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

NCT04070703 — Not applicable, Completed, 318 participants, Oregon Research Institute

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

RegistryNCT04070703
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, prevention
Enrollment318 (Actual)
SponsorOregon Research Institute (Other)
ConditionsMild Cognitive Impairment
InterventionsThe Go for Exercise & Healthy Aging Project (Behavioral)
Datesstart 2019-10-15, primary completion 2023-11-30, completion 2025-12-30, first posted 2019-08-28, last updated 2026-07-30
Locations1 site in United States

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Cognitively enhanced Tai Ji QuanExperimentalBehavioral: The Go for Exercise & Healthy Aging ProjectParticipants 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.
Standard Tai Ji QuanActive comparatorBehavioral: The Go for Exercise & Healthy Aging ProjectServing 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.
StretchingSham comparatorBehavioral: The Go for Exercise & Healthy Aging ProjectServing as a control arm, participants in this intervention will engage in a series of light exercise activities consisting of breathing, stretching, and body relaxation.
  • The Go for Exercise & Healthy Aging Project (Behavioral): Exercise and Cognition

+Outcome measures

Primary outcomes

  • Montreal Cognitive Assessment [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.
  • Gait Performance Under a Dual-task Condition [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

  • Clinical Dementia Rating Scale [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).
  • Domain-specific Cognitive Test - Trail Making - B [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.
  • 4-Stage Balance Test [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.
  • Backward Digit Span [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.
  • Verbal Fluency Test [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).
  • Timed up and go [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.
  • 30-Second Chair Stands Test [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).
  • Forward Digit Span Test [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

  • Sleep Quality - Pittsburgh Sleep Quality Index (PSQI) [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.
  • Depression - Geriatric Depression Scale (GDS) [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.
  • Activity and Movement Confidence Scales [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.
  • Quality of Life - EuroQol. [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.
  • International Physical Activity Questionnaire (IPAQ) [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.
  • Everyday Cognition Scale [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.

+Eligibility

Sex: All, ages: 65 Years to 95 Years, accepts 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)

+Posted results

Participant flow

MilestoneCognitively Enhanced Tai Ji QuanStandard Tai Ji QuanStretching
Started105107106
Completed10210399
Not completed347

Outcome results

  • Montreal Cognitive Assessment (Primary), Mean, points: Cognitively Enhanced Tai Ji Quan 25.2 +/- 0.2; Standard Tai Ji Quan 25.3 +/- 0.2; Stretching 25.3 +/- 0.2 (p 0.0125)
  • Gait Performance Under a Dual-task Condition (Primary), Mean, second: Cognitively Enhanced Tai Ji Quan 36.3 +/- 2.3; Standard Tai Ji Quan 36.3 +/- 2.3; Stretching 36.3 +/- 2.4 (p .0125)
  • Clinical Dementia Rating Scale (Secondary), Mean, points: Cognitively Enhanced Tai Ji Quan 1.0 +/- .1; Standard Tai Ji Quan 1.1 +/- .1; Stretching 1.1 +/- .1 (p 0.05)
  • Domain-specific Cognitive Test - Trail Making - B (Secondary), Mean, second: Cognitively Enhanced Tai Ji Quan 98.7 +/- 1.6; Standard Tai Ji Quan 98.4 +/- 1.5; Stretching 98 +/- 1.6 (p .05)
  • 4-Stage Balance Test (Secondary), Mean, points: Cognitively Enhanced Tai Ji Quan 2.6 +/- .1; Standard Tai Ji Quan 2.6 +/- .1; Stretching 2.6 +/- .1 (p <.05)
  • Backward Digit Span (Secondary), Mean, points: Cognitively Enhanced Tai Ji Quan 8.3 +/- .2; Standard Tai Ji Quan 8.4 +/- .2; Stretching 8.4 +/- .2 (p <.05)
  • Verbal Fluency Test (Secondary), Mean, number of animals: Cognitively Enhanced Tai Ji Quan 14 +/- .2; Standard Tai Ji Quan 14 +/- .2; Stretching 14 +/- .2 (p <.05)
  • Timed up and go (Secondary), Mean, seconds: Cognitively Enhanced Tai Ji Quan 12.6 +/- .2; Standard Tai Ji Quan 12.7 +/- .2; Stretching 12.5 +/- .3 (p <.05)
  • 30-Second Chair Stands Test (Secondary), Mean, chair stands: Cognitively Enhanced Tai Ji Quan 11 +/- .2; Standard Tai Ji Quan 11 +/- .2; Stretching 11 +/- .3 (p <.05)
  • Forward Digit Span Test (Secondary), Mean, point: Cognitively Enhanced Tai Ji Quan 12.8 +/- .1; Standard Tai Ji Quan 10.6 +/- .1; Stretching 10.7 +/- .1 (p <.05)
  • Sleep Quality - Pittsburgh Sleep Quality Index (PSQI) (Other pre specified), Mean, points: Cognitively Enhanced Tai Ji Quan 8.2 +/- .3; Standard Tai Ji Quan 8.3 +/- .3; Stretching 8.1 +/- .3 (p <.05)
  • Depression - Geriatric Depression Scale (GDS) (Other pre specified), Mean, points: Cognitively Enhanced Tai Ji Quan 3.5 +/- .3; Standard Tai Ji Quan 3.4 +/- .3; Stretching 3.4 +/- .3 (p <.05)
  • Activity and Movement Confidence Scales (Other pre specified), Mean, point: Cognitively Enhanced Tai Ji Quan 82 +/- 1.3; Standard Tai Ji Quan 82.6 +/- 1.3; Stretching 81.6 +/- 1.3 (p <.05)
  • Quality of Life - EuroQol. (Other pre specified), Mean, points: Cognitively Enhanced Tai Ji Quan .76 +/- .01; Standard Tai Ji Quan .77 +/- .01; Stretching .77 +/- .01 (p <.05)
  • International Physical Activity Questionnaire (IPAQ) (Other pre specified), Mean, minutes: Cognitively Enhanced Tai Ji Quan 146 +/- 12; Standard Tai Ji Quan 145 +/- 12; Stretching 145.8 +/- 12.3 (p <.05)
  • Everyday Cognition Scale (Other pre specified), Mean, points: Cognitively Enhanced Tai Ji Quan 2 +/- .04; Standard Tai Ji Quan 2 +/- .04; Stretching 2.1 +/- .04 (p <.05)

Adverse events

Time frame: Events were observed and documented during the 6-month active intervention period.

ArmDeathsSerious adverse eventsOther adverse events
Cognitively Enhanced Tai Ji Quan0/105 (0.0%)3/105 (2.9%)10/105 (9.5%)
Standard Tai Ji Quan0/107 (0.0%)2/107 (1.9%)10/107 (9.3%)
Stretching0/106 (0.0%)2/106 (1.9%)11/106 (10.4%)

Serious adverse events by term

TermOrgan systemCognitively Enhanced Tai Ji QuanStandard Tai Ji QuanStretching
Serious eventGeneral disorders3/1052/1072/106

Other adverse events by term

TermOrgan systemCognitively Enhanced Tai Ji QuanStandard Tai Ji QuanStretching
Other eventsMusculoskeletal and connective tissue disorders10/10510/10711/106

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.

+Locations (1)

FacilityCityCountryStatus
Oregon Research InstituteEugene, OregonUnited States

+Publications

  • 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 37903365
  • Results publication: 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. PMID 39688866
  • Results publication: 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. PMID 35078407

+Study documents

+Investigators

My Notes