Trial Outcomes & Findings for Novel Interventions for GWVI (NCT NCT02661997)

NCT ID: NCT02661997

Last Updated: 2025-11-13

Results Overview

The Brief Pain Inventory (BPI) is a self-report measure that examines pain severity and interference with functioning in various life domains, including general activity, mood, walking activity, work, relationships, sleep, and enjoyment of life. In addition, the BPI asks questions about pain relief, pain quality, and patient perception of the cause of pain. It has been used and validated in a wide range of clinical conditions and is a gold standard measure for the assessment of pain and its impact. Test-retest reliability has been studied in a variety of pain populations and ranges from .83 to .98. Results of the Pain Interference subscale are reported below. Each item of the 7-item subscale is rated from 0 to 10 with higher scores reflecting a worse outcome. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 0 and a maximum score of 10.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

114 participants

Primary outcome timeframe

Change from baseline to post-treatment at 12 weeks

Results posted on

2025-11-13

Participant Flow

Participant milestones

Participant milestones
Measure
Tai Chi Intervention
All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
Wellness Intervention
The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
Baseline Assessment
STARTED
58
56
Baseline Assessment
COMPLETED
58
56
Baseline Assessment
NOT COMPLETED
0
0
Post-Treatment Assessment
STARTED
58
56
Post-Treatment Assessment
COMPLETED
48
50
Post-Treatment Assessment
NOT COMPLETED
10
6
3-month Follow-up Assessment
STARTED
58
56
3-month Follow-up Assessment
COMPLETED
52
50
3-month Follow-up Assessment
NOT COMPLETED
6
6
9-month Follow-up Assessment
STARTED
58
56
9-month Follow-up Assessment
COMPLETED
45
46
9-month Follow-up Assessment
NOT COMPLETED
13
10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Novel Interventions for GWVI

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Tai Chi Intervention
n=58 Participants
All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
Wellness Intervention
n=56 Participants
The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
Total
n=114 Participants
Total of all reporting groups
Race (NIH/OMB)
Asian
0 Participants
n=10 Participants
0 Participants
n=10 Participants
0 Participants
n=20 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=10 Participants
0 Participants
n=10 Participants
0 Participants
n=20 Participants
Race (NIH/OMB)
Black or African American
6 Participants
n=10 Participants
18 Participants
n=10 Participants
24 Participants
n=20 Participants
Age, Continuous
57.09 years
STANDARD_DEVIATION 8.40 • n=10 Participants
56.50 years
STANDARD_DEVIATION 7.41 • n=10 Participants
56.80 years
STANDARD_DEVIATION 7.90 • n=20 Participants
Sex: Female, Male
Female
10 Participants
n=10 Participants
10 Participants
n=10 Participants
20 Participants
n=20 Participants
Sex: Female, Male
Male
48 Participants
n=10 Participants
46 Participants
n=10 Participants
94 Participants
n=20 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=10 Participants
0 Participants
n=10 Participants
0 Participants
n=20 Participants
Race (NIH/OMB)
White
45 Participants
n=10 Participants
31 Participants
n=10 Participants
76 Participants
n=20 Participants
Race (NIH/OMB)
More than one race
6 Participants
n=10 Participants
3 Participants
n=10 Participants
9 Participants
n=20 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=10 Participants
4 Participants
n=10 Participants
5 Participants
n=20 Participants
Region of Enrollment
United States
58 Participants
n=10 Participants
56 Participants
n=10 Participants
114 Participants
n=20 Participants

PRIMARY outcome

Timeframe: Change from baseline to post-treatment at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 91 completed full data on this measure.

The Brief Pain Inventory (BPI) is a self-report measure that examines pain severity and interference with functioning in various life domains, including general activity, mood, walking activity, work, relationships, sleep, and enjoyment of life. In addition, the BPI asks questions about pain relief, pain quality, and patient perception of the cause of pain. It has been used and validated in a wide range of clinical conditions and is a gold standard measure for the assessment of pain and its impact. Test-retest reliability has been studied in a variety of pain populations and ranges from .83 to .98. Results of the Pain Interference subscale are reported below. Each item of the 7-item subscale is rated from 0 to 10 with higher scores reflecting a worse outcome. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 0 and a maximum score of 10.

Outcome measures

Outcome measures
Measure
Tai Chi Intervention
n=43 Participants
All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
Wellness Intervention
n=48 Participants
The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
Change in Brief Pain Inventory - Short Form (BPI) - Pain Interference
Baseline Measure
4.47 score on a scale
Standard Deviation 2.69
4.77 score on a scale
Standard Deviation 2.85
Change in Brief Pain Inventory - Short Form (BPI) - Pain Interference
Post-Treatment (12 weeks)
3.59 score on a scale
Standard Deviation 2.92
3.66 score on a scale
Standard Deviation 2.62

PRIMARY outcome

Timeframe: Change from baseline to post-treatment at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 91 completed full data on this measure.

The Brief Pain Inventory (BPI) is a self-report measure that examines pain severity and interference with functioning in various life domains, including general activity, mood, walking activity, work, relationships, sleep, and enjoyment of life. In addition, the BPI asks questions about pain relief, pain quality, and patient perception of the cause of pain. It has been used and validated in a wide range of clinical conditions and is a gold standard measure for the assessment of pain and its impact. Test-retest reliability has been studied in a variety of pain populations and ranges from .83 to .98. Results of the Pain Severity subscale are reported below. Each item of the 4-item subscale is rated from 0 to 10 with higher scores reflecting a worse outcome. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 0 and a maximum score of 10.

