Trial Outcomes & Findings for Exercise Training to Improve PTSD Symptoms and Health in Older Veterans (NCT NCT04199182)
NCT ID: NCT04199182
Last Updated: 2026-03-25
Results Overview
PTSD symptoms over the previous month will be assessed with the CAPS-5 clinical interview. Total symptom severity score and symptom cluster severity scores will be calculated. Scores range from 0 to 80, with higher scores reflecting more severe PTSD symptoms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
6 months
Results posted on
2026-03-25
Participant Flow
The participants are explained the nature, purpose, and procedure of the study and asked to sign an informed consent that will explain the potential risks and benefits of the study participation.
Participant milestones
| Measure |
Exercise
Progressive, multi-component supervised exercise training group.
|
Healthy Aging Attention Control
A health education program that addresses topics relevant to older adults.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
39
|
|
Overall Study
COMPLETED
|
25
|
29
|
|
Overall Study
NOT COMPLETED
|
16
|
10
|
Reasons for withdrawal
| Measure |
Exercise
Progressive, multi-component supervised exercise training group.
|
Healthy Aging Attention Control
A health education program that addresses topics relevant to older adults.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
9
|
7
|
|
Overall Study
Lost to Follow-up
|
7
|
3
|
Baseline Characteristics
Exercise Training to Improve PTSD Symptoms and Health in Older Veterans
Baseline characteristics by cohort
| Measure |
Exercise
n=41 Participants
Progressive, multi-component supervised exercise training group.
|
Healthy Aging Attention Control
n=39 Participants
A health education program that addresses topics relevant to older adults.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.3 Years
STANDARD_DEVIATION 4.3 • n=138 Participants
|
72.3 Years
STANDARD_DEVIATION 3.6 • n=62 Participants
|
71.8 Years
STANDARD_DEVIATION 3.9 • n=123 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=138 Participants
|
6 Participants
n=62 Participants
|
13 Participants
n=123 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=138 Participants
|
33 Participants
n=62 Participants
|
67 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=138 Participants
|
0 Participants
n=62 Participants
|
1 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=138 Participants
|
38 Participants
n=62 Participants
|
77 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=138 Participants
|
1 Participants
n=62 Participants
|
2 Participants
n=123 Participants
|
|
Clinician-Administered PTSD Scale for DSM-V (CAPS-5)
|
29.6 units on a scale
STANDARD_DEVIATION 9.4 • n=138 Participants
|
27.4 units on a scale
STANDARD_DEVIATION 9.32 • n=62 Participants
|
28.8 units on a scale
STANDARD_DEVIATION 9.4 • n=123 Participants
|
|
Pittsburgh Sleep Quality Index (PSQI)
|
11.8 units on a scale
STANDARD_DEVIATION 4.3 • n=138 Participants
|
12.3 units on a scale
STANDARD_DEVIATION 3.6 • n=62 Participants
|
12.0 units on a scale
STANDARD_DEVIATION 3.4 • n=123 Participants
|
|
Six-minute walk test
|
458.3 Meters
STANDARD_DEVIATION 146.6 • n=138 Participants
|
447.5 Meters
STANDARD_DEVIATION 145.8 • n=62 Participants
|
452.9 Meters
STANDARD_DEVIATION 146.2 • n=123 Participants
|
|
Patient Health Questionnaire (PHQ-9)
|
11.2 units on a scale
STANDARD_DEVIATION 4.8 • n=138 Participants
|
11.5 units on a scale
STANDARD_DEVIATION 5.5 • n=62 Participants
|
11.4 units on a scale
STANDARD_DEVIATION 5.1 • n=123 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPTSD symptoms over the previous month will be assessed with the CAPS-5 clinical interview. Total symptom severity score and symptom cluster severity scores will be calculated. Scores range from 0 to 80, with higher scores reflecting more severe PTSD symptoms.
Outcome measures
| Measure |
Exercise
n=25 Participants
Progressive, multi-component supervised exercise training group.
|
Healthy Aging Attention Control
n=29 Participants
A health education program that addresses topics relevant to older adults.
|
|---|---|---|
|
Clinician-Administered PTSD Scale for DSM-V (CAPS-5) Change Baseline to 6 Months
|
-4.96 units on a scale
Standard Deviation 10.1
|
-2.5 units on a scale
Standard Deviation 9.0
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 10 participants (n=2 Exercise; n=8 HAC) did not complete the 6-minute walk test at post-test and were not included in this analysis.
