Exercise: A Novel Treatment for Combat Post Traumatic Stress Disorder

Post-Traumatic Stress Disorder Clinical Trial

Official title:

Exercise: A Novel Treatment for Combat PTSD

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01626131
• Other study ID #: INTRuST-Exercise
• Status: Terminated
• Phase: Phase 2
• First received: June 20, 2012
• Last updated: April 24, 2013
• Start date: October 2011
• Est. completion date: January 2013

Study information

• Verified date: April 2013
• Source: INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	921 Assembly Street, 3rd Floor, Public Health Research Center, University of South Carolina	Columbia	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium	U.S. Army Medical Research and Materiel Command

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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	No
Secondary	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.	No