Outcome measures

Outcome measures
Measure
Tai Chi Intervention
n=43 Participants
All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
Wellness Intervention
n=48 Participants
The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
Change in Brief Pain Inventory - Short Form (BPI) - Pain Severity
Baseline Measure
4.28 score on a scale
Standard Deviation 1.94
4.75 score on a scale
Standard Deviation 2.38
Change in Brief Pain Inventory - Short Form (BPI) - Pain Severity
Post-Treatment (12 weeks)
4.02 score on a scale
Standard Deviation 2.51
4.43 score on a scale
Standard Deviation 2.46

SECONDARY outcome

Timeframe: Change from baseline to post-treatment at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 91 completed full data on this measure.

The Multidimensional Fatigue Inventory (MFI-20) is a widely-used self-report measure that quantifies symptoms of fatigue, including general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Internal consistency and test-retest reliability are strong for all subscales. Responses are made on a 5-point scale from 1-5, with higher scores reflecting greater fatigue. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 1 and a maximum score of 5. Results from the General Fatigue Subscale are provided below.

Outcome measures

Outcome measures
Measure
Tai Chi Intervention
n=43 Participants
All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
Wellness Intervention
n=48 Participants
The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
Change in Multi-dimensional Fatigue Inventory (MFI-20)
Baseline Measure
3.62 score on a scale
Standard Deviation 1.04
3.72 score on a scale
Standard Deviation 0.91
Change in Multi-dimensional Fatigue Inventory (MFI-20)
Post-Treatment (12 weeks)
3.55 score on a scale
Standard Deviation 1.06
3.42 score on a scale
Standard Deviation 0.93

SECONDARY outcome

Timeframe: Change from baseline to post-treatment at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 92 completed full data on this measure.

The PROMIS initiative developed new ways to measure patient-reported outcomes such as pain, fatigue, physical functioning, emotional distress, and social role participation that have a major impact on quality-of-life across a variety of chronic diseases. The PROMIS Global Health Scale asks participants to rate their health in terms of physical health, mental health, and satisfaction with social activities, and two scores are produced: Physical Health and Mental Health. Results from the Physical Health Subscale are presented below. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 1 and a maximum score of 5. Higher scores reflect a better outcome.

Outcome measures

Outcome measures
Measure
Tai Chi Intervention
n=44 Participants
All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
Wellness Intervention
n=48 Participants
The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
PROMIS Global Health Scale - Physical Health Subscale
Baseline Measure
2.88 score on a scale
Standard Deviation 0.70
2.93 score on a scale
Standard Deviation 0.74
PROMIS Global Health Scale - Physical Health Subscale
Post-Treatment (12 weeks)
3.00 score on a scale
Standard Deviation 0.80
3.02 score on a scale
Standard Deviation 0.74

SECONDARY outcome

Timeframe: Change from baseline to post-treatment (12 weeks)

Population: 98 Veterans participated in the post-treatment assessment, however only 42 completed full data on this measure. This measure could not be administered when the study changed to be a fully remote study during the pandemic.

The Walk 50FT is a widely used timed measure of fast walking speed. It involves a participant walking 50 feet without any use of an aid while study staff monitor and record their time in seconds using a stopwatch. Participants are instructed to walk "as fast as possible." Two trials of the Walk 50FT were conducted and an average score of these two trials was produced. A lower Walk 50FT score is indicative of higher (i.e., faster) walking speed. The Walk 50FT is empirically supported, possesses strong validity and reliability, and demonstrates sensitivity to change over time among individuals with chronic disorders and is a promising measure of physical functioning in patients with a pain-related condition.

Outcome measures

Outcome measures
Measure
Tai Chi Intervention
n=20 Participants
All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
Wellness Intervention
n=22 Participants
The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
50 Foot Walk Test
Baseline measure
10.72 seconds
Standard Deviation 2.26
10.55 seconds
Standard Deviation 3.96
50 Foot Walk Test
Post-treatment (12-weeks)
11.27 seconds
Standard Deviation 4.04
9.64 seconds
Standard Deviation 2.74

SECONDARY outcome

Timeframe: Change from baseline to post-treatment at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 42 completed full data on this measure. This measure could not be administered when the study changed to be a fully remote study during the pandemic.

The Trail Making Test (TMT) is one of the most popular neuropsychological tests and provides information on visual search, scanning, speed of processing, mental flexibility, and executive functioning. It consists of two parts: A and B. Part A requires an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper. Task B requires a similar task, however a participant is asked to draw a line alternating between numbers and letters (e.g., 1, A, 2, B, 3, C, etc). The score on each part represents the amount of time required to complete the task with higher scores reflecting a worse outcome. Results from Trails A are presented below.

