Trial Outcomes & Findings for Tai Ji Quan and Cognitive Function in Older Adults With Mild Cognitive Impairment (NCT NCT04070703)

NCT ID: NCT04070703

Last Updated: 2025-08-26

Results Overview

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.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: NA
• Target enrollment: 318 participants
• Primary outcome timeframe: baseline, 6 months
• Results posted on: 2025-08-26

Participant Flow

Participant milestones

Measure	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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition	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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition	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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition
Overall Study STARTED	105	107	106
Overall Study COMPLETED	102	103	99
Overall Study NOT COMPLETED	3	4	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Cognitively Enhanced Tai Ji Quan n=105 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition	Standard Tai Ji Quan n=107 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition	Stretching n=106 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition	Total n=318 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	105 Participants n=5 Participants	107 Participants n=7 Participants	106 Participants n=5 Participants	318 Participants n=4 Participants
Age, Continuous	76 years STANDARD_DEVIATION 5 • n=5 Participants	76 years STANDARD_DEVIATION 5 • n=7 Participants	76 years STANDARD_DEVIATION 5 • n=5 Participants	76 years STANDARD_DEVIATION 5 • n=4 Participants
Sex: Female, Male Female	75 Participants n=5 Participants	66 Participants n=7 Participants	71 Participants n=5 Participants	212 Participants n=4 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	41 Participants n=7 Participants	35 Participants n=5 Participants	106 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	14 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	96 Participants n=5 Participants	90 Participants n=7 Participants	89 Participants n=5 Participants	275 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	11 Participants n=7 Participants	13 Participants n=5 Participants	29 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	8 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	7 Participants n=4 Participants
Race (NIH/OMB) White	96 Participants n=5 Participants	90 Participants n=7 Participants	89 Participants n=5 Participants	275 Participants n=4 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants	13 Participants n=7 Participants	9 Participants n=5 Participants	28 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	105 Participants n=5 Participants	107 Participants n=7 Participants	106 Participants n=5 Participants	318 Participants n=4 Participants

PRIMARY outcome

Timeframe: baseline, 6 months

Population: The primary outcome data were analyzed via a Group by Time mixed-effects model with repeated measures on the second factor (i.e., outcome measures assessed at baseline and 6 months. In the presence of a Group by Time interaction effect, pre-specified follow-up pair-wise comparisons were performed to determine between-group differences.

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.

Outcome measures

Measure	Cognitively Enhanced Tai Ji Quan n=105 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition	Standard Tai Ji Quan n=107 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition	Stretching n=106 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition
Montreal Cognitive Assessment Int Termination	28.4 points Standard Error .2	27 points Standard Error .2	25.6 points Standard Error .2
Montreal Cognitive Assessment Baseline	25.2 points Standard Error 0.2	25.3 points Standard Error 0.2	25.3 points Standard Error 0.2

PRIMARY outcome

Timeframe: baseline, 6 months

Population: The co-primary outcome data were analyzed via a Group by Time mixed-effects model with repeated measures on the second factor (i.e., outcome measures assessed at baseline and 6 months. In the presence of a Group by Time interaction effect, pre-specified follow-up pair-wise comparisons were performed to determine between-group differences.

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.

Outcome measures

Measure	Cognitively Enhanced Tai Ji Quan n=105 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition	Standard Tai Ji Quan n=107 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition	Stretching n=106 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition
Gait Performance Under a Dual-task Condition baseline	36.3 second Standard Error 2.3	36.3 second Standard Error 2.3	36.3 second Standard Error 2.4
Gait Performance Under a Dual-task Condition 6 months	15.5 second Standard Error 1.6	25.2 second Standard Error 1.5	37.5 second Standard Error 1.6

SECONDARY outcome

Timeframe: baseline, 6 months

Population: Analysis of variance examining difference between groups

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).

Outcome measures

Measure	Cognitively Enhanced Tai Ji Quan n=105 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition	Standard Tai Ji Quan n=107 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition	Stretching n=106 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition
Clinical Dementia Rating Scale baseline	1.0 points Standard Error .1	1.1 points Standard Error .1	1.1 points Standard Error .1
Clinical Dementia Rating Scale 6 months	.3 points Standard Error .1	.6 points Standard Error .1	.9 points Standard Error .1

SECONDARY outcome

Timeframe: baseline, 6 months

Population: Analysis of variance examining difference between groups.