Performance-based measure of aerobic endurance. Participants are instructed to walk along a measured course for 6 minutes. The distance walked in 6 minutes is the outcome of this assessment. There is no maximum value for this test, but the minimum value could be 0 (unable to walk any distance).
Outcome measures
| Measure |
Exercise
n=23 Participants
Progressive, multi-component supervised exercise training group.
|
Healthy Aging Attention Control
n=21 Participants
A health education program that addresses topics relevant to older adults.
|
|---|---|---|
|
Six-minute Walk Test Change From Baseline to 6 Months
|
48.8 Meters
Standard Deviation 94.6
|
29.3 Meters
Standard Deviation 77.4
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 7 participants (n=5 Exercise; n=2 HAC) did not have complete data for the PHQ-9 at post-test and were not included in this analysis.
Self-report tool for assessing the severity of depression. Scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.
Outcome measures
| Measure |
Exercise
n=20 Participants
Progressive, multi-component supervised exercise training group.
|
Healthy Aging Attention Control
n=27 Participants
A health education program that addresses topics relevant to older adults.
|
|---|---|---|
|
Patient Health Questionnaire (PHQ-9) Change From Baseline to 6 Months
|
-2.0 units on a scale
Standard Deviation 4.6
|
0.3 units on a scale
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 13 participants (n=7 Exercise; n=6 HAC) did not have complete data for the PSQI at post-test and were not included in this analysis.
The PSQI is a self-report tool for assessing sleep quality and disturbance. Scores on the PSQI range from 0 to 21, with higher scores indicating poorer sleep quality.
Outcome measures
| Measure |
Exercise
n=18 Participants
Progressive, multi-component supervised exercise training group.
|
Healthy Aging Attention Control
n=23 Participants
A health education program that addresses topics relevant to older adults.
|
|---|---|---|
|
Pittsburgh Sleep Quality Index (PSQI) Change From Baseline to 6 Months
|
-2.8 units on a scale
Standard Deviation 2.8
|
-1.0 units on a scale
Standard Deviation 2.8
|
Adverse Events
Exercise
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Healthy Aging Attention Control
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Exercise
n=41 participants at risk
Progressive, multi-component supervised exercise training group.
|
Healthy Aging Attention Control
n=39 participants at risk
A health education program that addresses topics relevant to older adults.
|
|---|---|---|
|
Psychiatric disorders
Participant endorsed suicidal ideation on PHQ-9 survey during baseline or follow-up assessment.
|
29.3%
12/41 • Enrollment until end of follow-up (6 months)
When participants disclosed suicidal ideation on the PHQ-9 survey, the research team conducted our risk-assessment protocol to determine appropriate steps for responding and supporting participants. Some participants reported physical health symptoms during research exercise session prompting in-depth assessment by research team and follow-up with care team as indicated.
|
15.4%
6/39 • Enrollment until end of follow-up (6 months)
When participants disclosed suicidal ideation on the PHQ-9 survey, the research team conducted our risk-assessment protocol to determine appropriate steps for responding and supporting participants. Some participants reported physical health symptoms during research exercise session prompting in-depth assessment by research team and follow-up with care team as indicated.
|
|
Endocrine disorders
Hyperglycemia
|
2.4%
1/41 • Enrollment until end of follow-up (6 months)
When participants disclosed suicidal ideation on the PHQ-9 survey, the research team conducted our risk-assessment protocol to determine appropriate steps for responding and supporting participants. Some participants reported physical health symptoms during research exercise session prompting in-depth assessment by research team and follow-up with care team as indicated.
|
0.00%
0/39 • Enrollment until end of follow-up (6 months)
When participants disclosed suicidal ideation on the PHQ-9 survey, the research team conducted our risk-assessment protocol to determine appropriate steps for responding and supporting participants. Some participants reported physical health symptoms during research exercise session prompting in-depth assessment by research team and follow-up with care team as indicated.
|
|
General disorders
Lightheadedness during exercise
|
2.4%
1/41 • Enrollment until end of follow-up (6 months)
When participants disclosed suicidal ideation on the PHQ-9 survey, the research team conducted our risk-assessment protocol to determine appropriate steps for responding and supporting participants. Some participants reported physical health symptoms during research exercise session prompting in-depth assessment by research team and follow-up with care team as indicated.
|
0.00%
0/39 • Enrollment until end of follow-up (6 months)
When participants disclosed suicidal ideation on the PHQ-9 survey, the research team conducted our risk-assessment protocol to determine appropriate steps for responding and supporting participants. Some participants reported physical health symptoms during research exercise session prompting in-depth assessment by research team and follow-up with care team as indicated.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place