Exercise for Post-Traumatic Stress Disorder

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Christal Badour, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Christal L Badour

Must not be taking: Benzodiazepines, Stimulants

Disqualifiers: Severe substance use, Suicidal, Psychotic, Manic, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to test how exercise affects learning and memory processes relevant to the treatment of PTSD. Participants will complete a baseline intake followed by two experimental sessions. During the first experimental session, participants will undergo an MRI session of imaginal exposure to traumatic memory cues followed by 30-minutes of moderate intensity exercise or low intensity exercise. Participants will complete a second session of imaginal exposure with MRI 24 hours later.

Will I have to stop taking my current medications?

The trial requires that you do not have recent changes in psychiatric medication within the past 4 weeks, and you must be able to abstain from daily benzodiazepine or stimulant use during study sessions.

What data supports the effectiveness of the treatment Low Intensity Exercise, Low-Intensity Exercise, Light Exercise, Mild Exercise, Moderate Intensity Exercise, Aerobic Exercise, Physical Activity, Moderate Exercise for PTSD?

Research shows that exercise, including aerobic and physical activity, can reduce PTSD symptoms and improve related conditions like anxiety and depression. Studies found that exercise is safe, acceptable, and may lead to significant improvements in mental health for those with PTSD. ^{1 2 3 4 5}

Is exercise safe for people with PTSD?

Exercise, including aerobic and physical activity, is generally safe for people with PTSD. Studies show no adverse events and high adherence rates, indicating it is well-tolerated and can improve mental health without significant risks. ^{1 2 4 5 6}

How does exercise treatment for PTSD differ from other treatments?

Exercise treatment for PTSD is unique because it uses physical activity to reduce symptoms, potentially through mechanisms like improving brain function and reducing inflammation, unlike traditional treatments that often rely on medication or talk therapy. It can also improve related conditions like anxiety and depression, making it a versatile and accessible option for many individuals. ^{1 2 4 5 7}

Research Team

Thomas G Adams, Jr., PhD

Principal Investigator

University of Kentucky

Christal Badour, PhD

Principal Investigator

University of Kentucky

Eligibility Criteria

This trial is for adults with PTSD from interpersonal violence. It explores how different exercise intensities affect learning and memory tied to PTSD treatment.

Inclusion Criteria

I have PTSD from experiencing violence from others.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline and Experimental Sessions

Participants complete baseline intake and two experimental sessions involving imaginal exposure and exercise

1 week

3 visits (in-person)

Follow-up

Participants are monitored for changes in heart rate, BOLD response, and subjective emotional ratings

1 week

Treatment Details

Interventions

• Low Intensity Exercise (Behavioral Intervention)
• Moderate Intensity Exercise (Behavioral Intervention)

Trial Overview Participants will be exposed to traumatic memories, then do either moderate or low intensity exercise. Their brain activity is monitored via MRI before and after the exercises.

Participant Groups

Group I: Moderate Intensity Exercise Experimental Treatment 1 Intervention

Visit 1: Participants will complete study screening, PTSD assessments, and provide written narrative for a traumatic event and a neutral control event. Visit 2: Participants will complete baseline structural MRI scans before completing 8 trials of imaginal exposure - 4 neutral then 4 trauma narratives - with psychophysiological and fMRI measurement. Following completion of the imaginal exposure task, the participant will perform Moderate-Intensity Exercise (30-min at 70-75% max HR with 5-min warm-up and 5-min cool-down at 40-50% max HR), on a stationary bike. Visit 3: Participants will complete the same imaginal exposure with measurement of psychophysiology, fMRI, and subjective emotional responding.

Group II: Low Intensity Exercise Active Control 1 Intervention

Visit 1: Participants will complete study screening, PTSD assessments, and provide written narrative for a traumatic event and a neutral control event. Visit 2: Participants will complete baseline structural MRI scans before completing 8 trials of imaginal exposure - 4 neutral then 4 trauma narratives - with psychophysiological and fMRI measurement. Following completion of the imaginal exposure task, the participant will perform Low-Intensity Exercise (control; 40-mins at 40-50% max HR),on a stationary bike. Visit 3: Participants will complete the same imaginal exposure with measurement of psychophysiology, fMRI, and subjective emotional responding.

Who Is Running the Clinical Trial?

Christal L Badour

Lead Sponsor

Trials

3

Recruited

130+

Thomas Adams

Lead Sponsor

Trials

4

Recruited

180+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Dr. Joshua A. Gordon

National Institute of Mental Health (NIMH)

Chief Executive Officer since 2016

MD, PhD

Dr. Shelli Avenevoli

National Institute of Mental Health (NIMH)

Chief Medical Officer

PhD

University of Texas at Austin

Collaborator

Trials

387

Recruited

86,100+

Dr. Elly Barry

University of Texas at Austin

Chief Medical Officer

MD from Harvard Medical School

Dr. Brian Windsor

University of Texas at Austin

Chief Executive Officer since 2023

PhD in Molecular Biology from the University of Texas at Austin

Findings from Research

A pilot trial involving 54 veterans aged 60 and older with PTSD showed that supervised exercise training is safe and well-accepted, with high adherence rates of 82% and minimal attrition of 14%.

Participants experienced clinically significant improvements in PTSD symptoms and related conditions after 12 weeks of exercise, suggesting that exercise could be an effective intervention for older adults with PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot randomized controlled trial of exercise training for older veterans with PTSD. Hall, KS., Morey, MC., Bosworth, HB., et al.[2021]

A review of 19 studies suggests that aerobic exercise can effectively reduce PTSD symptoms, either on its own or alongside standard treatments.

Potential mechanisms for this improvement include helping individuals cope with internal stress cues, enhancing brain function, promoting neuroplasticity, normalizing stress hormone levels, and lowering inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Intervention in PTSD: A Narrative Review and Rationale for Implementation. Hegberg, NJ., Hayes, JP., Hayes, SM.[2023]

A 12-session aerobic exercise program significantly reduced symptoms of PTSD, anxiety, and depression in participants, indicating its potential as an effective intervention.

The positive effects of the exercise program were maintained for at least one month after the intervention, suggesting lasting benefits for individuals with treatment-resistant PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of an exercise program on posttraumatic stress disorder, anxiety, and depression. Manger, TA., Motta, RW.[2005]

A two-week aerobic exercise program involving 33 participants with PTSD led to clinically significant reductions in PTSD severity for 89% of the participants, indicating that aerobic exercise can be an effective treatment for PTSD symptoms.

While all exercise groups experienced reduced PTSD symptoms, those focusing on their bodily sensations during exercise showed less improvement compared to those who were distracted or had no specific focus, suggesting that distraction may enhance the therapeutic effects of exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aerobic Exercise Reduces Symptoms of Posttraumatic Stress Disorder: A Randomized Controlled Trial. Fetzner, MG., Asmundson, GJ.[2022]

Physical activity (PA) is an effective adjunct therapy for reducing PTSD symptoms, particularly in individuals with subsyndromal symptoms or those resistant to standard treatments, as highlighted by the review of existing literature.

There is a need for further research to determine the most effective types, doses, and durations of exercise for PTSD treatment, as findings from observational and controlled studies have been inconsistent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Physical Activity on PTSD. Oppizzi, LM., Umberger, R.[2019]

Aerobic exercise may serve as a beneficial addition to traditional PTSD treatments, like exposure therapy, by improving both physical health and enhancing the effectiveness of fear extinction learning, which is crucial for reducing anxiety symptoms.

The review highlights emerging evidence from preclinical and clinical studies that suggest exercise can improve the consolidation and recall of fear extinction memories, indicating a potential new approach to treating PTSD more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aerobic exercise in the treatment of PTSD: An examination of preclinical and clinical laboratory findings, potential mechanisms, clinical implications, and future directions. Crombie, KM., Adams, TG., Dunsmoor, JE., et al.[2023]

The Warrior Wellness pilot study aims to assess the feasibility and effectiveness of a 12-week exercise program for older veterans (aged 60 and above) with PTSD, focusing on improving PTSD symptoms and cardiovascular endurance.

This study will provide insights into how regular exercise can impact the health of older veterans with PTSD, potentially leading to better treatment options and improved quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Warrior Wellness Study: A Randomized Controlled Exercise Trial for Older Veterans with PTSD. Hall, KS., Morey, MC., Beckham, JC., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Pilot randomized controlled trial of exercise training for older veterans with PTSD. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Exercise Intervention in PTSD: A Narrative Review and Rationale for Implementation. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

The impact of an exercise program on posttraumatic stress disorder, anxiety, and depression. [2005]

4. England pubmed.ncbi.nlm.nih.gov

Aerobic Exercise Reduces Symptoms of Posttraumatic Stress Disorder: A Randomized Controlled Trial. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The Effect of Physical Activity on PTSD. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Aerobic exercise in the treatment of PTSD: An examination of preclinical and clinical laboratory findings, potential mechanisms, clinical implications, and future directions. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

The Warrior Wellness Study: A Randomized Controlled Exercise Trial for Older Veterans with PTSD. [2020]