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.

Outcome measures

Measure	Cognitively Enhanced Tai Ji Quan n=105 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition	Standard Tai Ji Quan n=107 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition	Stretching n=106 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition
Domain-specific Cognitive Test - Trail Making - B baseline	98.7 second Standard Error 1.6	98.4 second Standard Error 1.5	98 second Standard Error 1.6
Domain-specific Cognitive Test - Trail Making - B 6 months	72.4 second Standard Error 2.0	86.2 second Standard Error 2.0	94.2 second Standard Error 2.1

SECONDARY outcome

Timeframe: baseline, 6 months

Population: analysis of variance examining differences between groups.

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.

Outcome measures

Measure	Cognitively Enhanced Tai Ji Quan n=105 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition	Standard Tai Ji Quan n=107 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition	Stretching n=106 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition
4-Stage Balance Test baseline	2.6 points Standard Error .1	2.6 points Standard Error .1	2.6 points Standard Error .1
4-Stage Balance Test 6 months	3.4 points Standard Error .1	3.5 points Standard Error .1	2.6 points Standard Error .1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Cognitively Enhanced Tai Ji Quan n=105 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition	Standard Tai Ji Quan n=107 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition	Stretching n=106 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition
Backward Digit Span baseline	8.3 points Standard Deviation .2	8.4 points Standard Deviation .2	8.4 points Standard Deviation .2
Backward Digit Span 6 months	10.4 points Standard Deviation .2	9.4 points Standard Deviation .2	8.3 points Standard Deviation .2

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Cognitively Enhanced Tai Ji Quan n=105 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition	Standard Tai Ji Quan n=107 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition	Stretching n=106 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition
Verbal Fluency Test baseline	14 number of animals Standard Error .2	14 number of animals Standard Error .2	14 number of animals Standard Error .2
Verbal Fluency Test 6 months	19 number of animals Standard Error .3	19 number of animals Standard Error .3	15 number of animals Standard Error .3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Cognitively Enhanced Tai Ji Quan n=105 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition	Standard Tai Ji Quan n=107 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition	Stretching n=106 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition
Timed up and go baseline	12.6 seconds Standard Deviation .2	12.7 seconds Standard Deviation .2	12.5 seconds Standard Deviation .3
Timed up and go 6 months	10.8 seconds Standard Deviation .2	10.6 seconds Standard Deviation .2	12.6 seconds Standard Deviation .3

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Cognitively Enhanced Tai Ji Quan n=105 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition	Standard Tai Ji Quan n=107 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition	Stretching n=106 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition
30-Second Chair Stands Test baseline	11 chair stands Standard Error .2	11 chair stands Standard Error .2	11 chair stands Standard Error .3
30-Second Chair Stands Test 6 months	13 chair stands Standard Error .4	13 chair stands Standard Error .4	11 chair stands Standard Error .4

SECONDARY outcome

Timeframe: baseline, 6 months

Population: analysis of variance was conducted examining differences between groups

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.

Outcome measures

Measure	Cognitively Enhanced Tai Ji Quan n=105 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition	Standard Tai Ji Quan n=107 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition	Stretching n=106 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition
Forward Digit Span Test baseline	12.8 point Standard Error .1	10.6 point Standard Error .1	10.7 point Standard Error .1
Forward Digit Span Test 6 months	10.4 point Standard Error .2	9.4 point Standard Error .2	8.3 point Standard Error .2

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Cognitively Enhanced Tai Ji Quan n=105 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition	Standard Tai Ji Quan n=107 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition	Stretching n=106 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition
Sleep Quality - Pittsburgh Sleep Quality Index (PSQI) baseline	8.2 points Standard Deviation .3	8.3 points Standard Deviation .3	8.1 points Standard Deviation .3
Sleep Quality - Pittsburgh Sleep Quality Index (PSQI) 6 months	5.2 points Standard Deviation .3	5.2 points Standard Deviation .3	7.3 points Standard Deviation .3

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Cognitively Enhanced Tai Ji Quan n=105 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition	Standard Tai Ji Quan n=107 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition	Stretching n=106 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition
Depression - Geriatric Depression Scale (GDS) baseline	3.5 points Standard Deviation .3	3.4 points Standard Deviation .3	3.4 points Standard Deviation .3
Depression - Geriatric Depression Scale (GDS) 6 months	1.6 points Standard Deviation .2	1.2 points Standard Deviation .2	2.5 points Standard Deviation .2

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline, 6 months

Population: Analysis of variance was conducted to examine differences between groups

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.

