Exercise Training to Improve PTSD Symptoms and Health in Older Veterans

Not Applicable

Completed

• Conditions: Post-traumatic Stress Disorder
• Interventions: Other: Healthy Aging Attention Control (HA-ATC); Behavioral: Exercise Training

• Registration Number: NCT04199182
• Lead Sponsor: VA Office of Research and Development

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-11
• Study First Submitted QC: 2019-12-11
• Study First Posted: 2019-12-13
• Study Start: 2021-06-07
• Primary Completion: 2024-09-30
• Study Completion: 2025-02-28
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Aging Attention Control	Healthy Aging Attention Control (HA-ATC)	A health education program that addresses topics relevant to older adults.
Exercise	Exercise Training	Progressive, multi-component supervised exercise training group.

Primary Outcome Measures

Name	Time	Method
Clinician-Administered PTSD Scale for DSM-V (CAPS-5)	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	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 Outcome Measures

Name	Time	Method
Patient Health Questionnaire (PHQ-9)	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)	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.

Trial Locations

Locations (1)

Durham VA Medical Center, Durham, NC; 🇺🇸 Durham, North Carolina, United States