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RecruitingNCT06144203Updated Feb 15, 2024

The Influence of Aerobic Exercise on Consolidation of Fear Extinction Learning in PTSD

An interventional study of Exercise in PTSD, sponsored by University of Alabama, Tuscaloosa. Recruiting at 1 site in United States. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-15.

Sponsored by University of Alabama, Tuscaloosa · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Jan 2024; still recruiting 2 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study summary

This study aims to test whether aerobic exercise performed after fear extinction learning improves cognitive, physiological, and neural indices of extinction recall in a sample of trauma-exposed men and women with and without posttraumatic stress disorder (PTSD). Participants will complete a clinical intake visit (Day 0), followed by a three-day fear conditioning (day 1), fear extinction + activity (day 2), and fear extinction recall (day 3) protocol.

02

Conditions studied

  • PTSD
03

In context

Lead sponsor

University of Alabama, Tuscaloosa is the lead sponsor of 39 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • male or female sex
  • right-handed
  • age 18-64
  • a current diagnosis of PTSD where the index event involves interpersonal violence exposure (e.g., physical/sexual assault).

Inclusion criteria for the trauma-exposed (without PTSD) control participants includes:

  • male or female sex
  • right-handed
  • age 18-64
  • interpersonal violence exposure (e.g., physical/sexual assault).

Exclusion criteria

Exclusion Criteria for all participants:

  • current substance use disorder (other than alcohol, nicotine, or cannabis)
  • acute suicidality
  • history of bipolar/psychotic disorder
  • changes to or addition of psychiatric medication in the past 4 weeks (6 weeks for fluoxetine)
  • medications that effect neurovascular properties upon which BOLD fMRI capitalizes (e.g., water pills)
  • history of neurological disorders or disease (e.g., traumatic brain injury, epilepsy, seizures)
  • loss of consciousness > 10 minutes
  • intellectual disabilities (IQ\<70)
  • developmental disorders
  • MRI contraindication (e.g., internal ferromagnetic objects such as electronic devices, surgical implants, shrapnel; see phone screen)
  • claustrophobia or the inability to lie still in a confined space
  • physical disabilities that prohibit task performance (e.g., blindness or deafness)
  • positive pregnancy test
  • cochlear implant
  • an implanted neurostimulator
  • physical disabilities that prohibit task performance (e.g., blindness or deafness)
  • vulnerable populations (i.e., pregnant women, individuals appearing to lack consent capacity, prisoners, individuals unable to read consent materials, individuals in a relationship with study researchers (e.g., friends, family members, significant others)
  • having a history of chest pain during physical activity
  • having a bone, joint, cardiac, or other medical condition that a doctor has said may be worsened by physical activity
  • having asthma
  • responding 'Yes' to any of the seven questions on the Physical Activity Readiness Questionnaire (PAR-Q - administered as part of the Exercise Safety Questions of the phone screen), indicating it is unsafe for the individual to engage in aerobic exercise without physician approval (i.e., potential participant would be eligible to participate if they indicated 'Yes' to one or more of the PAR-Q items provided they obtain a doctor's note indicating it is safe for them to participate in the study)
  • Percutaneous Coronary Intervention or acute myocardial infarction in the last 6 weeks
  • unstable arrhythmias/implanted cardiac defibrillator shocks in the last 3 months
  • any other condition that the PI believes might put the participant at risk.
  • Additionally, due to their effects on image quality, interested individuals with the following may be ineligible to participate per PI's judgement: nonremovable dental implants (e.g., braces or upper permanent retainers) as these will distort the MRI images we collect (note: filings, crowns, and silver or gold teeth are okay); any other condition, medication, or implant that the PI believes would degrade image quality or render data unusable
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Light-intensity aerobic exercise

    Behavioral: Exercise

  • Experimental
    Moderate-intensity aerobic exercise

    Behavioral: Exercise

  • Experimental
    High-intensity aerobic exercise

    Behavioral: Exercise

Interventions

  • BehavioralExercise

    Participants will complete either a 30-minute bout of light-, moderate-, or high-intensity aerobic exercise at one of the visits.

06

What researchers measure

Primary outcomes

  1. Skin conductance responses

    SCR data will be collected while participants are completing the cognitive task in the MRI environment.

    Time frame: Collected during fear conditioning, fear extinction, and extinction recall task.

  2. Threat expectancy ratings

    Threat expectancy ratings will be collected while participants are completing the cognitive task in the MRI environment.

    Time frame: Collected during fear conditioning, fear extinction, and extinction recall task.

  3. Neural activity

    Neural activity will be collected while participants are completing the cognitive task in the MRI environment.

    Time frame: Collected during fear conditioning, fear extinction, and extinction recall task.

07

Study locations

1 of 1 sites recruiting
  • Wade Hall - University of Alabama
    Tuscaloosa, Alabama 35487, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06144203
Lead sponsor
University of Alabama, Tuscaloosa
Responsible party
Kevin Crombie (Assistant Professor, University of Alabama, Tuscaloosa) — Principal investigator
First posted
Nov 22, 2023
Start date
Jan 29, 2024
Primary completion
Mar 2029 (estimated)
Completion
Mar 2029 (estimated)
Last update
Feb 15, 2024

Study contacts

Kevin Crombie, PhD
Contact
kmcrombie@ua.edu
2053482684

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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