Improving Mind/Body Health and Functioning With Integrative Exercise

NCT ID: NCT02856412

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-04
• Study Completion Date: 2023-02-01

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.

Conditions

Stress Disorders, Post-Traumatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Veterans Group Exercise (VGX)

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Illness Management and Recovery

Intervention Type: 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.

Interventions

Veterans Group Exercise (VGX)

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

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

VGX, Exercise Classes; IMR, Health Education Classes, PTSD Recovery Classes

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas C. Neylan, MD

Role: PRINCIPAL_INVESTIGATOR

San Francisco VA Medical Center, San Francisco, CA

Locations

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40021975 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

D1939-R

Identifier Type: -

Identifier Source: org_study_id