Outcome measures

Outcome measures
Measure
Tai Chi Intervention
n=20 Participants
All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
Wellness Intervention
n=22 Participants
The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
Change in Trail Making Test (TMT) - Trails A
Baseline measure
25.28 seconds
Standard Deviation 8.67
27.96 seconds
Standard Deviation 9.34
Change in Trail Making Test (TMT) - Trails A
Post-treatment (12-weeks)
24.75 seconds
Standard Deviation 8.83
26.29 seconds
Standard Deviation 10.63

SECONDARY outcome

Timeframe: Change from baseline to post-treatment at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 40 completed full data on this measure. This measure could not be administered when the study changed to be a fully remote study during the pandemic.

The Trail Making Test (TMT) is one of the most popular neuropsychological tests and provides information on visual search, scanning, speed of processing, mental flexibility, and executive functioning. It consists of two parts: A and B. Trails A requires an individual to draw lines sequentially connecting 25 encircled numbers distributed on a sheet of paper. Trails B requires a similar task, however a participant is asked to draw a line alternating between numbers and letters (e.g., 1, A, 2, B, 3, C, etc). The score on each part represents the amount of time required to complete the task with higher scores reflecting a worse outcome. Results from Trails B is reported below.

Outcome measures

Outcome measures
Measure
Tai Chi Intervention
n=19 Participants
All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
Wellness Intervention
n=21 Participants
The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
Change in Trail Making Test (TMT) - Trails B
Baseline measure
65.91 seconds
Standard Deviation 30.25
63.52 seconds
Standard Deviation 24.21
Change in Trail Making Test (TMT) - Trails B
Post-treatment (12-weeks)
66.04 seconds
Standard Deviation 42.60
60.52 seconds
Standard Deviation 24.16

SECONDARY outcome

Timeframe: Change from baseline to post-treatment at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 42 completed full data on this measure. This measure could not be administered when the study changed to be a fully remote study during the pandemic.

The Hopkins Verbal Learning Test- Revised (HVLT-R) is a cognitive test of verbal learning and memory task where participants are instructed to learn a list of 12 nouns over three learning trials. Each time study staff read the list of words, participants are asked to recall as many words from the list as they can remember immediately afterwards. The sum of correctly recalled words over the three trials is a measure of total recall. Scores can range from 0 to 36 with higher scores reflect better a better outcome.

Outcome measures

Outcome measures
Measure
Tai Chi Intervention
n=20 Participants
All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
Wellness Intervention
n=22 Participants
The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
Change in Hopkins Verbal Learning Test - Revised (HVLT-R)
Baseline measure
22.25 total words recalled
Standard Deviation 4.32
21.27 total words recalled
Standard Deviation 4.10
Change in Hopkins Verbal Learning Test - Revised (HVLT-R)
Post-treatment (12-weeks)
23.85 total words recalled
Standard Deviation 3.91
22.59 total words recalled
Standard Deviation 4.71

SECONDARY outcome

Timeframe: Change from baseline to post-treatment at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 92 completed full data on this measure.

The PROMIS initiative developed new ways to measure patient-reported outcomes such as pain, fatigue, physical functioning, emotional distress, and social role participation that have a major impact on quality-of-life across a variety of chronic diseases. The PROMIS Global Health Scale asks participants to rate their health in terms of physical health, mental health, and satisfaction with social activities, and two scores are produced: Physical Health and Mental Health. Results from the Mental Health Subscale are presented below. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 1 and a maximum score of 5. Higher scores reflect a better outcome.

Outcome measures

Outcome measures
Measure
Tai Chi Intervention
n=44 Participants
All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
Wellness Intervention
n=48 Participants
The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
PROMIS Global Health Scale - Mental Health Subscale
Baseline Measure
2.44 units on a scale
Standard Deviation 0.93
2.67 units on a scale
Standard Deviation 0.84
PROMIS Global Health Scale - Mental Health Subscale
Post-treatment Measure (12-weeks)
2.73 units on a scale
Standard Deviation 1.11
2.83 units on a scale
Standard Deviation 0.82

SECONDARY outcome

Timeframe: Change from baseline to post-treatment at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 42 completed full data on this measure. This measure could not be administered when the study changed to be a fully remote study during the pandemic.

The Short Physical Performance Battery (SPPB) captures domains of strength, endurance, and balance and is highly predictive of disability. The SPPB is based on three timed measures of standing balance, walking (gait) speed, and ability to rise from a chair. The 4-Meter Walk Test is a measure of gate speed where participants are asked to walk 4-meters at a normal walking pace while being timed. Results from the 4-Meter Walk Test are presented below.

Outcome measures

Outcome measures
Measure
Tai Chi Intervention
n=20 Participants
All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
Wellness Intervention
n=22 Participants
The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
Short Physical Performance Battery (SPPB) - 4-Meter Walk Test
Baseline measure
5.26 seconds
Standard Deviation 1.14
5.54 seconds
Standard Deviation 0.92
Short Physical Performance Battery (SPPB) - 4-Meter Walk Test
Post-treatment (12-weeks)
5.23 seconds
Standard Deviation 1.19
4.70 seconds
Standard Deviation 1.02

SECONDARY outcome

Timeframe: Change from baseline to post-treatment at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 39 completed full data on this measure. This measure could not be administered when the study changed to be a fully remote study during the pandemic.

