Exercise: A Novel Treatment for Combat Post Traumatic Stress Disorder

Stopped early · Phase 2

Conditions studied: Post-Traumatic Stress Disorder

In brief

The primary objective of this pilot intervention study is to examine the efficacy of exercise for reducing the symptoms of posttraumatic stress disorder (PTSD) and other psychiatric and somatic symptoms. The sample will be composed of veterans aged 18-65 with combat-related PTSD (N = 40). Participants will be randomly assigned to one of two groups. Participants in the exercise training group (n = 20) will receive three 60-75 minute sessions per week of combination aerobic and resistance training for eight weeks. In the control stretching group, participants (n = 20) will receive training in whole-body flexibility three times per week for eight weeks. Secondary objectives include 1) determining feasibility of the intervention (as measured by the percentage of prescribed days of exercise completed by each participant, and percentage of time exercising completed at the prescribed intensity and duration); 2) determining the influence of exercise training on aerobic fitness and strength in the sample; and 3) determining whether psychiatric/somatic symptom improvements are associated with improvements in fitness and strength. Finally, exploratory objectives will include examining whether exercise training can improve early signs of heart disease, and whether certain biomarkers (using MRI and fMRI data and inflammatory markers) are associated with treatment response.

Key facts

Study ID

NCT01626131

Run by

INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium

People needed

11

Starts

2011-10-01

Expected to finish

2013-01-01

Last updated by the study team

2013-04-26

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ages 18-65yr
• Diagnosis of PTSD
• CAPS >30
• Reported combat exposure per the Deployment Risk and Resilience Inventory (DRRI)
• Sedentary lifestyle (planned activity for purpose of health < 2 days/wk)
• Capability of giving informed consent

You may not qualify if…

• Abuse of alcohol or drugs
• Homelessness
• Significant cognitive impairment (e.g., MMSE score of ≤ 26) that would hinder ability to understand the protocol
• Signs or symptoms of cardiovascular, metabolic or pulmonary disease that would preclude participating in the exercise, including uncontrolled hypertension (> 159/99 mm Hg)
• Usage of beta blockers, which could influence the heart rate response to exercise
• Any physical or mental health condition that would contraindicate participation in the study (e.g., musculoskeletal, orthopedic, and/or neuromuscular disorders)
• High suicidality
• Below cutoff on either STAI (<30) or PCL-M (<40)
• Pregnancy or plans to become pregnant in the next 4 months
• Excessive levels of physical activity assessed via interview and pedometer recording
• Current treatment for PTSD (drug or counseling) for a duration of less than eight weeks
• Clinically judged to be unsuitable for participation by the research physician

Where it is running

• 921 Assembly Street, 3rd Floor, Public Health Research Center, University of South Carolina — Columbia, South Carolina, United States

Full record on ClinicalTrials.gov

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