Exercise Training to Improve PTSD Symptoms and Health in Older Veterans

NCT04199182 | Completed Results

• 2 other identifiers: E3120-RRX003120
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-traumatic Stress Disorder

Keywords

Physical performance; Veterans; Aged; Exercise; HRQOL

Outcome Measures

Primary Outcomes (2)

• Clinician-Administered PTSD Scale for DSM-V (CAPS-5) Change Baseline to 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.

  6 months

• Six-minute Walk Test Change From Baseline to 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).

  6 months

Secondary Outcomes (2)

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

  6 months

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

  6 months

Study Arms (2)

Exercise

EXPERIMENTAL

Progressive, multi-component supervised exercise training group.

Behavioral: Exercise Training

Healthy Aging Attention Control

ACTIVE COMPARATOR

A health education program that addresses topics relevant to older adults.

Other: Healthy Aging Attention Control (HA-ATC)

Interventions

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.

Also known as: HA-ATC

Healthy Aging Attention Control

Exercise Training BEHAVIORAL

A multi-component group exercise intervention that emphasizes functional training. Duration is 6 months, and frequency is 3x per week.

Exercise

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr. Katherine Hall
• Organization: Durham VA HCS

katherine.hall3@va.gov

9192860411

Study Officials

• Katherine Shepherd Hall, PhD

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Behavioral intervention testing the effects of supervised exercise versus attention-control on PTSD symptoms and function.

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 13, 2019
• Study Start: June 7, 2021
• Primary Completion: February 10, 2025
• Study Completion: February 28, 2025
• Last Updated: March 25, 2026
• Results First Posted: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available immediately following publication. No end date.
• Access Criteria: Requests for de-identified meta-data will be considered by the PI, under a data-sharing agreement that includes: 1) a commitment to using the data only for research purposes; 2) a commitment to securing data using appropriate digital technology; and 3) a commitment to destroying or returning the data after analyses are complete. Data access will be provided only to qualified researchers, with a methodologically sound proposal, fully consistent with the VA/NIH data sharing policies and applicable laws and regulations.

Locations

US (1)