The Short Physical Performance Battery (SPPB) captures domains of strength, endurance, and balance and is highly predictive of disability. The SPPB consists of three timed measures: standing balance, walking speed, and ability to rise from a chair. The Chair Sit Test (CST) is a timed evaluation of the strength and power of lower-extremities. Participants are instructed to complete five chair stands from a sitting position with their arms folded across their chests. They are instructed to do this as fast as possible, while being timed. Lower scores reflect a better outcome.

Outcome measures

Outcome measures
Measure
Tai Chi Intervention
n=18 Participants
All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
Wellness Intervention
n=21 Participants
The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
Short Physical Performance Battery (SPPB) - Chair Stand Test (CST)
Baseline measure
13.60 seconds
Standard Deviation 3.13
12.49 seconds
Standard Deviation 3.39
Short Physical Performance Battery (SPPB) - Chair Stand Test (CST)
Post-treatment (12-weeks)
13.92 seconds
Standard Deviation 5.03
13.20 seconds
Standard Deviation 7.94

SECONDARY outcome

Timeframe: Change from baseline to post-treatment at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 41 completed full data on this measure. This measure could not be administered when the study changed to be a fully remote study during the pandemic.

The SPPB captures domains of strength, endurance, and balance and is highly predictive of disability. The SPPB consists of three timed measures: standing balance, walking speed, and ability to rise from a chair. The Standing Balance Test measures ability to balance while holding in three different positions for 10 seconds. For each position they are able to hold for 10 seconds, they receive a score of 1. If they are unable to hold the position, they receive a score of 0. To illustrate the minimal variability on this measure, results are provided below for the tandem position (the most difficult position to hold).

Outcome measures

Outcome measures
Measure
Tai Chi Intervention
n=19 Participants
All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
Wellness Intervention
n=22 Participants
The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
Short Physical Performance Battery (SPPB) - Standing Balance Test (SBT)
Post-treatment (12-weeks)
1.0 units on a scale
Standard Deviation 0
.95 units on a scale
Standard Deviation .21
Short Physical Performance Battery (SPPB) - Standing Balance Test (SBT)
Baseline measure
1.0 units on a scale
Standard Deviation 0
1.0 units on a scale
Standard Deviation 0

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline HSC at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 91 completed full data on this measure.

The Health Symptom Checklist consists of 34 frequently reported health and mental health symptoms from nine body systems (cardiac, pulmonary, dermatological, gastrointestinal, genitourinary, musculoskeletal, neurological, neuropsychological and psychological). On a 5 point scale from 0 (no) to 4 (very often), respondents indicate if they have experienced each symptom in the last 30 days, and if yes, how often. A response of 2 (about once per week) or greater is considered an endorsement of the symptom. All symptoms endorsed are added together for a total score. Total scores can range from 0 to 34 with higher scores indicating more symptoms.

Outcome measures

Outcome measures
Measure
Tai Chi Intervention
n=43 Participants
All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
Wellness Intervention
n=48 Participants
The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
Health Symptom Checklist (HSC)
Baseline Measure
18.82 score on a scale
Standard Deviation 7.87
17.53 score on a scale
Standard Deviation 8.35
Health Symptom Checklist (HSC)
Post-treatment
18.07 score on a scale
Standard Deviation 8.37
15.27 score on a scale
Standard Deviation 8.38

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline PCL-5 at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 91 completed full data on this measure.

The PTSD Checklist for DSM-5 (PCL-5) is a self-report measure consisting of 20 items that parallel the DSM-5 posttraumatic stress disorder criteria. Respondents indicate on a 5-point scale (0-4) how much they have been bothered in the last month by particular symptoms that are related to stressful military experiences. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 0 and a maximum score of 4.The DSM-IV version of the PCL has been shown to have excellent reliability and validity.

Outcome measures

Outcome measures
Measure
Tai Chi Intervention
n=43 Participants
All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
Wellness Intervention
n=48 Participants
The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
The PTSD Checklist for DSM-5 (PCL-5)
Post-treatment
1.72 units on a scale
Standard Deviation 1.01
1.60 units on a scale
Standard Deviation 0.96
The PTSD Checklist for DSM-5 (PCL-5)
Baseline Measure
1.85 units on a scale
Standard Deviation 1.04
1.86 units on a scale
Standard Deviation 1.02

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline ISI at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 86 completed full data on this measure.

The Insomnia Severity Index (ISI) is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia. It is comprised of seven questions that are responded to on a scale from 0 to 4.. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 0 and a maximum score of 4, with higher scores reflecting greater insomnia symptom severity.

Outcome measures

Outcome measures
Measure
Tai Chi Intervention
n=43 Participants
All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
Wellness Intervention
n=43 Participants
The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
Insomnia Severity Index (ISI)
2.40 units on a scale
Standard Deviation 1.11
2.38 units on a scale
Standard Deviation 0.90

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Population: This data was collected on all 114 participants who were validly randomized for this study.

Study staff will monitor number of intervention sessions attended. The maximum total number of sessions is 24 (range 0-24) with higher numbers showing greater number of sessions attended.

Outcome measures

Outcome measures
Measure
Tai Chi Intervention
n=58 Participants
All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
Wellness Intervention
n=56 Participants
The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
Participant Compliance Log - Intervention Sessions Attended
15.62 sessions attended
Standard Deviation 7.33
16.95 sessions attended
Standard Deviation 7.62

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Population: This data was collected on all 114 participants who were validly randomized for this study.

