Exercise: A Novel Treatment for Combat Post Traumatic Stress Disorder

NCT ID: NCT01626131

Last Updated: 2013-04-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Exercise treatment

Aerobic and resistance training

Group Type: EXPERIMENTAL

exercise training

Intervention Type: 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.

Stretching treatment

Group Type: EXPERIMENTAL

Stretching training

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

U.S. Army Medical Research and Development Command

FED

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shawn D. Youngstedt, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of South Carolina

Locations

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

Columbia, South Carolina, United States

Countries

United States

Other Identifiers

INTRuST-Exercise

Identifier Type: -

Identifier Source: org_study_id