Post-traumatic Stress DisorderNCT04199182
Exercise Training to Improve PTSD Symptoms and Health in Older Veterans
A study testing Exercise Training in people with Post-traumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Posttraumatic stress disorder (PTSD) is prevalent among military Veterans and is more than just a psychological condition; PTSD has profound negative impacts on health, function, and quality of life. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Post-traumatic Stress Disorder
- What is being tested?
- Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2021to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Veteran status
- registered for care at Durham VA Health Care System (VAHCS)
- live within 50 miles of fitness facility
- meet diagnostic criteria for PTSD as assessed by the CAPS-5
Who cannot join
- history of any psychiatric disorder with severe psychotic features in the past 5 years (e.g., bipolar disorder, mania), as indicated by ICD-10 codes F20-F29 (ICD-9 category 298.9)
- prominent suicidal ideation or hospitalization for suicidality in the previous 6 months
- clinically significant: neurological disorder, systemic illness affecting central nervous system (CNS) function, or history of seizure disorder in the past 5 years
- uncontrolled diabetes defined as:
- Abnormal fasting plasma glucose 126 mg/dL, random plasma glucose 200 mg/dL
- no active medications for diabetes management (Metformin, insulin, etc.)
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- no clinical notes in the patient's electronic health record (EHR) indicating monitoring by primary care physician (PCP) or Endo for diabetes management)
- end stage liver disease or currently receiving dialysis
- physical disabilities precluding use of exercise equipment (assistive mobility devices acceptable)
- significant cognitive impairment or diagnosis of Alzheimer's Disease or Dementia
- hospitalization or ER visit in the past 6 months for conditions contraindicated for exercise (cardiac event; physical trauma)
Trial locations and contacts
1 site in 1 country.
United States1 site
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
About this study
Official title: Exploring the Effects of Exercise Training on PTSD Symptoms and Physical Health in Older Veterans With PTSD
Posttraumatic stress disorder (PTSD) is prevalent among military Veterans and is more than just a psychological condition; PTSD has profound negative impacts on health, function, and quality of life. Older Veterans are the largest patient population served by the Veterans Health Administration (VHA), and many have lived with PTSD for 40+ years. Veterans with PTSD engage in low levels of physical activity and spend much of their time in sedentary activities, adding to their risk of physical disability. The benefits of exercise on mental health and physical well-being in older adults are well-substantiated, but the effects of exercise training on late-life PTSD symptoms is a new area of study. This study is designed to examine the effects of 6 months of supervised exercise training on PTSD symptoms and PTSD-related conditions (e.g., functional impairment, sleep) in 188 older Veterans with PTSD.
- Conditions
- Post-traumatic Stress Disorder
- Being tested
- Exercise Training, Healthy Aging Attention Control (HA-ATC)
- Keywords
- Physical performance, Veterans, Aged, Exercise, HRQOL
- Medical subject headings
- Stress Disorders, Post-Traumatic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TrainingBehavioural
A multi-component group exercise intervention that emphasizes functional training. Duration is 6 months, and frequency is 3x per week.
Healthy Aging Attention Control (HA-ATC)Other
Also called HA-ATC
Participants in the HA-ATC group will receive a health education program modeled on the "10 Keys to Healthy Aging" curriculum and the National Council on Aging's "Aging Mastery Program." HA-ATC will include an 8-week face-to-face group program followed by bi-weekly sessions for the remaining 4 months.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Progressive, multi-component supervised exercise training group. Receives: Behavioral: Exercise Training |
| Healthy Aging Attention Control | Active comparator | A health education program that addresses topics relevant to older adults. Receives: Other: Healthy Aging Attention Control (HA-ATC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician-Administered PTSD Scale for DSM-V (CAPS-5) Change Baseline to 6 Months
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.
Measured: 6 months
Six-minute Walk Test Change From Baseline to 6 Months
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).
Measured: 6 months
Secondary outcomes (2)
Patient Health Questionnaire (PHQ-9) Change From Baseline to 6 Months
Self-report tool for assessing the severity of depression. Scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.