Percentage of participants who completed the post-treatment assessment.

Outcome measures

Outcome measures
Measure
Tai Chi Intervention
n=58 Participants
All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
Wellness Intervention
n=56 Participants
The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
Participant Compliance Log - Assessment Sessions Attended
82.8 percentage of participants
89.3 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Population: 58 Veterans were randomized to Tai Chi, however only 54 completed full data on this measure.

This measure will monitor compliance with home Tai Chi practice during the intervention. Average Tai Chi practice minutes per week is reported.

Outcome measures

Outcome measures
Measure
Tai Chi Intervention
n=54 Participants
All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
Wellness Intervention
The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
Weekly Practice Log Sheet
183.62 minutes per week
Standard Deviation 87.70

OTHER_PRE_SPECIFIED outcome

Timeframe: Difference between two intervention groups at post-treatment (12 weeks)

Population: 98 Veterans participated in the post-treatment assessment, however only 87 completed full data on this measure.

The Client Satisfaction Questionnaire (CSQ) is is an 8-item measure that assesses satisfaction with both the interventions. Each item is responded to on a 4-point scale (1-4) and items are summed for a total score that can range from 8-32 with higher scores reflecting greater satisfaction.

Outcome measures

Outcome measures
Measure
Tai Chi Intervention
n=42 Participants
All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
Wellness Intervention
n=45 Participants
The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
Client Satisfaction Questionnaire
28.81 units on a scale
Standard Deviation 3.64
27.67 units on a scale
Standard Deviation 3.74

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline DASS at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 92 completed full data on this measure.

The Depression Anxiety Sensitivity Scale (DASS) is a 21 item questionnaire that is responded to on a 4-point scale that ranges from 0-3. There are three self-report scales designed to measure the negative emotional states of depression, anxiety and stress. Scores are obtained by summing the items that comprise each of the three scales, with higher scores reflecting greater symptomatology. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 0 and a maximum score of 3.The DASS was constructed not merely as another set of scales to measure conventionally defined emotional states, but to further the process of defining, understanding, and measuring the ubiquitous and clinically significant emotional states usually described as depression, anxiety and stress.

Outcome measures

Outcome measures
Measure
Tai Chi Intervention
n=44 Participants
All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
Wellness Intervention
n=48 Participants
The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
Depression Anxiety Sensitivity Scale (DASS) - Depression Scale
Baseline Measure
1.18 units on a scale
Standard Deviation 0.90
1.03 units on a scale
Standard Deviation 0.87
Depression Anxiety Sensitivity Scale (DASS) - Depression Scale
Post-treatment
0.95 units on a scale
Standard Deviation 0.97
0.82 units on a scale
Standard Deviation 0.74

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline DASS at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 92 completed full data on this measure.

The Depression Anxiety Sensitivity Scale (DASS) is a 21 item questionnaire that is responded to on a 4-point scale that ranges from 0-3. There are three self-report scales designed to measure the negative emotional states of depression, anxiety and stress. Scores are obtained by summing the items that comprise each of the three scales, with higher scores reflecting greater symptomatology. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 0 and a maximum score of 3.The DASS was constructed not merely as another set of scales to measure conventionally defined emotional states, but to further the process of defining, understanding, and measuring the ubiquitous and clinically significant emotional states usually described as depression, anxiety and stress.

Outcome measures

Outcome measures
Measure
Tai Chi Intervention
n=44 Participants
All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
Wellness Intervention
n=48 Participants
The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
Depression Anxiety Sensitivity Scale (DASS) - Anxiety Scale
Baseline Measure
0.95 units on a scale
Standard Deviation 0.73
0.86 units on a scale
Standard Deviation 0.66
Depression Anxiety Sensitivity Scale (DASS) - Anxiety Scale
Post-treatment
0.85 units on a scale
Standard Deviation 0.75
0.69 units on a scale
Standard Deviation 0.62

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline DASS at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 92 completed full data on this measure.

The Depression Anxiety Sensitivity Scale (DASS) is a 21 item questionnaire that is responded to on a 4-point scale that ranges from 0-3. There are three self-report scales designed to measure the negative emotional states of depression, anxiety and stress. Scores are obtained by summing the items that comprise each of the three scales, with higher scores reflecting greater symptomatology. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 0 and a maximum score of 3.The DASS was constructed not merely as another set of scales to measure conventionally defined emotional states, but to further the process of defining, understanding, and measuring the ubiquitous and clinically significant emotional states usually described as depression, anxiety and stress.

Outcome measures

Outcome measures
Measure
Tai Chi Intervention
n=44 Participants
All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
Wellness Intervention
n=48 Participants
The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
Depression Anxiety Sensitivity Scale (DASS) - Stress Scale
Baseline Measure
1.21 units on a scale
Standard Deviation 0.73
1.36 units on a scale
Standard Deviation 0.69
Depression Anxiety Sensitivity Scale (DASS) - Stress Scale
Post-treatment
1.14 units on a scale
Standard Deviation 0.81
1.12 units on a scale
Standard Deviation 0.70

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline PCS at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 89 completed full data on this measure.

The PCS is a 13-item self-report scale that assesses the degree to which people engage in three subtypes of pain catastrophizing: rumination, magnification, and helplessness. Each item is responded to on a 5 point scale (0-4). Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 0 and a maximum score of 4, with higher scores reflecting greater pain catastrophizing. It is one of the most widely used instruments for measuring catastrophic thinking in relation to pain.

Outcome measures

Outcome measures
Measure
Tai Chi Intervention
n=44 Participants
All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
Wellness Intervention
n=45 Participants
The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
Change in the Pain Catastrophizing Scale (PCS)
Baseline Measure
1.61 units on a scale
Standard Deviation 1.10
1.49 units on a scale
Standard Deviation 1.16
Change in the Pain Catastrophizing Scale (PCS)
Post-treatment
1.43 units on a scale
Standard Deviation 0.99
1.31 units on a scale
Standard Deviation 1.05

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline WHYMPI at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 91 completed full data on this measure.

The West Haven-Yale Multidimensional Pain Inventory (WHMPI) is a well-validated measure of the experience of chronic pain and has been shown to be applicable across a variety of clinical pain conditions. The 52-item inventory is divided into three parts: 1) Important dimensions of the chronic pain experience, 2) patient perceptions of how important others respond to their pain, and 3) engagement in everyday activities. Patient's responses to WHYMPI items are made on a 7-point scale (0-6). The focus of the analysis reported before is on the 18 items that constitute Part 3. This General Activity Scale was scored by summing responses and then obtaining an average by dividing by the number of non-missing items. Total average scores range from 0-6 with higher scores reflecting greater engagement in common everyday activities.

Outcome measures

Outcome measures
Measure
Tai Chi Intervention
n=43 Participants
All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
Wellness Intervention
n=48 Participants
The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
Change in West Haven-Yale Multidimensional Pain Inventory (WHYMPI) - General Activity Scale
Baseline Measure
2.84 units on a scale
Standard Deviation 1.06
2.58 units on a scale
Standard Deviation 0.94
Change in West Haven-Yale Multidimensional Pain Inventory (WHYMPI) - General Activity Scale
Post-treatment
2.76 units on a scale
Standard Deviation 1.00
2.80 units on a scale
Standard Deviation 1.07

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline CPSS at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 91 completed full data on this measure.

The Chronic Pain Self-Efficacy Scale (CPSS) is a 22-item questionnaire designed to measure chronic pain patients' perceived self-efficacy to cope with the consequences of chronic pain. Questions are broken down into three categories: self-efficacy for pain management, self-efficacy for physical function, and self-efficacy for coping with symptoms. Each item in the CPSS is presented as a question (e.g., "How certain are you that you can decrease your pain quite a bit?"). Participants rate each belief on a 10-point Likert scale (range 10-100). A total score is calculated by first summing the item responses across all three categories. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 10 and a maximum score of 100, with higher scores reflecting greater perceived self-efficacy.

Outcome measures

Outcome measures
Measure
Tai Chi Intervention
n=43 Participants
All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
Wellness Intervention
n=48 Participants
The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
Change in Chronic Pain Self-Efficacy Scale (CPSS)
Baseline Measure
61.09 units on a scale
Standard Deviation 18.60
57.25 units on a scale
Standard Deviation 18.45
Change in Chronic Pain Self-Efficacy Scale (CPSS)
Post-treatment
63.02 units on a scale
Standard Deviation 18.81
61.52 units on a scale
Standard Deviation 19.94

OTHER_PRE_SPECIFIED outcome

Timeframe: Post-treatment measure taken at 12 weeks

Population: 72 Veterans participated in this week 12 assessment.

The Group Cohesiveness Scale is a self-report measure that examines group cohesion within a therapeutic environment. Each of the 7 questions are responded to on a 5-point scale (1-5). Scores are obtained by summing the items with higher scores reflecting greater group cohesiveness.

Outcome measures

Outcome measures
Measure
Tai Chi Intervention
n=33 Participants
All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
Wellness Intervention
n=39 Participants
The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
Group Cohesiveness Scale (GSC)
28.12 units on a scale
Standard Deviation 6.47
30.49 units on a scale
Standard Deviation 4.67

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline PROMIS Self-Efficacy at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 92 completed full data on this measure.

The Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Symptoms is an 8-item self-report measure that examines elements of self-care. Each item is responded to on a 5 point scale ranging from 1-5. Raw scores are calculated by summing responses to all the items (score range 8-40), and then converted to a T-score using a conversion table located in the administration guide provided for the PROMIS instruments. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. Higher scores reflect greater confidence in one's ability to manage one's symptoms

Outcome measures

Outcome measures
Measure
Tai Chi Intervention
n=44 Participants
All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
Wellness Intervention
n=48 Participants
The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
PROMIS Self-Efficacy for Managing Symptoms
Post-treatment
46.51 units on a scale
Standard Deviation 9.76
46.00 units on a scale
Standard Deviation 7.70
PROMIS Self-Efficacy for Managing Symptoms
Baseline Measure
45.75 units on a scale
Standard Deviation 9.66
45.71 units on a scale
Standard Deviation 8.08

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline MAAS at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 91 completed full data on this measure.

The Mindfulness Attention Awareness Scale (MAAS) is a 15-item self-report measure that assesses participants' openness towards, awareness of, and attention to the present. This scale can reveal information about one's self-regulation and well-being. Each item is responded to on a 6-point scale from 1 (almost always) to 6 (almost never) with higher scores reflecting greater mindfulness awareness. Sum scores are changed to mean scores so they are in the same metric as the individual items constituting the scale with a minimum score of 1 and a maximum score of 6.

Outcome measures

Outcome measures
Measure
Tai Chi Intervention
n=43 Participants
All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
Wellness Intervention
n=48 Participants
The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
Mindfulness Attention Awareness Scale (MAAS)
Baseline Measure
3.85 units on a scale
Standard Deviation 1.16
3.91 units on a scale
Standard Deviation 1.05
Mindfulness Attention Awareness Scale (MAAS)
Post-treatment
3.99 units on a scale
Standard Deviation 1.24
4.18 units on a scale
Standard Deviation 1.12

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline measurements at 12 weeks

Population: 42 Veterans participated in the in-person post-treatment assessment and all 42 completed full data on this measure.

Study staff recorded participants' height in inches and weight in pounds. Weight and height measurements were used to calculate Body Mass Index using the formula: \[weight (lb) / height (in)\^2\] x 703. This data is only available for the participants who participated in-person.

Outcome measures

Outcome measures
Measure
Tai Chi Intervention
n=20 Participants
All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
Wellness Intervention
n=22 Participants
The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
Body Mass Index (BMI)
Baseline Measure
31.23 kg/m^2
Standard Deviation 6.03
31.43 kg/m^2
Standard Deviation 4.90
Body Mass Index (BMI)
Post-treatment
31.43 kg/m^2
Standard Deviation 5.95
31.87 kg/m^2
Standard Deviation 4.18

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline measurements at 12 weeks

Population: 42 Veterans participated in the in-person post-treatment assessment and data for all 42 is available on this measure.

Systolic pressures were measured in mmHg using a blood pressure cuff and sphygmomanometer. Two blood pressure readings were taken at each assessment point, and the average was used. This data is only available for the participants who were in-person.

Outcome measures

Outcome measures
Measure
Tai Chi Intervention
n=20 Participants
All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
Wellness Intervention
n=22 Participants
The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
Systolic Blood Pressure
Baseline Measure
127.07 millimeters of mercury
Standard Deviation 16.05
126.64 millimeters of mercury
Standard Deviation 11.41
Systolic Blood Pressure
Post-treatment
125.49 millimeters of mercury
Standard Deviation 15.18
128.92 millimeters of mercury
Standard Deviation 13.57

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline measurements at 12-weeks

Population: 42 Veterans participated in this in-person post-treatment assessment and data is available for all 42.

Diastolic pressures were measured in mmHg using a blood pressure cuff and sphygmomanometer. Two blood pressure readings were taken at each assessment point, and the average was used. This data is only available for the participants who were in-person.

Outcome measures

Outcome measures
Measure
Tai Chi Intervention
n=22 Participants
All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
Wellness Intervention
n=20 Participants
The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
Diastolic Blood Pressure
Baseline Measure
84.70 millimeters of mercury
Standard Deviation 10.79
86.33 millimeters of mercury
Standard Deviation 9.66
Diastolic Blood Pressure
Post-treatment
82.66 millimeters of mercury
Standard Deviation 7.75
85.23 millimeters of mercury
Standard Deviation 11.81

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline PAR at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 95 completed full data on this measure.

The Physical Activity Recall (PAR) is a measure that was administered by study staff in an interview format. The PAR asks participants' to report time they spent engaged in general physical activity, strength building activities, and activities that involve flexibility over the past week. For the measure of general physical activity, all activity that is of at least moderate intensity is counted and is reported as hours of activity in the past week.

Outcome measures

Outcome measures
Measure
Tai Chi Intervention
n=47 Participants
All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
Wellness Intervention
n=48 Participants
The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
Physical Activity Recall (PAR) - General Physical Activity
Baseline Measure
9.05 hours per week
Standard Deviation 10.34
10.55 hours per week
Standard Deviation 9.82
Physical Activity Recall (PAR) - General Physical Activity
Post-treatment
9.66 hours per week
Standard Deviation 10.95
9.11 hours per week
Standard Deviation 9.14

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline PAR Strength time at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 95 completed full data on this measure.

The Physical Activity Recall (PAR) is a measure that was administered by study staff in an interview format. The PAR asks participants' to report time they spent engaged in general physical activity, strength building activities, and activities that involve flexibility over the past week. For the measure of strength activity, time spent engaged in strength building activity over the past seven days is totaled and is reported as hours of strength activity in the past week.

Outcome measures

Outcome measures
Measure
Tai Chi Intervention
n=47 Participants
All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
Wellness Intervention
n=48 Participants
The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
Physical Activity Recall (PAR) - Strength Activity
Baseline Measure
0.40 hours of activity per week
Standard Deviation 0.89
1.04 hours of activity per week
Standard Deviation 3.95
Physical Activity Recall (PAR) - Strength Activity
Post-treatment
0.55 hours of activity per week
Standard Deviation 1.13
0.32 hours of activity per week
Standard Deviation 0.89

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline PAR Flexibility time at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 95 completed full data on this measure.

The Physical Activity Recall (PAR) is a measure that was administered by study staff in an interview format. The PAR asks participants' to report time they spent engaged in general physical activity, strength building activities, and activities that involve flexibility over the past week. For the measure of flexibility activity, time spent engaged in activity that involve flexibility over the past seven days is totaled and is reported as hours of flexibility activity in the past week.

