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Improving Mind/Body Health and Functioning With Integrative Exercise

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02856412
Recruitment Status : Recruiting
First Posted : August 4, 2016
Last Update Posted : November 14, 2019
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE August 2, 2016
First Posted Date  ICMJE August 4, 2016
Last Update Posted Date November 14, 2019
Actual Study Start Date  ICMJE September 4, 2017
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 2, 2016)
  • Clinician Administered PTSD Scale (CAPS) score comparison between subjects randomized to Integrative Exercise Treatment vs. Illness Management and Recovery [ Time Frame: 12 weeks ]
    The CAPS-5 is a 30 item scale that provides both a dimensional and categorical measure of PTSD. The CAPS-5 items are rated with a single severity score that incorporates both frequency and intensity PTSD-related symptoms. In addition to assessing the 20 DSM-5 PTSD symptoms, questions target the onset and duration of symptoms, subjective distress, impact of symptoms on social and occupational functioning, improvement in symptoms since a previous CAPS administration, overall response validity, overall PTSD severity, and specifications for the dissociative subtype (depersonalization and derealization).
  • The World Health Organization Quality of Life (WHOQOL-BREF) score comparison between subjects randomized to Integrative Exercise Treatment vs. Monitor Only [ Time Frame: 12 weeks ]
    The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original WHOQOL-100 instrument and is more convenient for use in large research studies or clinical trials. The Psychological Domain, the investigators' primary outcome, is derived from 6 items which index body image, negative & positive feelings, self-esteem, spirituality, and cognition. Each item has 5 response options with higher scores denoting higher psychological health. The mean score of items within each domain is used to calculate the domain score. Mean scores are then multiplied by 4 in order to make transformed domain scores to a range of 4-20 comparable with the scores used in the WHOQOL-100.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2016)
  • Five Facet Mindfulness Questionnaire (FFMQ) [ Time Frame: 12 weeks ]
    The FFMQ is a 39-item questionnaire derived from a factor analysis of other mindfulness questionnaires. It assesses five facets of mindfulness: observing, describing, acting with awareness, non-judging and non-reactivity to inner experience which represent elements of mindfulness as it is currently conceptualized. Items are rated on a Likert scale ranging from 1 (never or very rarely true) to 5 (very often or always true).
  • The Physical Activity Self-Efficacy scale (PASE) [ Time Frame: 12 weeks ]
    The PASE will be used as an exploratory measure of perceived confidence to continue exercising in the face of competing day-to-day conditions.
  • Godin Leisure-Time Exercise Questionnaire [ Time Frame: 12 weeks ]
    The Godin Leisure-Time Exercise Questionnaire is a validated brief inventory assessing sedentary, work, recreational, and aerobic activity in a typical week.
  • PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: 12 weeks ]
    The PCL-5 is a validated self-report rating scale for assessing PTSD symptoms. It consists of 20 items that correspond to the DSM-5 symptoms of PTSD.
  • Symptom Check-List-90-Revised (SCL-90-R) [ Time Frame: 12 weeks ]
    The SCL-90-R is a standard self-report measure of general psychopathology.
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 12 weeks ]
    This self-report measure provides a subjective assessment of sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances (including nightmares), use of sedative-hypnotics, and daytime energy.
  • PSQI- PTSD Addendum (PSQI-A) [ Time Frame: 12 weeks ]
    The PSQI-A assesses disruptive nocturnal behaviors related to PTSD, such as hot flashes, nightmares, and episodes of terror during sleep.
  • Insomnia Severity Index (ISI) [ Time Frame: 12 weeks ]
    The ISI is a self-report measure that is a more specific index of perceived insomnia severity, as compared to the widely used PSQI measure which captures sleep disturbances of all types.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Mind/Body Health and Functioning With Integrative Exercise
Official Title  ICMJE Improving Mind/Body Health and Functioning With Integrative Exercise
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stress Disorders, Post-Traumatic
Intervention  ICMJE
  • Other: Veterans Group Exercise (VGX)
    Integrative Exercise incorporates elements of strength training, flexibility, cardiovascular training, and controlled breathing exercises.
    Other Name: VGX, Exercise Classes
  • Other: Illness Management and Recovery
    Illness Management and Recovery is an educational program focused on helping individuals more effectively manage their illnesses to pursue their personal recovery goals. The classes include the following topic areas which have been adapted for use in PTSD: recovery, practical facts about PTSD, stress-vulnerability, building social support, medications for PTSD, drug and alcohol use, reducing relapse, coping with stress, coping with persistent symptoms, getting needs met in the VA healthcare system, and living a healthy lifestyle.
    Other Name: IMR, Health Education Classes, PTSD Recovery Classes
Study Arms  ICMJE
  • Experimental: Veterans Group Exercise
    Exercise 3 times weekly (for 12 weeks), with each total workout lasting approximately 60 minutes. Integrative Exercise incorporates elements of strength training, flexibility, cardiovascular training, and controlled breathing exercises.
    Intervention: Other: Veterans Group Exercise (VGX)
  • Active Comparator: Illness Management and Recovery
    Attend 3 health education classes weekly (for 12 weeks), with each class lasting approximately 60 minutes. Illness Management and Recovery is an educational program focused on helping individuals more effectively manage their illnesses to pursue their personal recovery goals. The classes include the following topic areas which have been adapted for use in PTSD: recovery, practical facts about PTSD, stress-vulnerability, building social support, medications for PTSD, drug and alcohol use, reducing relapse, coping with stress, coping with persistent symptoms, getting needs met in the VA healthcare system, and living a healthy lifestyle.
    Intervention: Other: Illness Management and Recovery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 2, 2016)
104
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2021
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Thomas C Neylan, MD (415) 750-6961 Thomas.Neylan@va.gov
Contact: Jennifer A Hlavin, MS (415) 221-4810 ext 6624 jennifer.hlavin@va.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02856412
Other Study ID Numbers  ICMJE D1939-R
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE University of California, San Francisco
Investigators  ICMJE
Principal Investigator: Thomas C. Neylan, MD San Francisco VA Medical Center, San Francisco, CA
PRS Account VA Office of Research and Development
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP