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Completed

NCT Number: NCT04070703

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

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.

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Key information

Age range

65 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Research Institute

Eugene, Oregon, 97403, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

The Go for Exercise & Healthy Aging Project

Behavioral

Exercise and Cognition

Primary outcomes

  1. Montreal Cognitive Assessment

    Time frame: baseline, 6 months

    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.

  2. Gait Performance Under a Dual-task Condition

    Time frame: baseline, 6 months

    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.

Secondary outcomes

  1. Clinical Dementia Rating Scale

    Time frame: baseline, 6 months

    The Clinical Dementia Rating Scale measures change in cognitive decline from baseline to 6 months. The scale measures six domains of cognitive and functional performance. Scores range from 0 to 3 points in each domain, with a score of 0 indicating no impairment, while a score of 3 signifying severe impairment. Scores from all domains have been averaged to compute the total score reported. In this trial, lower scores indicate less severity in cognitive decline (i.e., improvement from intervention).

  2. Domain-specific Cognitive Test - Trail Making - B

    Time frame: baseline, 6 months

    Change in domain-specific cognitive function - executive function (measured in seconds) from baseline to 24 weeks. Trail Making Test assesses attention and executive function. In this test, the participant connects numbers and letters in an alternating progressive sequence, 1 to A, 2 to B, 3 to C, and so on. For parts A and B, scoring is expressed in terms of the time (in seconds) to completion. Lower scores indicate higher executive functioning.

  3. 4-Stage Balance Test

    Time frame: baseline, 6 months

    The 4-Stage Balance Test measures change, from baseline to 6 months, in standing four positions balance. Participants attempt to hold four progressively challenging standing positions. The test ends if a position cannot be held for 10 seconds. The number of positions successfully completed is recorded and awarded one point (0-4), with higher score values indicating better balance.

  4. Backward Digit Span

    Time frame: baseline, 6 months

    The Backward Digit Span test assesses memory. The participant is verbally presented with a series of digits (e.g., 6, 2, 9, 7) at a rate of one digit per second and is required to repeat them verbatim. If the participant succeeds, he/she is given a longer list (e.g., 5, 3, 8, 1, 6). The number of digits increases by one until the participant consecutively fails two trials of the same digit span length. The length of the longest list a person can remember is that person's digit span. In this test, the participant is required to repeat the digits in reverse. The participant receives 1 point for each correct answer. The Backward Digit Span test scores range from 0 to 32, with higher scores indicating better memory.

  5. Verbal Fluency Test

    Time frame: baseline, 6 months

    The Verbal Fluency Test assesses verbal fluency and executive function of cognitive function. The participant is asked to generate the names of as many animals as possible in 60 seconds. High scores (i.e., more animals names generated) in this measure indicate better performance (i.e., better verbal fluency and executive function).

  6. Timed up and go

    Time frame: baseline, 6 months

    The Timed up and go (TUG) measure is recorded in seconds (the time taken by an individual to stand up from a standard armless chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down). Lower scores indicate better performance.

  7. 30-Second Chair Stands Test

    Time frame: baseline, 6 months

    The 30-Second Chair Stands Test is used to measure change from baseline to 6 months in physical performance. The Test involves repeatedly standing up from and sitting down in a chair as many times as possible within 30 seconds, with high (count) scores indicating better performance (i.e., leg strength).

  8. Forward Digit Span Test

    Time frame: baseline, 6 months

    The Forward Digit Span test measures attention/concentration (in points) with high scores indicating better attention. The participant is verbally presented with a series of digits (e.g., 6, 2, 9, 7) at a rate of one digit per second and is required to repeat them verbatim. If the participant succeeds, he/she is given a longer list (e.g., 5, 3, 8, 1, 6). The number of digits increases by one until the participant consecutively fails two trials of the same digit span length. The length of the longest list a person can remember is that person's digit span.

Other outcomes

  1. Sleep Quality - Pittsburgh Sleep Quality Index (PSQI)

    Time frame: baseline, 6 months

    Change in sleep quality from baseline to 24 weeks. The Pittsburgh Sleep Quality Index (PSQI) includes seven indices: subjective quality, latency (i.e., time needed to fall asleep), duration (i.e., number of hours of actual sleep per night), efficiency (i.e., total sleep time divided by time in bed, converted to a score of 0-3), sleep disturbances (e.g., waking up in the middle of the night and the like), use of sleeping medication, and daytime dysfunction (e.g., having difficulty staying awake during the day). Each of the component scores ranges from 0 to 3, with the PSQI global score ranging from 0 to 21 points, with higher 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 Geriatric Depression Scale (GDS) score ranges from 0 to 15 with higher scores indicated increased depression symptoms and scores higher than 5 indicative of depression.

  3. Activity and Movement Confidence Scales

    Time frame: baseline, 6 months

    The Activity and Movement Confidence Scales measure a person's movement confidence. In this study it assesses change in activity and movement confidence from baseline to 24 weeks. The total score ranges from 0 to 100 with higher scores indicating higher confidence.

  4. Quality of Life - EuroQol.

    Time frame: baseline, 6 months

    The Quality of Life - EuroQol. scale assesses quality of life. 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 averaged 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. International Physical Activity Questionnaire (IPAQ)

    Time frame: baseline and 6 months

    The International Physical Activity Questionnaire (IPAQ) measures the level of moderate and vigorous physical activity (MVPA) (measured in minutes) with high scores indicating high level of physical activity. This measure asks participants to report how often (measured in days) and how much time (in minutes) over the previous week they participated in physical activity or exercise of any moderate (ex. gardening, cleaning, etc.) or vigorous (ex. heavy lifting, jogging/running or fast bicycling, etc.) intensity that lasted at least 10 minutes at a time. The activities to be asked during the post-intervention follow-up (at 6 months) will not include the time spent in attending the assigned exercise programs in the study. Total weekly duration of MVPA, measured in minutes, are calculated by multiplying frequency and duration (vigorous activity weighted by 2) to form a total weighted amount of MVPA min/week.

  6. Everyday Cognition Scale

    Time frame: baseline, 6 months

    The Everyday Cognition Scale measures change from baseline to 6 months in everyday cognitive function. Sub scale scores will be averaged to create a total score. Total scores range 1 to 4, with higher scores indicating better everyday cognitive function.

Sponsors and collaborators

Lead sponsor

Oregon Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2025
First posted
Aug 28, 2019
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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