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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04070703
Enrollment
318
Registered
2019-08-28
Start date
2019-10-15
Completion date
2025-12-30
Last updated
2026-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment

Keywords

Cognitive function, mild cognitive impairment, Tai Ji Quan

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.

Interventions

BEHAVIORALThe Go for Exercise & Healthy Aging Project

Exercise and Cognition

Sponsors

Oregon Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to 95 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Montreal Cognitive Assessmentbaseline, 6 monthsThe 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 Conditionbaseline, 6 monthsAssessing 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

MeasureTime frameDescription
Clinical Dementia Rating Scalebaseline, 6 monthsThe 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 - Bbaseline, 6 monthsChange 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 Testbaseline, 6 monthsThe 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 Spanbaseline, 6 monthsThe 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 Testbaseline, 6 monthsThe 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 gobaseline, 6 monthsThe 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 Testbaseline, 6 monthsThe 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 Testbaseline, 6 monthsThe 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORFuzhong Li, Ph.D.

Oregon Research Institute

Participant flow

Participants by arm

ArmCount
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
105
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
107
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
106
Total318

Baseline characteristics

CharacteristicCognitively Enhanced Tai Ji QuanStandard Tai Ji QuanStretchingTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
105 Participants107 Participants106 Participants318 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants0 Participants
Age, Continuous76 years
STANDARD_DEVIATION 5
76 years
STANDARD_DEVIATION 5
76 years
STANDARD_DEVIATION 5
76 years
STANDARD_DEVIATION 5
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants6 Participants4 Participants14 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
96 Participants90 Participants89 Participants275 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
5 Participants11 Participants13 Participants29 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants3 Participants4 Participants8 Participants
Race (NIH/OMB)
Black or African American
2 Participants1 Participants4 Participants7 Participants
Race (NIH/OMB)
More than one race
6 Participants13 Participants9 Participants28 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
96 Participants90 Participants89 Participants275 Participants
Region of Enrollment
United States
105 Participants107 Participants106 Participants318 Participants
Sex: Female, Male
Female
75 Participants66 Participants71 Participants212 Participants
Sex: Female, Male
Male
30 Participants41 Participants35 Participants106 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 1050 / 1070 / 106
other
Total, other adverse events
10 / 10510 / 10711 / 106
serious
Total, serious adverse events
3 / 1052 / 1072 / 106

Outcome results

Primary

Gait Performance Under a Dual-task Condition

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.

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Cognitively Enhanced Tai Ji QuanGait Performance Under a Dual-task Conditionbaseline36.3 secondStandard Error 2.3
Cognitively Enhanced Tai Ji QuanGait Performance Under a Dual-task Condition6 months15.5 secondStandard Error 1.6
Standard Tai Ji QuanGait Performance Under a Dual-task Conditionbaseline36.3 secondStandard Error 2.3
Standard Tai Ji QuanGait Performance Under a Dual-task Condition6 months25.2 secondStandard Error 1.5
StretchingGait Performance Under a Dual-task Conditionbaseline36.3 secondStandard Error 2.4
StretchingGait Performance Under a Dual-task Condition6 months37.5 secondStandard Error 1.6
p-value: 0.012598.75% CI: [2.8, 16.6]Mixed Models Analysis
p-value: 0.012598.75% CI: [12.6, 31.2]Mixed Models Analysis
Primary

Montreal Cognitive Assessment

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.

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Cognitively Enhanced Tai Ji QuanMontreal Cognitive AssessmentBaseline25.2 pointsStandard Error 0.2
Cognitively Enhanced Tai Ji QuanMontreal Cognitive AssessmentInt Termination28.4 pointsStandard Error 0.2
Standard Tai Ji QuanMontreal Cognitive AssessmentBaseline25.3 pointsStandard Error 0.2
Standard Tai Ji QuanMontreal Cognitive AssessmentInt Termination27 pointsStandard Error 0.2
StretchingMontreal Cognitive AssessmentBaseline25.3 pointsStandard Error 0.2
StretchingMontreal Cognitive AssessmentInt Termination25.6 pointsStandard Error 0.2
p-value: 0.012598.75% CI: [2.1, 3.6]Mixed Models Analysis
p-value: 0.012598.75% CI: [0.07, 2.2]Mixed Models Analysis
Secondary

30-Second Chair Stands Test

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).

