Exercise Training to Improve PTSD Symptoms and Health in Older Veterans (NCT04199182) | Clinical Trial Compass
CompletedNot Applicable
Exercise Training to Improve PTSD Symptoms and Health in Older Veterans
United States80 participantsStarted 2021-06-07
Plain-language 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. 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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.)
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinician-Administered PTSD Scale for DSM-V (CAPS-5) Change Baseline to 6 Months
Timeframe: 6 months
2
Six-minute Walk Test Change From Baseline to 6 Months