Exercise Training to Improve PTSD Symptoms and Health in Older Veterans

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

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.

Study Overview

• Status: Recruiting
• Conditions: Post-traumatic Stress Disorder
• Intervention / Treatment: Behavioral: Exercise Training; Other: Healthy Aging Attention Control (HA-ATC)

• Study Type: Interventional
• Enrollment (Estimated): 188
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katherine S Hall, PhD; Phone Number: 176734 (919) 286-0411; Email: katherine.hall3@va.gov

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705-3875
      • Recruiting
      • Durham VA Medical Center, Durham, NC
      • Sub-Investigator: Jean C Beckham, PhD
      • Principal Investigator: Katherine Shepherd Hall, PhD
      • Sub-Investigator: Miriam C. Morey, PhD
      • Contact: David Edelman, MD MHS; Phone Number: (919) 286-6936; Email: david.edelman@va.gov
      • Contact: Lisa J Eiben; Phone Number: (202) 382-2345; Email: Lisa.Eiben@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise; Progressive, multi-component supervised exercise training group.	Behavioral: Exercise Training; A multi-component group exercise intervention that emphasizes functional training. Duration is 6 months, and frequency is 3x per week.
Active Comparator: Healthy Aging Attention Control; A health education program that addresses topics relevant to older adults.	Other: 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.; Other Names: HA-ATC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician-Administered PTSD Scale for DSM-V (CAPS-5)	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.	6 months
Six-minute walk test	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).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire (PHQ-9)	Self-report tool for assessing the severity of depression. Scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.	6 months
Pittsburgh Sleep Quality Index (PSQI)	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.	6 months

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Katherine Shepherd Hall, PhD, Durham VA Medical Center, Durham, NC

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2021
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: December 11, 2019
• First Submitted That Met QC Criteria: December 11, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; Veterans; HRQOL; Aged; Physical performance
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: E3120-R; RX003120 (Other Grant/Funding Number: VAORD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

All of the individual participant data collected during the trial, after de-identification, will be made available.

A limited dataset (LDS) will be created and shared pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. Only de-identified (stripped of 18 HIPAA) and anonymized datasets (void of any identifying code, study or otherwise) will be shared.

• IPD Sharing Time Frame: Data will be made available immediately following publication. No end date.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No