Outcome measures

Measure	Cognitively Enhanced Tai Ji Quan n=105 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition	Standard Tai Ji Quan n=107 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition	Stretching n=106 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition
Activity and Movement Confidence Scales baseline	82 point Standard Deviation 1.3	82.6 point Standard Deviation 1.3	81.6 point Standard Deviation 1.3
Activity and Movement Confidence Scales 6 months	89.5 point Standard Deviation 1.3	88.3 point Standard Deviation 1.3	83.1 point Standard Deviation 1.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Cognitively Enhanced Tai Ji Quan n=105 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition	Standard Tai Ji Quan n=107 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition	Stretching n=106 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition
Quality of Life - EuroQol. baseline	.76 points Standard Deviation .01	.77 points Standard Deviation .01	.77 points Standard Deviation .01
Quality of Life - EuroQol. 6 months	.90 points Standard Deviation .01	.90 points Standard Deviation .01	.76 points Standard Deviation .01

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and 6 months

Population: Analysis of variance was conducted to examine differences between groups.

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.

Outcome measures

Measure	Cognitively Enhanced Tai Ji Quan n=105 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition	Standard Tai Ji Quan n=107 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition	Stretching n=106 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition
International Physical Activity Questionnaire (IPAQ) baseline	146 minutes Standard Error 12	145 minutes Standard Error 12	145.8 minutes Standard Error 12.3
International Physical Activity Questionnaire (IPAQ) 6 months	273 minutes Standard Error 12.5	267.9 minutes Standard Error 12	147.6 minutes Standard Error 12.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Cognitively Enhanced Tai Ji Quan n=105 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition	Standard Tai Ji Quan n=107 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition	Stretching n=106 Participants 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition
Everyday Cognition Scale baseline	2 points Standard Deviation .04	2 points Standard Deviation .04	2.1 points Standard Deviation .04
Everyday Cognition Scale 6 months	1.2 points Standard Deviation .1	1.4 points Standard Deviation .1	1.8 points Standard Deviation .1

Adverse Events

Cognitively Enhanced Tai Ji Quan

Serious events: 3 serious events

Other events: 10 other events

Deaths: 0 deaths

Standard Tai Ji Quan

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

Stretching

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cognitively Enhanced Tai Ji Quan n=105 participants at risk 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition	Standard Tai Ji Quan n=107 participants at risk 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition	Stretching n=106 participants at risk 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition
General disorders Serious event	2.9% 3/105 • Number of events 3 • Events were observed and documented during the 6-month active intervention period. Data reported in this record is consistent with the definitions described at clinicaltrials.gov	1.9% 2/107 • Number of events 2 • Events were observed and documented during the 6-month active intervention period. Data reported in this record is consistent with the definitions described at clinicaltrials.gov	1.9% 2/106 • Number of events 2 • Events were observed and documented during the 6-month active intervention period. Data reported in this record is consistent with the definitions described at clinicaltrials.gov

Other adverse events

Measure	Cognitively Enhanced Tai Ji Quan n=105 participants at risk 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition	Standard Tai Ji Quan n=107 participants at risk 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition	Stretching n=106 participants at risk 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. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition
Musculoskeletal and connective tissue disorders Other events	9.5% 10/105 • Number of events 10 • Events were observed and documented during the 6-month active intervention period. Data reported in this record is consistent with the definitions described at clinicaltrials.gov	9.3% 10/107 • Number of events 10 • Events were observed and documented during the 6-month active intervention period. Data reported in this record is consistent with the definitions described at clinicaltrials.gov	10.4% 11/106 • Number of events 11 • Events were observed and documented during the 6-month active intervention period. Data reported in this record is consistent with the definitions described at clinicaltrials.gov

Additional Information

Fuzhong Li

Oregon Research Institute

Phone: 5414842123

Email: fuzhongl@ori.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place