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

Sponsor
University of Alabama, Tuscaloosa (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06144203
Collaborator
(none)
120
3
63

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Exercise
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
The Influence of Aerobic Exercise on Consolidation of Fear Extinction Learning in PTSD
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2029
Anticipated Study Completion Date :
Mar 1, 2029

Arms and Interventions

Arm Intervention/Treatment
Experimental: Light-intensity aerobic exercise

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

Experimental: Moderate-intensity aerobic exercise

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

Experimental: High-intensity aerobic exercise

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

Outcome Measures

Primary Outcome Measures

  1. Skin conductance responses [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Alabama, Tuscaloosa

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kevin Crombie, Assistant Professor, University of Alabama, Tuscaloosa
ClinicalTrials.gov Identifier:
NCT06144203
Other Study ID Numbers:
  • K01MH132545
First Posted:
Nov 22, 2023
Last Update Posted:
Nov 24, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 24, 2023