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Purpose

The proposed project seeks to demonstrate that a brief bout of aerobic exercise can improve a particular type of therapeutic learning among women with Posttraumatic Stress Disorder (PTSD).

Condition

Eligibility

Eligible Ages
Between 21 Years and 50 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Current diagnosis of PTSD where the index traumatic event includes physical or sexual assault - English speaking - Medically healthy

Exclusion Criteria

  • Any endorsed medical concerns related to physical activity (as probed in the phone screening questions regarding cardiovascular, pulmonary, or metabolic disease and as assessed via the Physical Activity Readiness Questionnaire (PAR-Q), which probes into participants' history of heart conditions, chest pain, dizziness, loss of consciousness, bone/joint problems, and medication history). Participants would not be excluded if they report this condition being "controlled" or "addressed" through medication or lifestyle change, such as regular exercise. - Major medical disorders (such as cancer, AIDS) - Psychotic disorders - Intellectual disabilities - Developmental disorders - Active substance use disorders - Pregnancy or probably pregnancy - Body mass index greater than or equal to 35 - Daily cannabis use - History of any cardiac disease - Inability to provide informed consent - Physical disabilities that prohibit task performance (such as deafness or blindness) - Self-reported history of loss of consciousness (greater than 30 minutes)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Moderate Intensity Exercise
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.
  • Behavioral: Experimental
    Behavioral: Moderate Intensity Exercise The moderate-intensity aerobic exercise session will consist of walking or running at a moderate intensity (i.e., between 70-75% maximum heart rate) for 30 minutes on a treadmill.
Active Comparator
Control - Low Intensity Exercise
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.
  • Behavioral: Active Control
    Behavioral: Low Intensity Exercise Control participants will maintain light-intensity activity (i.e., walking at 40-50% of maximum heart rate) for 30 minutes.

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40505
Contact:
Thomas G Adams Jr, PhD
859-257-6841
tom.adams@uky.edu

More Details

NCT ID
NCT05177458
Status
Recruiting
Sponsor
Thomas Adams

Study Contact

Thomas G Adams Jr, PhD
859-257-6841
tom.adams@uky.edu

Detailed Description

The proposed study has two aims: Specific Aim 1: To examine the effects of acute exercise on the consolidation of therapeutic safety learning. It is hypothesized that participants who engage in 30-min of moderate-intensity aerobic exercise following the first session of imaginal exposure will show larger between-session (visit 2 to 3) reductions in heart rate and anxiety during imaginal exposure to trauma narratives compared to participants who engage in light-intensity exercise.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.