Exercise: A Novel Treatment for Combat Post Traumatic Stress Disorder

Study Overview
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Brief Summary
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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.

Official Title
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Exercise: A Novel Treatment for Combat PTSD

Conditions
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Post-Traumatic Stress Disorder

Intervention / Treatment
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* Behavioral: exercise training
* Behavioral: Stretching training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise treatment<br>Aerobic and resistance training | Behavioral: exercise training<br>* Participants will engage in 3 aerobic and resistance exercise sessions ( 60-75 min total per session) weekly for 8 consecutive weeks. Aerobic exercise will be performed for 30 minutes on a treadmill 3 times weekly. Before beginning, 10 min of stretches will be performed. Each exercise bout will begin and end with a 5-min warm-up and 5-min cool-down on the treadmill, not included in the prescribed exercise duration. Eight resistance exercises will be performed immediately following the aerobic exercise: lat pulldown, triceps pushdown, seated chest press, upright row, bicep curls, leg press, shoulder press, and abdominal crunches. Participants will perform two sets of 10 repetitions of each. A rest interval of 60 seconds will be taken between exercises. Research staff will initially assist the participants in choosing the proper resistance to use, and weight will be increased once 15 repetitions can be performed while maintaining proper form.<br>|
| Experimental: Stretching treatment<br> | Behavioral: Stretching training<br>* Participants will engage in stretching sessions that will focus on whole-body flexibility. Participants will perform 3 sessions per week ( 60 min) of 3 sets of 14 stretches focused on the muscle groups targeted by the exercise training (i.e., deltoids, pectorals, lats, forearms and biceps, triceps, quadriceps, hamstrings, and groins). Each stretch will be performed for 20 seconds and a rest interval of 60 seconds will be taken between each set.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy as measured by a reduction in symptoms of posttraumatic stress disorder. | Efficacy will be determined by a reduction in posttraumatic stress disorder symptoms as measured by the Clinician-Administered PTSD Scale-2 (CAPS-2). | from pre- to post-treatment during 8-week intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility as measured by adherence to the intervention. | Feasibility will be determined by adherence to the intervention as measured by participation ≥ 2 times per week at the prescribed intensity for ≥ 80% of the exercise bouts. | during the 8-week intervention | 
| Efficacy as measured by improvements in strength and fitness. | Efficacy will be determined by improvements in strength and fitness. Fitness will be measured as graded maximal treadmill VO2max test performance. | from pre- to post-treatment during 8-week intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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combat disorders, exercise therapy