Improving Mind/Body Health and Functioning With Integrative Exercise



Status:Recruiting
Conditions:Psychiatric, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 75
Updated:1/13/2019
Start Date:September 4, 2017
End Date:September 30, 2021
Contact:Thomas C Neylan, MD
Email:Thomas.Neylan@va.gov
Phone:(415) 750-6961

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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.

Despite the considerable efforts of the VA to improve awareness of mental health problems and
access to care, many returning Veterans still report substantial barriers to seeking
traditional mental health care. There is a large body of evidence demonstrating that aerobic
exercise effectively improves many outcomes relevant to Posttraumatic Stress Disorder (PTSD)
including; anxiety, depression, insomnia, cognition, and cardiovascular disease. In addition,
there is a rapidly growing evidence base showing that aerobic exercise produces an increase
in the growth of new neurons (e.g., neurogenesis) and increases the volume of the hippocampus
which underscores the potential value of exercise for producing broad benefits to
psychological health. Recognizing the promise that exercise might hold for attracting more
Veterans into care and improving overall health in Veterans with PTSD, a team of
investigators at the San Francisco Veterans Administration Medical Center (SFVAMC) with
funding from the Department of Defense developed a treatment protocol and completed a pilot
study of Integrative Exercise (Aerobic exercise and Breath Training 3 weekly sessions over 12
weeks) versus a waitlist control condition. Promising results from this trial have led us to
the next step which is to conduct a definitive efficacy study of Integrative Exercise versus
an active health education control condition: Illness Management and Recovery (IMR). The
control condition will be matched on contact hours with treatment personnel. The goal of this
revised proposal is to test if Integrative Exercise improves overall quality of life, PTSD
symptoms, sleep quality, and measures of cardiovascular health in combat Veterans with
chronic PTSD relative to the IMR condition. Another goal is to test if improvements in
quality of life are predicted by improvements in cardiovascular fitness as measured by
exercise capacity on treadmill testing. Finally, the proposal will test if Integrative
Exercise versus IMR will produce greater improvements in additional health outcomes,
including mood, subjective sleep quality, and PTSD symptoms.

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:

- Lifetime history of any psychiatric disorder with psychotic features in the past 5
years:

- bipolar disorder

- mania

- meet criteria for severe drug or alcohol use disorder within the past year 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

- Contraindications for the exercise treadmill test, which includes any 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
We found this trial at
1
site
San Francisco, California 94121
Principal Investigator: Thomas C. Neylan, MD
Phone: 415-221-4810
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San Francisco, CA
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