Trial Outcomes & Findings for Yoga and Physical Activity for Veterans (NCT NCT03509909)
NCT ID: NCT03509909
Last Updated: 2024-11-21
Results Overview
Semi-structured clinical interview assessing severity of PTSD symptoms administered by a trained, blinded assessor. The range of scores is 0-80. Mpre-Mpost is presented, so positive numbers indicate a reduction in PTSD symptom severity from before to after the intervention.
COMPLETED
NA
117 participants
Baseline to post-treatment (approx 12 weeks)
2024-11-21
Participant Flow
Participant milestones
| Measure |
Hatha Yoga
12- week group-based yoga class
Hatha yoga: Manualized hatha yoga
|
Supportive Exercise
12-week group-based stretching and strengthening class
Supportive physical activity: Manualized stretching and strengthening
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
50
|
|
Overall Study
COMPLETED
|
46
|
37
|
|
Overall Study
NOT COMPLETED
|
21
|
13
|
Reasons for withdrawal
| Measure |
Hatha Yoga
12- week group-based yoga class
Hatha yoga: Manualized hatha yoga
|
Supportive Exercise
12-week group-based stretching and strengthening class
Supportive physical activity: Manualized stretching and strengthening
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
16
|
9
|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
|
Overall Study
Adverse Event
|
2
|
0
|
Baseline Characteristics
Yoga and Physical Activity for Veterans
Baseline characteristics by cohort
| Measure |
Hatha Yoga
n=67 Participants
12- week group-based yoga class
Hatha yoga: Manualized hatha yoga
|
Supportive Exercise
n=50 Participants
12-week group-based stretching and strengthening class
Supportive physical activity: Manualized stretching and strengthening
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.9 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
48.4 years
STANDARD_DEVIATION 13.0 • n=7 Participants
|
47 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
12 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Martial status
Divorced, separated or widowed
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Martial status
Married, common law or permanent partner
|
37 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Martial status
Never married
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Education
High school or GED
|
16 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Education
Some college
|
21 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Education
College degree
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Education
Post-college
|
18 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Employment
Full time
|
28 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Employment
Not in paid workforce
|
22 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Employment
Part time
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Employment
Unemployed
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to post-treatment (approx 12 weeks)Population: Differs from the total population due to missing data. Includes individuals with both time points because of the nature of the change score.
Semi-structured clinical interview assessing severity of PTSD symptoms administered by a trained, blinded assessor. The range of scores is 0-80. Mpre-Mpost is presented, so positive numbers indicate a reduction in PTSD symptom severity from before to after the intervention.
Outcome measures
| Measure |
Hatha Yoga
n=48 Participants
12- week group-based yoga class
Hatha yoga: Manualized hatha yoga
|
Supportive Exercise
n=39 Participants
12-week group-based stretching and strengthening class
Supportive physical activity: Manualized stretching and strengthening
|
|---|---|---|
|
Clinician Administered PTSD Scale for Diagnostic and Statistical Manual Version 5 (CAPS-5)
|
3.92 change in units on a scale
Standard Deviation 10.05
|
3.46 change in units on a scale
Standard Deviation 10.55
|
SECONDARY outcome
Timeframe: Baseline to post-treatment (approx 12 weeks)Population: Differs from the total population due to missing data. Includes individuals with both time points because of the nature of the change score.
Self-report measure of depressive symptoms with a range of 0-27. Mpre-Mpost is presented, so positive numbers indicate a reduction in depression severity.
Outcome measures
| Measure |
Hatha Yoga
n=43 Participants
12- week group-based yoga class
Hatha yoga: Manualized hatha yoga
|
Supportive Exercise
n=36 Participants
12-week group-based stretching and strengthening class
Supportive physical activity: Manualized stretching and strengthening
|
|---|---|---|
|
Patient Health Questionnaire Depression Items (PHQ-9)
|
3.79 change in units on a scale
Standard Deviation 6.01
|
2.11 change in units on a scale
Standard Deviation 4.47
|
SECONDARY outcome
Timeframe: Baseline to post-treatment (approx 12 weeks)Population: Differs from the total population due to missing data. Includes individuals with both time points because of the nature of the change score.
Self-report measure of anxiety symptoms with "state" and "trait" subscales; state is reported. The subscale scores range from 20 to 80. Mpre-Mpost is presented, so positive numbers indicate a reduction in anxiety.
Outcome measures
| Measure |
Hatha Yoga
n=44 Participants
12- week group-based yoga class
Hatha yoga: Manualized hatha yoga
|
Supportive Exercise
n=32 Participants
12-week group-based stretching and strengthening class
Supportive physical activity: Manualized stretching and strengthening
|
|---|---|---|
|
State-Trait Anxiety Inventory, State Subscale
|
0.23 change in units on a scale
Standard Deviation 5.61
|
-0.53 change in units on a scale
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: Baseline to post-treatment (approx 12 weeks)Population: Differs from the total population due to missing data. Includes individuals with both time points because of the nature of the change score.
