Clinical trial NCT02856412: Improving Mind/Body Health and Functioning With Integrative Exercise
Official title: Improving Mind/Body Health and Functioning With Integrative Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Keywords: Stress Disorders, Post-Traumatic
Exercise
Mindfulness
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: University of California, San Francisco
First posted: 2016-08-04
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: Clinician Administered PTSD Scale (CAPS) Score Comparison Between Subjects Randomized to Integrative Exercise Treatment vs. Illness Management and Recovery
timeFrame: 12 weeks
measure: The World Health Organization Quality of Life (WHOQOL-BREF) Score Comparison Between Subjects Randomized to Integrative Exercise Treatment vs. Monitor Only
timeFrame: 12 weeks
Secondary outcomes:
measure: Five Facet Mindfulness Questionnaire (FFMQ)- Observing
timeFrame: 12 weeks
measure: Godin Leisure-Time Exercise Questionnaire
timeFrame: 12 weeks
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: 12 weeks
measure: Symptom Check-List-90-Revised (SCL-90-R)
timeFrame: 12 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 12 weeks
measure: Insomnia Severity Index (ISI)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center, San Francisco, CA
state: California
Study officials:
affiliation: San Francisco VA Medical Center, San Francisco, CA
name: Thomas C. Neylan, MD
role: PRINCIPAL_INVESTIGATOR
References: