Exercise: A Novel Treatment for Combat Post Traumatic Stress Disorder
|ClinicalTrials.gov Identifier: NCT01626131|
Recruitment Status : Terminated (The funding agency, DoD, determined that the study could not meet its enrollment numbers by the end of the grant.)
First Posted : June 22, 2012
Last Update Posted : April 26, 2013
|Condition or disease||Intervention/treatment||Phase|
|Post-Traumatic Stress Disorder||Behavioral: exercise training Behavioral: Stretching training||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Exercise: A Novel Treatment for Combat PTSD|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
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.
- Efficacy as measured by a reduction in symptoms of posttraumatic stress disorder. [ Time Frame: from pre- to post-treatment during 8-week intervention. ]Efficacy will be determined by a reduction in posttraumatic stress disorder symptoms as measured by the Clinician-Administered PTSD Scale-2 (CAPS-2).
- Feasibility as measured by adherence to the intervention. [ Time Frame: during the 8-week 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.
- Efficacy as measured by improvements in strength and fitness. [ Time Frame: from pre- to post-treatment during 8-week intervention. ]Efficacy will be determined by improvements in strength and fitness. Fitness will be measured as graded maximal treadmill VO2max test performance.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01626131
|United States, South Carolina|
|921 Assembly Street, 3rd Floor, Public Health Research Center, University of South Carolina|
|Columbia, South Carolina, United States, 29208|
|Principal Investigator:||Shawn D. Youngstedt, Ph.D.||University of South Carolina|