Time frame: baseline, 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Cognitively Enhanced Tai Ji Quan30-Second Chair Stands Test6 months13 chair standsStandard Error 0.4
Cognitively Enhanced Tai Ji Quan30-Second Chair Stands Testbaseline11 chair standsStandard Error 0.2
Standard Tai Ji Quan30-Second Chair Stands Testbaseline11 chair standsStandard Error 0.2
Standard Tai Ji Quan30-Second Chair Stands Test6 months13 chair standsStandard Error 0.4
Stretching30-Second Chair Stands Testbaseline11 chair standsStandard Error 0.3
Stretching30-Second Chair Stands Test6 months11 chair standsStandard Error 0.4
p-value: <0.0595% CI: [-1.4, 0.4]Mixed Models Analysis
p-value: <0.0595% CI: [0.8, 2.3]Mixed Models Analysis
Secondary

4-Stage Balance Test

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.

Time frame: baseline, 6 months

Population: analysis of variance examining differences between groups.

ArmMeasureGroupValue (MEAN)Dispersion
Cognitively Enhanced Tai Ji Quan4-Stage Balance Testbaseline2.6 pointsStandard Error 0.1
Cognitively Enhanced Tai Ji Quan4-Stage Balance Test6 months3.4 pointsStandard Error 0.1
Standard Tai Ji Quan4-Stage Balance Testbaseline2.6 pointsStandard Error 0.1
Standard Tai Ji Quan4-Stage Balance Test6 months3.5 pointsStandard Error 0.1
Stretching4-Stage Balance Testbaseline2.6 pointsStandard Error 0.1
Stretching4-Stage Balance Test6 months2.6 pointsStandard Error 0.1
p-value: <0.0595% CI: [-0.4, 0.1]Mixed Models Analysis
p-value: <0.0595% CI: [0.4, 1.2]Mixed Models Analysis
Secondary

Backward Digit Span

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.

Time frame: baseline, 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Cognitively Enhanced Tai Ji QuanBackward Digit Spanbaseline8.3 pointsStandard Deviation 0.2
Cognitively Enhanced Tai Ji QuanBackward Digit Span6 months10.4 pointsStandard Deviation 0.2
Standard Tai Ji QuanBackward Digit Spanbaseline8.4 pointsStandard Deviation 0.2
Standard Tai Ji QuanBackward Digit Span6 months9.4 pointsStandard Deviation 0.2
StretchingBackward Digit Spanbaseline8.4 pointsStandard Deviation 0.2
StretchingBackward Digit Span6 months8.3 pointsStandard Deviation 0.2
p-value: <0.0595% CI: [0.5, 1.6]Mixed Models Analysis
p-value: <0.0595% CI: [1.6, 2.7]Mixed Models Analysis
Secondary

Clinical Dementia Rating Scale

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).

Time frame: baseline, 6 months

Population: Analysis of variance examining difference between groups

ArmMeasureGroupValue (MEAN)Dispersion
Cognitively Enhanced Tai Ji QuanClinical Dementia Rating Scale6 months.3 pointsStandard Error 0.1
Cognitively Enhanced Tai Ji QuanClinical Dementia Rating Scalebaseline1.0 pointsStandard Error 0.1
Standard Tai Ji QuanClinical Dementia Rating Scale6 months.6 pointsStandard Error 0.1
Standard Tai Ji QuanClinical Dementia Rating Scalebaseline1.1 pointsStandard Error 0.1
StretchingClinical Dementia Rating Scalebaseline1.1 pointsStandard Error 0.1
StretchingClinical Dementia Rating Scale6 months.9 pointsStandard Error 0.1
p-value: 0.0595% CI: [-0.5, -0.1]Mixed Models Analysis
p-value: 0.0595% CI: [-0.7, -0.3]Mixed Models Analysis
Secondary

Domain-specific Cognitive Test - Trail Making - B

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.

Time frame: baseline, 6 months

Population: Analysis of variance examining difference between groups.

ArmMeasureGroupValue (MEAN)Dispersion
Cognitively Enhanced Tai Ji QuanDomain-specific Cognitive Test - Trail Making - Bbaseline98.7 secondStandard Error 1.6
Cognitively Enhanced Tai Ji QuanDomain-specific Cognitive Test - Trail Making - B6 months72.4 secondStandard Error 2
Standard Tai Ji QuanDomain-specific Cognitive Test - Trail Making - B6 months86.2 secondStandard Error 2
Standard Tai Ji QuanDomain-specific Cognitive Test - Trail Making - Bbaseline98.4 secondStandard Error 1.5
StretchingDomain-specific Cognitive Test - Trail Making - Bbaseline98 secondStandard Error 1.6
StretchingDomain-specific Cognitive Test - Trail Making - B6 months94.2 secondStandard Error 2.1
p-value: 0.0595% CI: [-20, -8]Mixed Models Analysis
p-value: 0.0595% CI: [-28, -16]Mixed Models Analysis
Secondary

Forward Digit Span Test

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.

Time frame: baseline, 6 months

Population: analysis of variance was conducted examining differences between groups

ArmMeasureGroupValue (MEAN)Dispersion
Cognitively Enhanced Tai Ji QuanForward Digit Span Testbaseline12.8 pointStandard Error 0.1
Cognitively Enhanced Tai Ji QuanForward Digit Span Test6 months10.4 pointStandard Error 0.2
Standard Tai Ji QuanForward Digit Span Testbaseline10.6 pointStandard Error 0.1
Standard Tai Ji QuanForward Digit Span Test6 months9.4 pointStandard Error 0.2
StretchingForward Digit Span Test6 months8.3 pointStandard Error 0.2
StretchingForward Digit Span Testbaseline10.7 pointStandard Error 0.1
p-value: <0.0595% CI: [-0.1, 1.1]Mixed Models Analysis
p-value: <0.0595% CI: [1.6, 2.8]Mixed Models Analysis
Secondary

Timed up and go

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.

Time frame: baseline, 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Cognitively Enhanced Tai Ji QuanTimed up and gobaseline12.6 secondsStandard Deviation 0.2
Cognitively Enhanced Tai Ji QuanTimed up and go6 months10.8 secondsStandard Deviation 0.2
Standard Tai Ji QuanTimed up and gobaseline12.7 secondsStandard Deviation 0.2
Standard Tai Ji QuanTimed up and go6 months10.6 secondsStandard Deviation 0.2
StretchingTimed up and gobaseline12.5 secondsStandard Deviation 0.3
StretchingTimed up and go6 months12.6 secondsStandard Deviation 0.3
p-value: <0.0595% CI: [-0.3, 0.7]Mixed Models Analysis
p-value: <0.0595% CI: [-2.4, -1.4]Mixed Models Analysis
Secondary

Verbal Fluency Test

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).

Time frame: baseline, 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Cognitively Enhanced Tai Ji QuanVerbal Fluency Testbaseline14 number of animalsStandard Error 0.2
Cognitively Enhanced Tai Ji QuanVerbal Fluency Test6 months19 number of animalsStandard Error 0.3
Standard Tai Ji QuanVerbal Fluency Testbaseline14 number of animalsStandard Error 0.2
Standard Tai Ji QuanVerbal Fluency Test6 months19 number of animalsStandard Error 0.3
StretchingVerbal Fluency Testbaseline14 number of animalsStandard Error 0.2
StretchingVerbal Fluency Test6 months15 number of animalsStandard Error 0.3
p-value: <0.0595% CI: [-0.4, 2.1]Mixed Models Analysis
p-value: <0.0595% CI: [3.1, 5]Mixed Models Analysis
Other Pre-specified

Activity and Movement Confidence Scales

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.

Time frame: baseline, 6 months

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

ArmMeasureGroupValue (MEAN)Dispersion
Cognitively Enhanced Tai Ji QuanActivity and Movement Confidence Scalesbaseline82 pointStandard Deviation 1.3
Cognitively Enhanced Tai Ji QuanActivity and Movement Confidence Scales6 months89.5 pointStandard Deviation 1.3
Standard Tai Ji QuanActivity and Movement Confidence Scalesbaseline82.6 pointStandard Deviation 1.3
Standard Tai Ji QuanActivity and Movement Confidence Scales6 months88.3 pointStandard Deviation 1.3
StretchingActivity and Movement Confidence Scalesbaseline81.6 pointStandard Deviation 1.3
StretchingActivity and Movement Confidence Scales6 months83.1 pointStandard Deviation 1.3
p-value: <0.0595% CI: [-0.4, 2]Mixed Models Analysis
p-value: <0.0595% CI: [3.1, 7.9]Mixed Models Analysis
Other Pre-specified

Depression - Geriatric Depression Scale (GDS)

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.

Time frame: baseline, 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Cognitively Enhanced Tai Ji QuanDepression - Geriatric Depression Scale (GDS)baseline3.5 pointsStandard Deviation 0.3
Cognitively Enhanced Tai Ji QuanDepression - Geriatric Depression Scale (GDS)6 months1.6 pointsStandard Deviation 0.2
Standard Tai Ji QuanDepression - Geriatric Depression Scale (GDS)baseline3.4 pointsStandard Deviation 0.3
Standard Tai Ji QuanDepression - Geriatric Depression Scale (GDS)6 months1.2 pointsStandard Deviation 0.2
StretchingDepression - Geriatric Depression Scale (GDS)baseline3.4 pointsStandard Deviation 0.3
StretchingDepression - Geriatric Depression Scale (GDS)6 months2.5 pointsStandard Deviation 0.2
p-value: <0.0595% CI: [-0.3, 1.2]Mixed Models Analysis
p-value: <0.0595% CI: [-1.8, -0.2]Mixed Models Analysis
Other Pre-specified

Everyday Cognition Scale

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.