Measured: 6 months
Pittsburgh Sleep Quality Index (PSQI) Change From Baseline to 6 Months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start7 Jun 2021
- Primary completion10 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Behavioral intervention testing the effects of supervised exercise versus attention-control on PTSD symptoms and function.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Katherine Shepherd Hall, PhD, Principal investigator, Durham VA Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199182
- Sponsor's protocol ID
- E3120-R
- Other IDs
- RX003120
- Status last verified
- Mar 2026
- First submitted
- 11 Dec 2019
- Last updated
- 25 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after de-identification, will be made available. A limited dataset (LDS) will be created and shared pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. Only de-identified (stripped of 18 HIPAA) and anonymized datasets (void of any identifying code, study or otherwise) will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effects of Exercise Training on PTSD Symptoms and Physical Health in Older Veterans With PTSD
- ClinicalTrials.gov ID
- NCT04199182
- Acronym / sponsor ID
- E3120-R
- Conditions
- Post-traumatic Stress Disorder
- Keywords
- Physical performance, Veterans, Aged, Exercise, HRQOL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 10 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 13 Dec 2019 (actual)
- Results
- Posted 25 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Posttraumatic stress disorder (PTSD) is prevalent among military Veterans and is more than just a psychological condition; PTSD has profound negative impacts on health, function, and quality of life. Older Veterans are the largest patient population served by the Veterans Health Administration (VHA), and many have lived with PTSD for 40+ years. Veterans with PTSD engage in low levels of physical activity and spend much of their time in sedentary activities, adding to their risk of physical disability. The benefits of exercise on mental health and physical well-being in older adults are well-substantiated, but the effects of exercise training on late-life PTSD symptoms is a new area of study. This study is designed to examine the effects of 6 months of supervised exercise training on PTSD symptoms and PTSD-related conditions (e.g., functional impairment, sleep) in 188 older Veterans with PTSD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Behavioral intervention testing the effects of supervised exercise versus attention-control on PTSD symptoms and function.
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Exercise TrainingProgressive, multi-component supervised exercise training group. |
| Healthy Aging Attention Control | Active comparator | Other: Healthy Aging Attention Control (HA-ATC)A health education program that addresses topics relevant to older adults. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Veteran status
- registered for care at Durham VA Health Care System (VAHCS)
- live within 50 miles of fitness facility
- meet diagnostic criteria for PTSD as assessed by the CAPS-5
Key exclusion criteria (11 listed)
- history of any psychiatric disorder with severe psychotic features in the past 5 years (e.g., bipolar disorder, mania), as indicated by ICD-10 codes F20-F29 (ICD-9 category 298.9)
- prominent suicidal ideation or hospitalization for suicidality in the previous 6 months
- clinically significant: neurological disorder, systemic illness affecting central nervous system (CNS) function, or history of seizure disorder in the past 5 years
- uncontrolled diabetes defined as:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise TrainingA multi-component group exercise intervention that emphasizes functional training. Duration is 6 months, and frequency is 3x per week. | Behavioural | Exercise |
| Healthy Aging Attention Control (HA-ATC)Also: HA-ATCParticipants in the HA-ATC group will receive a health education program modeled on the "10 Keys to Healthy Aging" curriculum and the National Council on Aging's "Aging Mastery Program." HA-ATC will include an 8-week face-to-face group program followed by bi-weekly sessions for the remaining 4 months. | Other | Healthy Aging Attention Control |
Primary outcome
Clinician-Administered PTSD Scale for DSM-V (CAPS-5) Change Baseline to 6 Months
Time frame: 6 months
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.
Six-minute Walk Test Change From Baseline to 6 Months
Time frame: 6 months
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).
2 secondary outcomes
Patient Health Questionnaire (PHQ-9) Change From Baseline to 6 Months
Time frame: 6 months
Pittsburgh Sleep Quality Index (PSQI) Change From Baseline to 6 Months
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after de-identification, will be made available. A limited dataset (LDS) will be created and shared pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. Only de-identified (stripped of 18 HIPAA) and anonymized datasets (void of any identifying code, study or otherwise) will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Shepherd Hall, PhD principal investigator
Durham VA Medical Center, Durham, NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Training in people with Post-traumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician-Administered PTSD Scale for DSM-V (CAPS-5) Change Baseline to 6 Months (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.