Exercise Training to Improve PTSD Symptoms and Health in Older Veterans

NCT ID: NCT04199182

Last Updated: 2025-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-07
• Study Completion Date: 2025-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Exercise

Progressive, multi-component supervised exercise training group.

Group Type: EXPERIMENTAL

Exercise Training

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Healthy Aging Attention Control (HA-ATC)

Intervention Type: 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.

Interventions

Exercise Training

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

Intervention Type: BEHAVIORAL

Healthy Aging Attention Control (HA-ATC)

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.

Intervention Type: OTHER

Other Intervention Names

HA-ATC

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
• hospitalization or ER visit in the past 6 months for conditions contraindicated for exercise (cardiac event; physical trauma)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katherine Shepherd Hall, PhD

Role: PRINCIPAL_INVESTIGATOR

Durham VA Medical Center, Durham, NC

Locations

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

RX003120

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

E3120-R

Identifier Type: -

Identifier Source: org_study_id