- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06144203
The Influence of Aerobic Exercise on Consolidation of Fear Extinction Learning in PTSD
February 13, 2024 updated by: Kevin Crombie, University of Alabama, Tuscaloosa
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.
Study Overview
Study Type
Interventional
Enrollment (Estimated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kevin Crombie, PhD
- Phone Number: 2053482684
- Email: kmcrombie@ua.edu
Study Locations
-
-
Alabama
-
Tuscaloosa, Alabama, United States, 35487
- Recruiting
- Wade Hall - University of Alabama
-
Contact:
- Kevin Crombie, PhD
- Phone Number: 205-348-2684
- Email: kmcrombie@ua.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Light-intensity aerobic 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
|
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
|
Participants will complete either a 30-minute bout of light-, moderate-, or high-intensity aerobic exercise at one of the visits.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Collected during fear conditioning, fear extinction, and extinction recall task.
|
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.
|
Collected during fear conditioning, fear extinction, and extinction recall task.
|
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.
|
Collected during fear conditioning, fear extinction, and extinction recall task.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 29, 2024
Primary Completion (Estimated)
March 1, 2029
Study Completion (Estimated)
March 1, 2029
Study Registration Dates
First Submitted
November 16, 2023
First Submitted That Met QC Criteria
November 16, 2023
First Posted (Actual)
November 22, 2023
Study Record Updates
Last Update Posted (Estimated)
February 15, 2024
Last Update Submitted That Met QC Criteria
February 13, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- K01MH132545 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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