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Exercise Training to Improve PTSD Symptoms and Health in Older Veterans

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VA Office of Research and Development

Status

Completed

Conditions

Post-traumatic Stress Disorder

Treatments

Behavioral: Exercise Training
Other: Healthy Aging Attention Control (HA-ATC)

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT04199182
RX003120 (Other Grant/Funding Number)
E3120-R

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

80 participants in 2 patient groups

Exercise
Experimental group
Description:
Progressive, multi-component supervised exercise training group.
Treatment:
Behavioral: Exercise Training
Healthy Aging Attention Control
Active Comparator group
Description:
A health education program that addresses topics relevant to older adults.
Treatment:
Other: Healthy Aging Attention Control (HA-ATC)

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Katherine S Hall, PhD

Data sourced from clinicaltrials.gov

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