Time frame: baseline, 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Cognitively Enhanced Tai Ji QuanEveryday Cognition Scalebaseline2 pointsStandard Deviation 0.04
Cognitively Enhanced Tai Ji QuanEveryday Cognition Scale6 months1.2 pointsStandard Deviation 0.1
Standard Tai Ji QuanEveryday Cognition Scalebaseline2 pointsStandard Deviation 0.04
Standard Tai Ji QuanEveryday Cognition Scale6 months1.4 pointsStandard Deviation 0.1
StretchingEveryday Cognition Scalebaseline2.1 pointsStandard Deviation 0.04
StretchingEveryday Cognition Scale6 months1.8 pointsStandard Deviation 0.1
p-value: <0.0595% CI: [-0.3, -0.1]Mixed Models Analysis
p-value: <0.0595% CI: [-0.7, -0.4]Mixed Models Analysis
Other Pre-specified

International Physical Activity Questionnaire (IPAQ)

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.

Time frame: baseline and 6 months

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

ArmMeasureGroupValue (MEAN)Dispersion
Cognitively Enhanced Tai Ji QuanInternational Physical Activity Questionnaire (IPAQ)baseline146 minutesStandard Error 12
Cognitively Enhanced Tai Ji QuanInternational Physical Activity Questionnaire (IPAQ)6 months273 minutesStandard Error 12.5
Standard Tai Ji QuanInternational Physical Activity Questionnaire (IPAQ)baseline145 minutesStandard Error 12
Standard Tai Ji QuanInternational Physical Activity Questionnaire (IPAQ)6 months267.9 minutesStandard Error 12
StretchingInternational Physical Activity Questionnaire (IPAQ)baseline145.8 minutesStandard Error 12.3
StretchingInternational Physical Activity Questionnaire (IPAQ)6 months147.6 minutesStandard Error 12.6
p-value: <0.0595% CI: [-2, 6]Mixed Models Analysis
p-value: <0.0595% CI: [84, 166]Mixed Models Analysis
Other Pre-specified

Quality of Life - EuroQol.

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.

Time frame: baseline, 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Cognitively Enhanced Tai Ji QuanQuality of Life - EuroQol.baseline.76 pointsStandard Deviation 0.01
Cognitively Enhanced Tai Ji QuanQuality of Life - EuroQol.6 months.90 pointsStandard Deviation 0.01
Standard Tai Ji QuanQuality of Life - EuroQol.baseline.77 pointsStandard Deviation 0.01
Standard Tai Ji QuanQuality of Life - EuroQol.6 months.90 pointsStandard Deviation 0.01
StretchingQuality of Life - EuroQol.baseline.77 pointsStandard Deviation 0.01
StretchingQuality of Life - EuroQol.6 months.76 pointsStandard Deviation 0.01
p-value: <0.0595% CI: [-0.04, 0.03]Mixed Models Analysis
p-value: <0.0595% CI: [0.03, 0.11]Mixed Models Analysis
Other Pre-specified

Sleep Quality - Pittsburgh Sleep Quality Index (PSQI)

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.

Time frame: baseline, 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Cognitively Enhanced Tai Ji QuanSleep Quality - Pittsburgh Sleep Quality Index (PSQI)baseline8.2 pointsStandard Deviation 0.3
Cognitively Enhanced Tai Ji QuanSleep Quality - Pittsburgh Sleep Quality Index (PSQI)6 months5.2 pointsStandard Deviation 0.3
Standard Tai Ji QuanSleep Quality - Pittsburgh Sleep Quality Index (PSQI)baseline8.3 pointsStandard Deviation 0.3
Standard Tai Ji QuanSleep Quality - Pittsburgh Sleep Quality Index (PSQI)6 months5.2 pointsStandard Deviation 0.3
StretchingSleep Quality - Pittsburgh Sleep Quality Index (PSQI)baseline8.1 pointsStandard Deviation 0.3
StretchingSleep Quality - Pittsburgh Sleep Quality Index (PSQI)6 months7.3 pointsStandard Deviation 0.3
p-value: <0.0595% CI: [-0.7, 0.8]Mixed Models Analysis
p-value: <0.0595% CI: [-3.1, -1.3]Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Jul 31, 2026