N/A
N=84
Improving Mind/Body Health and Functioning With Integrative Exercise
Stress Disorders, Post-Traumatic
Bottom Line
View on ClinicalTrials.gov: NCT02856412 ↗Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Clinician Administered PTSD Scale (CAPS) Score Comparison Between Subjects Randomized to Integrative Exercise Treatment vs. Illness Management and Recovery — 24.4; 22.0 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Veterans Group Exercise (VGX) (Other); Illness Management and Recovery (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinician Administered PTSD Scale (CAPS) Score Comparison Between Subjects Randomized to Integrative Exercise Treatment vs. Illness Management and Recovery |
24.4; 22.0 | — |
| PRIMARY The World Health Organization Quality of Life (WHOQOL-BREF) Score Comparison Between Subjects Randomized to Integrative Exercise Treatment vs. Monitor Only |
41.5; 45.2 | — |
| SECONDARY Five Facet Mindfulness Questionnaire (FFMQ)- Observing |
22.2; 26.4 | — |
| SECONDARY Godin Leisure-Time Exercise Questionnaire |
44.2; 43.8 | — |
| SECONDARY PTSD Checklist for DSM-5 (PCL-5) |
36.3; 39.9 | — |
| SECONDARY Symptom Check-List-90-Revised (SCL-90-R) |
1.14; 1.13 | — |
| SECONDARY Pittsburgh Sleep Quality Index (PSQI) |
11.4; 10.7 | — |
| SECONDARY Insomnia Severity Index (ISI) |
13.6; 13.2 | — |
Summary
There is evidence demonstrating that aerobic exercise improves many symptoms of Posttraumatic Stress Disorder (PTSD) including; anxiety, depression, insomnia, and cognition. With the goal of using exercise as a rehabilitation therapy for Veterans with PTSD, a team of scientists and doctors developed a 12-week exercise program, combining aerobic and strength training with concentration training and mindful breathing techniques. The initial pilot study suggested that Integrative Exercise may improve overall quality of life, sleep quality, cardiovascular fitness, and PTSD symptoms. This new study will help determine the effectiveness of Integrative Exercise compared to health education classes. The overall goal is to determine if integrative exercise is an effective rehabilitation intervention for combat Veterans with PTSD.
Eligibility Criteria
Inclusion Criteria
- Veterans (Male and Female) between the ages of 18-75 who are physically able to participate in an exercise program
- Meet criteria for PTSD of at least 3 months duration, OR have some symptoms of PTSD with a current CAPS score of 23 or higher, as indexed by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Exclusion Criteria
- History of any psychiatric disorder with active psychosis or mania in the past 5 years
- Meet criteria for severe drug or alcohol use disorder within the past 6 months as assessed by the Structured Clinical Interview for DSM-5
- Prominent suicidal or homicidal ideation
- Currently exposed to recurrent trauma or have been exposed to a traumatic event within the past 3 months
- Pregnant
- Have a clinically significant:
- neurologic disorder
- systemic illness affecting central nervous system (CNS) function
- history of seizure disorder in the past 5 years
- and/or physical disabilities making it impossible to use exercise equipment
- Acute coronary events (i.e., Myocardial Infarction) in the past 6 months
- Moderate to severe Traumatic Brain Injury (any history of head trauma associated with the onset of persistent cognitive complaints, neurological symptoms, or loss of consciousness > 30 minutes)
- Subjects who, in the opinion of the investigator, are otherwise unsuitable for a study of this type
- The investigators will not exclude patients with PTSD who are currently receiving individual or group therapy or patients who are currently taking antidepressant or anti-anxiety medication, but will apply the following criteria:
- patients must have been in treatment for at least 2 months
- meet symptomatic criteria for inclusion
- do not have plans to discontinue treatment during the course of the trial
Data sourced from ClinicalTrials.gov (NCT02856412). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.