Recruiting NCT06144203
The Influence of Aerobic Exercise on Consolidation of Fear Extinction Learning in PTSD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise.
- Who it may be relevant to
- Registry conditions: PTSD. Basic parameters: 18 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.]
- Threat expectancy ratings [Time frame: Collected during fear conditioning, fear extinction, and extinction recall task.]
- Neural activity [Time frame: Collected during fear conditioning, fear extinction, and extinction recall task.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Wade Hall - University of Alabama — Tuscaloosa
Identifiers
NCT: NCT06144203 · K01MH132545