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Completed

NCT Number: NCT04199182

Exercise Training to Improve PTSD Symptoms and Health in Older Veterans

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.

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Key information

Conditions

Post-traumatic Stress Disorder Behavior Mental Disorders Motor Activity Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Exercise Training

Behavioral

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

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.

Other names: HA-ATC

Primary outcomes

  1. 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.

  2. 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).

Secondary outcomes

  1. Patient Health Questionnaire (PHQ-9) Change From Baseline to 6 Months

    Time frame: 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.

  2. Pittsburgh Sleep Quality Index (PSQI) Change From Baseline to 6 Months

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Dec 13, 2019
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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