Improving Mind/Body Health and Functioning With Integrative Exercise

NCT02856412 | Completed Results

• 1 other identifier: D1939-R
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Disorders, Post-Traumatic

Keywords

Stress Disorders, Post-Traumatic; Exercise; Mindfulness

Outcome Measures

Primary Outcomes (2)

• Clinician Administered PTSD Scale (CAPS) Score Comparison Between Subjects Randomized to Integrative Exercise Treatment vs. Illness Management and Recovery

  The CAPS-5 is a 20 item scale that provides both a dimensional and categorical measure of PTSD. The CAPS-5 items are rated with a single severity score, ranging from 0-80 with higher scores indicating worse severity, 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).

  12 weeks

• The World Health Organization Quality of Life (WHOQOL-BREF) Score Comparison Between Subjects Randomized to Integrative Exercise Treatment vs. Monitor Only

  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 of the 6 items have 5 response options with higher scores indicating higher psychological health. The mean score of items within each domain is used to calculate the domain score. The domain score is then linearly transformed to scale of 0-100 to enable comparisons between other domains composed of unequal numbers of items. (Skevington et al. Quality of Life Research 13: 299-310, 2004.)

  12 weeks

Secondary Outcomes (6)

• Five Facet Mindfulness Questionnaire (FFMQ)- Observing

  12 weeks

• Godin Leisure-Time Exercise Questionnaire

  12 weeks

• PTSD Checklist for DSM-5 (PCL-5)

  12 weeks

• Symptom Check-List-90-Revised (SCL-90-R)

  12 weeks

• Pittsburgh Sleep Quality Index (PSQI)

  12 weeks

Study Arms (2)

Veterans Group Exercise

EXPERIMENTAL

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.

Other: Veterans Group Exercise (VGX)

Illness Management and Recovery

ACTIVE COMPARATOR

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.

Other: Illness Management and Recovery

Interventions

Veterans Group Exercise (VGX) OTHER

Integrative Exercise incorporates elements of strength training, flexibility, cardiovascular training, and controlled breathing exercises.

Also known as: VGX, Exercise Classes

Veterans Group Exercise

Illness Management and Recovery OTHER

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.

Also known as: IMR, Health Education Classes, PTSD Recovery Classes

Illness Management and Recovery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of California, San Francisco: collaborator

Study Sites (1)

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121, United States

Location

Related Publications (1)

• Neylan TC, Muratore LA, Williams CL, Schmitz M, Valdez CV, Maguen S, O'Donovan A, Kelley DP, Metzler TJ, Cohen BE, West AC, Phan JDV, Antonetti V, Mayzel O, Hlavin JA, Chesney MA, Mehling WE. Group integrated exercise versus recovery class for veterans with posttraumatic stress disorder: a randomized clinical trial. BMC Psychiatry. 2025 Feb 28;25(1):185. doi: 10.1186/s12888-025-06638-1.

  PMID: 40021975 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Motor Activity

Interventions

Salvage Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Thomas Neylan, MD
• Organization: San Francisco Veterans Health Care System

Thomas.Neylan@va.gov

415-750-6961

Study Officials

• Thomas C. Neylan, MD

  San Francisco VA Medical Center, San Francisco, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: August 4, 2016
• Study Start: September 4, 2017
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)