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NCT Number: NCT06144203

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

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wade Hall - University of Alabama

Tuscaloosa, Alabama, 35487, United States

Location status: Recruiting

Location contact

Kevin Crombie, PhD

CONTACT

[email protected]

205-348-2684

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for PTSD:

  • 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

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

Treatment and study plan

Exercise

Behavioral

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

Primary outcomes

  1. Skin conductance responses

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

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

  2. Threat expectancy ratings

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

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

  3. Neural activity

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Kevin Crombie, PhD

CONTACT

[email protected]

2053482684

Sponsors and collaborators

Lead sponsor

University of Alabama, Tuscaloosa

Other

Registry information

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Nov 22, 2023
Registry last updated
Feb 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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