Improving Mind/Body Health and Functioning With Integrative Exercise

Completed · Not applicable

Conditions studied: Stress Disorders, Post-Traumatic

In brief

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.

Key facts

Study ID

NCT02856412

Run by

VA Office of Research and Development

People needed

84

Starts

2017-09-04

Expected to finish

2023-02-01

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• San Francisco VA Medical Center, San Francisco, CA — San Francisco, California, United States

Full record on ClinicalTrials.gov

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