Outcome measures

Outcome measures
Measure
Tai Chi Intervention
n=47 Participants
All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
Wellness Intervention
n=48 Participants
The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
Physical Activity Recall (PAR) - Flexibility Activity
Baseline Measure
0.52 Hours of activity per week
Standard Deviation 0.81
0.57 Hours of activity per week
Standard Deviation 0.94
Physical Activity Recall (PAR) - Flexibility Activity
Post-treatment
1.75 Hours of activity per week
Standard Deviation 1.86
0.46 Hours of activity per week
Standard Deviation 0.77

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline EPII at 12 weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 50 completed full data on this measure.

The Epidemic - Pandemic Impacts Inventory (EPII) is a 92-item questionnaire. This recently-developed measure was designed to learn about and describe the impact of the coronavirus disease pandemic on various domains of personal and family life, including employment, education, home life, social life, economic, physical health, infection experiences, and positive changes. This instrument was only administered to the remote participants, after the pandemic started. Participants were asked to respond to each item with one of the following four responses: 1) "Yes, me", 2) "Yes, person in home", 3) "no", and 4) "not applicable". Any "yes" response was coded as 1 and a "no" or "not applicable" response was coded as 0. Two scales were created (Positive Impacts and Negative Impacts) by summing the items for each scale. Negative Impacts are reported here (possible response range of 0-73), with higher scores indicating greater negative impact of the pandemic.

Outcome measures

Outcome measures
Measure
Tai Chi Intervention
n=24 Participants
All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
Wellness Intervention
n=26 Participants
The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
The Epidemic - Pandemic Impacts Inventory (EPII) - Negative Impacts
Baseline Measure
17.25 units on a scale
Standard Deviation 10.66
18.58 units on a scale
Standard Deviation 8.83
The Epidemic - Pandemic Impacts Inventory (EPII) - Negative Impacts
Post-treatment
16.95 units on a scale
Standard Deviation 10.61
17.29 units on a scale
Standard Deviation 8.21

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline EPII at 12 weeks Change from baseline EPII at 12-weeks

Population: 98 Veterans participated in the post-treatment assessment, however only 50 completed full data on this measure.

The Epidemic - Pandemic Impacts Inventory (EPII) is a 92-item questionnaire. This recently-developed measure was designed to learn about and describe the impact of the coronavirus disease pandemic on various domains of personal and family life, including employment, education, home life, social life, economic, physical health, infection experiences, and positive changes. This instrument was only administered to the remote participants, after the pandemic started. Participants were asked to respond to each item with one of the following four responses: 1) "Yes, me", 2) "Yes, person in home", 3) "no", and 4) "not applicable". Any "yes" response was coded as 1 and a "no" or "not applicable" response was coded as 0. Two scales were created (Positive Impacts and Negative Impacts) by summing the items for each scale. Positive Impacts are reported here (possible response range of 0-18), with higher scores indicating greater positive impact of the pandemic.

Outcome measures

Outcome measures
Measure
Tai Chi Intervention
n=24 Participants
All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
Wellness Intervention
n=26 Participants
The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
The Epidemic - Pandemic Impacts Inventory (EPII) - Positive Impacts
Baseline Measure
5.05 units on a scale
Standard Deviation 3.53
7.38 units on a scale
Standard Deviation 4.60
The Epidemic - Pandemic Impacts Inventory (EPII) - Positive Impacts
Post-treatment
6.04 units on a scale
Standard Deviation 5.01
8.83 units on a scale
Standard Deviation 4.87

Adverse Events

Tai Chi Intervention

Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths

Wellness Intervention

Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Tai Chi Intervention
n=58 participants at risk
Tai Chi Intervention: All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
Wellness Intervention
n=56 participants at risk
Wellness Intervention: The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
Psychiatric disorders
Detox from opiates
0.00%
0/58 • 1 year
1.8%
1/56 • Number of events 1 • 1 year
Cardiac disorders
Hospitalization for cardiac symptoms
0.00%
0/58 • 1 year
1.8%
1/56 • Number of events 1 • 1 year

Other adverse events

Other adverse events
Measure
Tai Chi Intervention
n=58 participants at risk
Tai Chi Intervention: All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
Wellness Intervention
n=56 participants at risk
Wellness Intervention: The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
Endocrine disorders
Blood sugar elevated
0.00%
0/58 • 1 year
1.8%
1/56 • Number of events 1 • 1 year
Vascular disorders
Blood pressure elevated
0.00%
0/58 • 1 year
1.8%
1/56 • Number of events 1 • 1 year
Skin and subcutaneous tissue disorders
Cyst on back
1.7%
1/58 • Number of events 1 • 1 year
0.00%
0/56 • 1 year
General disorders
Dizziness
1.7%
1/58 • Number of events 1 • 1 year
0.00%
0/56 • 1 year
General disorders
Feeling unwell and exhausted
1.7%
1/58 • Number of events 1 • 1 year
0.00%
0/56 • 1 year

Additional Information

Barbara L. Niles, Ph.D.

VA Boston Healthcare System

Phone: 857-364-4128

Results disclosure agreements

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