Exercise Training to Improve PTSD Symptoms and Health in Older Veterans

Post-traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04199182
• Other study ID #: E3120-R
• Secondary ID: RX003120
• Status: Recruiting
• Phase: N/A
• Start date: June 7, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: February 2024
• Source: VA Office of Research and Development
• Contact: Katherine S Hall, PhD
• Phone: (919) 286-0411
• Email: katherine.hall3[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 188
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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

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.

Locations

Country	Name	City	State
United States	Durham VA Medical Center, Durham, NC	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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