Post-traumatic Stress Disorder
Conditions
Keywords
Physical performance, Veterans, Aged, Exercise, HRQOL
Brief 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.
Interventions
BEHAVIORALExercise Training
A multi-component group exercise intervention that emphasizes functional training. Duration is 6 months, and frequency is 3x per week.
OTHERHealthy Aging Attention Control (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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Behavioral intervention testing the effects of supervised exercise versus attention-control on PTSD symptoms and function.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician-Administered PTSD Scale for DSM-V (CAPS-5) Change Baseline to 6 Months | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire (PHQ-9) Change From Baseline to 6 Months | 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. |
| Pittsburgh Sleep Quality Index (PSQI) Change From Baseline to 6 Months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKatherine Shepherd Hall, PhD
Durham VA Medical Center, Durham, NC
Participant flow
Recruitment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 71.3 Years STANDARD_DEVIATION 4.3 |
| Clinician-Administered PTSD Scale for DSM-V (CAPS-5) | 27.4 units on a scale STANDARD_DEVIATION 9.32 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 77 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Patient Health Questionnaire (PHQ-9) | 11.5 units on a scale STANDARD_DEVIATION 5.5 |
| Pittsburgh Sleep Quality Index (PSQI) | 11.8 units on a scale STANDARD_DEVIATION 4.3 |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 67 Participants |
| Six-minute walk test | 452.9 Meters STANDARD_DEVIATION 146.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 39 |
| other Total, other adverse events | 14 / 41 | 6 / 39 |
| serious Total, serious adverse events | 0 / 41 | 0 / 39 |
Outcome results
None listed