NCT06144203 · University of Alabama, Tuscaloosa
The Influence of Aerobic Exercise on Consolidation of Fear Extinction Learning in PTSD
What this study is about
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).
View original scientific description
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.
Interventions
BEHAVIORAL
Exercise
Participants will complete either a 30-minute bout of light-, moderate-, or high-intensity aerobic exercise at one of the visits.
Primary outcome measures
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.
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- male or female sex
- right-handed
- 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
- 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
Where
- Tuscaloosa, Alabama
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 15, 2024 · Source of record for eligibility and locations