Exercise: A Novel Treatment for Combat Post Traumatic Stress Disorder

Exercise: A Novel Treatment for Combat PTSD

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.

Study Overview

• Status: Terminated
• Conditions: Post-Traumatic Stress Disorder
• Intervention / Treatment: Behavioral: exercise training; Behavioral: Stretching training

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Columbia, South Carolina, United States, 29208
      • 921 Assembly Street, 3rd Floor, Public Health Research Center, University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise treatment; Aerobic and resistance training	Behavioral: exercise training; 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.
Experimental: Stretching treatment	Behavioral: Stretching training; 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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
• Collaborators: U.S. Army Medical Research and Development Command
• Investigators: Principal Investigator: Shawn D. Youngstedt, Ph.D., University of South Carolina

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: June 20, 2012
• First Submitted That Met QC Criteria: June 21, 2012
• First Posted (Estimate): June 22, 2012

Study Record Updates

• Last Update Posted (Estimate): April 26, 2013
• Last Update Submitted That Met QC Criteria: April 24, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: exercise therapy; combat disorders
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: INTRuST-Exercise