Self-report measure of anger with three major subscales (state anger, trait anger and anger control index), which are quantified as T-scores (i.e., 50 indicates the population mean with a standard deviation of 10), calculated from published adult norms tables. Change in T-scores, Tpre-Tpost, is presented, so positive numbers indicate a reduction in anger.
Outcome measures
| Measure |
Hatha Yoga
n=46 Participants
12- week group-based yoga class
Hatha yoga: Manualized hatha yoga
|
Supportive Exercise
n=36 Participants
12-week group-based stretching and strengthening class
Supportive physical activity: Manualized stretching and strengthening
|
|---|---|---|
|
State-Trait Anger Expression Inventory - II (STAXI-II), State Anger Subscale
|
1.02 change in T-score
Standard Deviation 9.65
|
1.08 change in T-score
Standard Deviation 6.94
|
SECONDARY outcome
Timeframe: Baseline to post-treatment (approx 12 weeks)Population: Differs from the total population due to missing data. Includes individuals with both time points because of the nature of the change score.
Self-report measure of insomnia with a range of 0-28. Mpre-Mpost is presented, so positive numbers indicate a reduction in sleep disturbance.
Outcome measures
| Measure |
Hatha Yoga
n=45 Participants
12- week group-based yoga class
Hatha yoga: Manualized hatha yoga
|
Supportive Exercise
n=33 Participants
12-week group-based stretching and strengthening class
Supportive physical activity: Manualized stretching and strengthening
|
|---|---|---|
|
Insomnia Severity Index
|
2.73 change in units on a scale
Standard Deviation 4.24
|
1.64 change in units on a scale
Standard Deviation 4.94
|
SECONDARY outcome
Timeframe: Baseline to post-treatment (approx 12 weeks)Population: Differs from the total population due to missing data. Includes individuals with both time points because of the nature of the change score. Loss of data increased as scale is invalid if all items are not answered.
Self-report measure of pain interference, reported as a T-score (i.e., 50 indicates the population mean with a standard deviation of 10) calculated from published adult norms table. Change in T-scores, Tpre-Tpost, is presented, so positive numbers indicate a reduction in pain interference.
Outcome measures
| Measure |
Hatha Yoga
n=30 Participants
12- week group-based yoga class
Hatha yoga: Manualized hatha yoga
|
Supportive Exercise
n=25 Participants
12-week group-based stretching and strengthening class
Supportive physical activity: Manualized stretching and strengthening
|
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference 4a
|
0.8 change in T-score
Standard Deviation 8.47
|
0.92 change in T-score
Standard Deviation 6.05
|
Adverse Events
Hatha Yoga
Supportive Exercise
Serious adverse events
| Measure |
Hatha Yoga
n=67 participants at risk
12- week group-based yoga class
Hatha yoga: Manualized hatha yoga
|
Supportive Exercise
n=50 participants at risk
12-week group-based stretching and strengthening class
Supportive physical activity: Manualized stretching and strengthening
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Broken bones
|
0.00%
0/67 • 24 weeks
|
2.0%
1/50 • Number of events 1 • 24 weeks
|
|
Psychiatric disorders
Alcohol withdrawal
|
1.5%
1/67 • Number of events 1 • 24 weeks
|
0.00%
0/50 • 24 weeks
|
|
Psychiatric disorders
Overdose
|
1.5%
1/67 • Number of events 1 • 24 weeks
|
0.00%
0/50 • 24 weeks
|
Other adverse events
| Measure |
Hatha Yoga
n=67 participants at risk
12- week group-based yoga class
Hatha yoga: Manualized hatha yoga
|
Supportive Exercise
n=50 participants at risk
12-week group-based stretching and strengthening class
Supportive physical activity: Manualized stretching and strengthening
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal issues
|
3.0%
2/67 • Number of events 2 • 24 weeks
|
10.0%
5/50 • Number of events 5 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle/tissue soreness
|
6.0%
4/67 • Number of events 4 • 24 weeks
|
10.0%
5/50 • Number of events 5 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.0%
6/67 • Number of events 6 • 24 weeks
|
18.0%
9/50 • Number of events 9 • 24 weeks
|
|
Psychiatric disorders
Emotional distress
|
9.0%
6/67 • Number of events 6 • 24 weeks
|
4.0%
2/50 • Number of events 2 • 24 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/67 • 24 weeks
|
8.0%
4/50 • Number of events 4 • 24 weeks
|
|
Infections and infestations
Symptoms of illness, including cold, flu and COVID-19
|
16.4%
11/67 • Number of events 11 • 24 weeks
|
16.0%
8/50 • Number of events 8 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
9.0%
6/67 • Number of events 6 • 24 weeks
|
16.0%
8/50 • Number of events 8 • 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place