Skip to main content
Clinical Trials/NCT04199182
NCT04199182
Completed
N/A

Exploring the Effects of Exercise Training on PTSD Symptoms and Physical Health in Older Veterans With PTSD

VA Office of Research and Development1 site in 1 country80 target enrollmentJune 7, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Post-traumatic Stress Disorder
Sponsor
VA Office of Research and Development
Enrollment
80
Locations
1
Primary Endpoint
Clinician-Administered PTSD Scale for DSM-V (CAPS-5)
Status
Completed
Last Updated
6 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 7, 2021
End Date
February 28, 2025
Last Updated
6 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Clinician-Administered PTSD Scale for DSM-V (CAPS-5)

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 sever PTSD symptoms.

Six-minute walk test

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 (feet) 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 Outcomes

  • Patient Health Questionnaire (PHQ-9)(6 months)
  • Pittsburgh Sleep Quality Index (PSQI)(6 months)

Study Sites (1)

Loading locations...

Similar Trials