Clinical trial NCT04199182: Exercise Training to Improve PTSD Symptoms and Health in Older Veterans
Official title: Exploring the Effects of Exercise Training on PTSD Symptoms and Physical Health in Older Veterans With PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-traumatic Stress Disorder
Keywords: Physical performance
Veterans
Aged
Exercise
HRQOL
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2019-12-13
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Behavioral intervention testing the effects of supervised exercise versus attention-control on PTSD symptoms and function.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Clinician-Administered PTSD Scale for DSM-V (CAPS-5)
timeFrame: 6 months
measure: Six-minute walk test
timeFrame: 6 months
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 6 months
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 6 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Katherine Shepherd Hall, PhD
role: PRINCIPAL_INVESTIGATOR
References: