What side effects are associated with this type of intervention?

The most common treatments for PTSD include serotonin reuptake inhibitors (SSRIs and SNRIs), prazosin, and cognitive behavioral therapy (CBT). SSRIs and SNRIs can cause side effects such as nausea, insomnia, sexual dysfunction, and increased anxiety. Prazosin, used primarily for sleep disturbances and nightmares, may lead to dizziness, headache, and hypotension. Cognitive behavioral therapy generally has fewer side effects but can sometimes cause temporary increases in distress or anxiety as patients confront traumatic memories. Aerobic exercise, which is being studied for its potential benefits in PTSD, typically has side effects like muscle soreness, fatigue, and, in rare cases, injury if not performed correctly.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Post-Traumatic Stress Disorder (PTSD), primarily focusing on selective serotonin reuptake inhibitors (SSRIs) such as sertraline and paroxetine. These medications help manage symptoms by altering neurotransmitter levels in the brain. While aerobic exercise is not an FDA-approved treatment for PTSD, it is being studied for its potential benefits in enhancing neuroplasticity and cognitive function, which could complement existing pharmacological treatments. Other non-pharmacological treatments, such as cognitive-behavioral therapy (CBT), are also widely recommended for PTSD management.

What other types of research exist?

Promising novel alternatives to aerobic exercise for enhancing neuroplasticity and cognitive function in PTSD patients include: 1) Virtual Reality (VR) Therapy, which has shown efficacy in improving balance and mobility in TBI patients and may offer similar benefits for PTSD; 2) Transcranial Magnetic Stimulation (TMS), which has been explored for its potential in treating various neurological conditions, including PTSD; 3) Mind-Body Therapies such as yoga and Qigong, which have demonstrated improvements in psychological and behavioral outcomes in related conditions; and 4) Neurofeedback, which has been studied for its effects on brain function and symptom reduction in neurodevelopmental and psychiatric disorders.

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Behavioral Intervention

Exercise Therapy for PTSD

N/A

Recruiting

Led By Thomas G Adams Jr, PhD

Research Sponsored by Thomas Adams

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours (visit 2), 48 hours (visit 3)

Awards & highlights

Study Summary

This trial will investigate whether a brief bout of aerobic exercise can improve therapeutic learning in victims of interpersonal violence, with or without PTSD.

Who is the study for?

This trial is for individuals who have experienced interpersonal violence and are medically healthy. They must speak English and can have PTSD from physical or sexual assault. People with developmental disorders, active substance use (especially daily cannabis), severe obesity, psychotic disorders, certain medical conditions related to exercise, pregnancy, cardiac disease, inability to consent, major disabilities or medical disorders like cancer or AIDS cannot join.Check my eligibility

What is being tested?

The study is testing if a short session of aerobic exercise can help victims of interpersonal violence improve therapeutic learning. This could apply to those with or without PTSD. The interventions include an experimental group doing the exercise before therapy and an active control group that does not.See study design

What are the potential side effects?

Since this trial involves aerobic exercise as an intervention rather than medication, side effects may include typical responses to physical activity such as muscle soreness, fatigue or shortness of breath but should be minimal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours (visit 2), 48 hours (visit 3)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours (visit 2), 48 hours (visit 3)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours (visit 2), 48 hours (visit 3) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in participant electrodermal response

Change in participant heart rate

Change in participant subjective emotional ratings

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Moderate Intensity ExerciseExperimental Treatment1 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 eight trials of imaginal exposure (blocks of four neutral and four trauma narrative trials presented as text and sound) with heart rate monitoring and skin conductance. Anxiety will be measured at baseline and after each imagery trial. Participants will then complete 30 minutes of moderate intensity (70-75% maximum heart rate) exercise on a treadmill. Visit 3: Participants will complete eight more imaginal trials with heart rate and anxiety ratings as per visit 2.

Group II: Control - Low Intensity ExerciseActive Control1 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 eight trials of imaginal exposure (blocks of four neutral and four trauma narrative trials presented as text and sound) with heart rate monitoring and skin conductance. Anxiety will be measured at baseline and after each imagery trial. Participants will then complete 30 minutes of light intensity (40-50% maximum heart rate) exercise on a treadmill. Visit 3: Participants will complete eight more imaginal trials with heart rate and anxiety ratings as per visit 2.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Experimental

2008

Completed Phase 2

~2200

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Post-Traumatic Stress Disorder (PTSD) include psychotherapy, medications, and aerobic exercise. Psychotherapy, particularly trauma-focused cognitive-behavioral therapy (CBT), helps patients process traumatic memories and reduce symptoms through structured sessions that address thought patterns and behaviors. Medications, such as selective serotonin reuptake inhibitors (SSRIs), work by balancing neurotransmitters in the brain to alleviate mood and anxiety symptoms. Aerobic exercise, which is being studied for its potential benefits in PTSD, enhances neuroplasticity and cognitive function by increasing brain-derived neurotrophic factor (BDNF) levels and improving overall brain health. This is crucial for PTSD patients as it can help reduce threat expectations and improve the efficacy of exposure-based therapies, leading to better management of PTSD symptoms.

Aerobic exercise and consolidation of fear extinction learning among women with posttraumatic stress disorder.

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Who is running the clinical trial?

Thomas AdamsLead Sponsor

3 Previous Clinical Trials

167 Total Patients Enrolled

Thomas G Adams Jr, PhDPrincipal InvestigatorUniversity of Kentucky

1 Previous Clinical Trials

Media Library

Active Control (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05177458 — N/A

Post-Traumatic Stress Disorder Research Study Groups: Control - Low Intensity Exercise, Moderate Intensity Exercise

Post-Traumatic Stress Disorder Clinical Trial 2023: Active Control Highlights & Side Effects. Trial Name: NCT05177458 — N/A

Active Control (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05177458 — N/A

~1 spots leftby Aug 2024

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