phase
Mild Cognitive Impairment	Behavioral: The Go for Exercise & Healthy Aging Project	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 332 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Efficacy of Adapted Tai Ji Quan to Slow Cognitive Decline in Older Adults
• Actual Study Start Date: October 15, 2019
• Estimated Primary Completion Date: November 30, 2023
• Estimated Study Completion Date: February 28, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Montreal Cognitive Assessment [ Time Frame: baseline, 6 months ]
   Change in global cognitive function from baseline to 24 weeks
2. 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

Secondary Outcome Measures :

1. Clinical Dementia Rating [ Time Frame: baseline, 6 months ]
   Change in cognitive decline from baseline to 24 weeks
2. Paper-and-pencil domain-specific cognitive battery tests [ Time Frame: baseline, 6 months ]
   Change in domain-specific cognitive function from baseline to 24 weeks
3. Computerized cognitive battery tests [ Time Frame: baseline, 6 months ]
   Change in domain-specific cognitive function from baseline to 24 weeks
4. Physical performance - Functional Reach; Short Physical Performance Battery [ Time Frame: baseline, 6 months ]
   Change in physical performance from baseline to 24 weeks

Other Outcome Measures:

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.

Eligibility Criteria

• Ages Eligible for Study: 65 Years to 95 Years (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

United States, Oregon

Oregon Research Institute

Eugene, Oregon, United States, 97403

Sponsors and Collaborators

Oregon Research Institute

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Oregon Research Institute
• ClinicalTrials.gov Identifier: NCT04070703
• Other Study ID Numbers: AG059546
• First Posted: August 28, 2019
• Last Update Posted: February 8, 2023
• Last Verified: February 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Oregon Research Institute:

Cognitive function; mild cognitive impairment; Tai Ji Quan

Additional relevant MeSH terms:

Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders