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Exercise: A Novel Treatment for Combat Post Traumatic Stress Disorder

Primary Purpose

Post-Traumatic Stress Disorder

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
exercise training
Stretching training
Sponsored by
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring combat disorders, exercise therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Exercise treatment

Stretching treatment

Arm Description

Aerobic and resistance training

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.

Full Information

First Posted
June 20, 2012
Last Updated
April 24, 2013
Sponsor
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
Collaborators
U.S. Army Medical Research and Development Command
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1. Study Identification

Unique Protocol Identification Number
NCT01626131
Brief Title
Exercise: A Novel Treatment for Combat Post Traumatic Stress Disorder
Official Title
Exercise: A Novel Treatment for Combat PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Terminated
Why Stopped
The funding agency, DoD, determined that the study could not meet its enrollment numbers by the end of the grant.
Study Start Date
October 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
Collaborators
U.S. Army Medical Research and Development Command

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder
Keywords
combat disorders, exercise therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise treatment
Arm Type
Experimental
Arm Description
Aerobic and resistance training
Arm Title
Stretching treatment
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
exercise training
Intervention Description
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
Intervention Name(s)
Stretching training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Efficacy as measured by a reduction in symptoms of posttraumatic stress disorder.
Description
Efficacy will be determined by a reduction in posttraumatic stress disorder symptoms as measured by the Clinician-Administered PTSD Scale-2 (CAPS-2).
Time Frame
from pre- to post-treatment during 8-week intervention.
Secondary Outcome Measure Information:
Title
Feasibility as measured by adherence to the intervention.
Description
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.
Time Frame
during the 8-week intervention
Title
Efficacy as measured by improvements in strength and fitness.
Description
Efficacy will be determined by improvements in strength and fitness. Fitness will be measured as graded maximal treadmill VO2max test performance.
Time Frame
from pre- to post-treatment during 8-week intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shawn D. Youngstedt, Ph.D.
Organizational Affiliation
University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
921 Assembly Street, 3rd Floor, Public Health Research Center, University of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29208
Country
United States

12. IPD Sharing Statement

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Exercise: A Novel Treatment for Combat Post Traumatic Stress Disorder

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