PTSDNCT06144203
The Influence of Aerobic Exercise on Consolidation of Fear Extinction Learning in PTSD
A study testing Exercise in people with PTSD, run by University of Alabama, Tuscaloosa at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- PTSD
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2024to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- right-handed
- age 18-64
- interpersonal violence exposure (e.g., physical/sexual assault).
Who cannot join
- 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)
Show all 25Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wade Hall - University of Alabama
Tuscaloosa, Alabama, 35487
Kevin Crombie, PhD, 205-348-2684, kmcrombie@ua.edu
About this study
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.
- Conditions
- PTSD
- Being tested
- Exercise
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Participants will complete either a 30-minute bout of light-, moderate-, or high-intensity aerobic exercise at one of the visits.
| Study group | Role | What they receive |
|---|---|---|
| Light-intensity aerobic exercise | Experimental | Not described Receives: Behavioral: Exercise |
| Moderate-intensity aerobic exercise | Experimental | Not described Receives: Behavioral: Exercise |
| High-intensity aerobic exercise | Experimental | Not described Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin conductance responses
SCR data will be collected while participants are completing the cognitive task in the MRI environment.
Measured: Collected during fear conditioning, fear extinction, and extinction recall task.
Threat expectancy ratings
Threat expectancy ratings will be collected while participants are completing the cognitive task in the MRI environment.
Measured: Collected during fear conditioning, fear extinction, and extinction recall task.
Neural activity
Neural activity will be collected while participants are completing the cognitive task in the MRI environment.
Measured: Collected during fear conditioning, fear extinction, and extinction recall task.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start29 Jan 2024
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama, Tuscaloosa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Crombie, University of Alabama, Tuscaloosa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144203
- Sponsor's protocol ID
- K01MH132545
- Status last verified
- Feb 2024
- First submitted
- 16 Nov 2023
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Aerobic Exercise on Consolidation of Fear Extinction Learning in PTSD
- ClinicalTrials.gov ID
- NCT06144203
- Acronym / sponsor ID
- K01MH132545
- Conditions
- PTSD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Alabama, TuscaloosaUniversity, hospital or other
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Light-intensity aerobic exercise | Experimental | Behavioral: Exercise |
| Moderate-intensity aerobic exercise | Experimental | Behavioral: Exercise |
| High-intensity aerobic exercise | Experimental | Behavioral: Exercise |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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).
- male or female sex
Key exclusion criteria (25 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseParticipants will complete either a 30-minute bout of light-, moderate-, or high-intensity aerobic exercise at one of the visits. | Behavioural | High-intensity aerobic exercise, Light-intensity aerobic exercise, Moderate-intensity aerobic exercise |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
Related trials for PTSD
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with PTSD, run by University of Alabama, Tuscaloosa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kevin Crombie, PhD (2053482684, kmcrombie@ua.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin conductance responses (time frame: Collected during fear conditioning, fear extinction, and extinction recall task.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.