Recruiting

Exercise

Sponsor:

Christal L Badour

Code:

NCT06127342

Conditions

PTSD

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

Moderate Intensity Exercise

Low Intensity Exercise

Study Details

Brief summary:

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.

Conditions

PTSD

Study ID

NCT06127342

Start date

May 13, 2024

Status verified date

Aug, 2025

Completion date

Nov 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults with PTSD related to interpersonal violence

Exclusion Criteria:

  • Active or recent (within the last 3 months) severe substance use disorder(s)
  • Active or recent (within the last 3 months) suicidal, psychotic, or manic symptoms/ episodes
  • Significant developmental disabilities
  • Current daily benzodiazepine or stimulant use with inability to abstain for study sessions
  • Recent changes in psychiatric medication or trauma focused cognitive-behavioral therapy (CBT) (past 4-weeks)
  • Medical condition(s) that prohibit exercise
  • History of traumatic brain injury (TBI) with loss of consciousness > 30 mins
  • Magnetic resonance imaging (MRI) contraindication(s)
  • Positive pregnancy test
  • History of seizure disorder
  • Spontaneous seizure(s) within the last 3 months

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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 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.

active comparator: 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 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 (controlÍž 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.

Interventions

Moderate Intensity Exercise

Participants will wear a heartrate monitor and cycle on a stationary bike at a slow speed for 5 minutes, then slowly cycle on a stationary bike for 30 minutes, then cycle on the stationary bike at a slow speed for 5 minutes.

Low Intensity Exercise

Participants will wear a heartrate monitor and cycle on a stationary bike at a slow speed for 40 minutes.

Primary outcome measure

  • Change in participant subjective emotional ratings [ Time Frame: 24 hours ]
  • Change in Heart Rate [ Time Frame: 24 hours ]
  • Change in Fear Circuit Blood Oxygen Level-Dependent (BOLD) Response [ Time Frame: 48 hours ]

Central Contacts and Locations

Central contacts

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40506

Contacts

Thomas G Adams, PhD

tom.adams@uky.edu

University of Texas

Recruiting

Austin, Texas, United States, 78712

Contacts

More Information

Sponsor

Christal L Badour

Last update posted

Sep 3, 2025

Last verified

Aug, 2025

Keywords

  • Interpersonal Violence
  • Exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Christal L Badour on 2025-09-03.