Exercise: A Novel Treatment for Combat Post Traumatic Stress Disorder

NCT01626131 | Terminated Phase 2 DMC

• 1 other identifier: INTRuST-Exercise
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-Traumatic Stress Disorder

Keywords

combat disorders; exercise therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Feasibility as measured by adherence to the intervention.

  during the 8-week intervention

• Efficacy as measured by improvements in strength and fitness.

  from pre- to post-treatment during 8-week intervention.

Study Arms (2)

Exercise treatment

EXPERIMENTAL

Aerobic and resistance training

Behavioral: exercise training

Stretching treatment

EXPERIMENTAL

Behavioral: Stretching training

Interventions

exercise training BEHAVIORAL

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.

Exercise treatment

Stretching training BEHAVIORAL

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.

Stretching treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium: lead
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (1)

921 Assembly Street, 3rd Floor, Public Health Research Center, University of South Carolina

Columbia, South Carolina, 29208, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Combat Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Shawn D. Youngstedt, Ph.D.

  University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2012
• First Posted: June 22, 2012
• Study Start: October 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: April 26, 2013

Record last verified: 2013-04

Locations

US (1)