[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06144203":3,"trial-entities:NCT06144203":109,"trial-summary:NCT06144203":113},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":36,"secondary_outcomes":47,"sex":48,"minimum_age":49,"maximum_age":50,"healthy_volunteers":51,"eligibility_criteria":52,"std_ages":85,"locations":87,"central_contacts":103,"overall_officials":106,"references":107,"see_also_links":108},"NCT06144203","K01MH132545","The Influence of Aerobic Exercise on Consolidation of Fear Extinction Learning in PTSD","RECRUITING","2029-03","2024-02","2024-02-15","2024-01-29","University of Alabama, Tuscaloosa","OTHER",false,"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.",null,[18],"PTSD",[],"INTERVENTIONAL","BASIC_SCIENCE",[23],"NA",{"count":25,"type":26},120,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"BEHAVIORAL","Exercise","Participants will complete either a 30-minute bout of light-, moderate-, or high-intensity aerobic exercise at one of the visits.",[33,34,35],"High-intensity aerobic exercise","Light-intensity aerobic exercise","Moderate-intensity aerobic exercise",[37,41,44],{"measure":38,"description":39,"timeFrame":40},"Skin conductance responses","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.",{"measure":42,"description":43,"timeFrame":40},"Threat expectancy ratings","Threat expectancy ratings will be collected while participants are completing the cognitive task in the MRI environment.",{"measure":45,"description":46,"timeFrame":40},"Neural activity","Neural activity will be collected while participants are completing the cognitive task in the MRI environment.",[],"ALL","18 Years","64 Years",true,{"inclusion":53,"exclusion":59,"raw_text":84},[54,55,56,57,54,55,56,58],"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\u002Fsexual assault).","interpersonal violence exposure (e.g., physical\u002Fsexual assault).",[60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,71,75,76,77,78,79,80,81,82,83],"current substance use disorder (other than alcohol, nicotine, or cannabis)","acute suicidality","history of bipolar\u002Fpsychotic 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\\\u003C70)","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","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\u002Fimplanted 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","Inclusion Criteria for PTSD:\n\n* male or female sex\n* right-handed\n* age 18-64\n* a current diagnosis of PTSD where the index event involves interpersonal violence exposure (e.g., physical\u002Fsexual assault).\n\nInclusion criteria for the trauma-exposed (without PTSD) control participants includes:\n\n* male or female sex\n* right-handed\n* age 18-64\n* interpersonal violence exposure (e.g., physical\u002Fsexual assault).\n\nExclusion Criteria for all participants:\n\n* current substance use disorder (other than alcohol, nicotine, or cannabis)\n* acute suicidality\n* history of bipolar\u002Fpsychotic disorder\n* changes to or addition of psychiatric medication in the past 4 weeks (6 weeks for fluoxetine)\n* medications that effect neurovascular properties upon which BOLD fMRI capitalizes (e.g., water pills)\n* history of neurological disorders or disease (e.g., traumatic brain injury, epilepsy, seizures)\n* loss of consciousness \\> 10 minutes\n* intellectual disabilities (IQ\\\u003C70)\n* developmental disorders\n* MRI contraindication (e.g., internal ferromagnetic objects such as electronic devices, surgical implants, shrapnel; see phone screen)\n* claustrophobia or the inability to lie still in a confined space\n* physical disabilities that prohibit task performance (e.g., blindness or deafness)\n* positive pregnancy test\n* cochlear implant\n* an implanted neurostimulator\n* physical disabilities that prohibit task performance (e.g., blindness or deafness)\n* 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)\n* having a history of chest pain during physical activity\n* having a bone, joint, cardiac, or other medical condition that a doctor has said may be worsened by physical activity\n* having asthma\n* 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)\n* Percutaneous Coronary Intervention or acute myocardial infarction in the last 6 weeks\n* unstable arrhythmias\u002Fimplanted cardiac defibrillator shocks in the last 3 months\n* any other condition that the PI believes might put the participant at risk.\n* 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",[86],"ADULT",[88],{"facility":89,"status":7,"city":90,"state":91,"zip":92,"country":93,"contacts":94,"geoPoint":100},"Wade Hall - University of Alabama","Tuscaloosa","Alabama","35487","United States",[95],{"name":96,"role":97,"phone":98,"email":99},"Kevin Crombie, PhD","CONTACT","205-348-2684","kmcrombie@ua.edu",{"lat":101,"lon":102},33.20984,-87.56917,[104],{"name":96,"role":97,"phone":105,"email":99},"2053482684",[],[],[],{"nct_id":4,"conditions":110,"biomarkers":112},[111],"Post-Traumatic Stress Disorder",[],{"nct_id":4,"found":51,"summary":114,"prompt_version":124},{"design":115,"status":116,"heading":117,"summary":118,"follow_up":119,"word_count":120,"commitments":121,"compensation":122,"drugs_mentioned":123},"This is an interventional study planning to enroll 120 participants. It is designed to see if aerobic exercise affects how people process fear.","completed","Aerobic Exercise and Fear Extinction in PTSD","This study is looking at whether aerobic exercise can help people with and without Post-Traumatic Stress Disorder (PTSD) better remember how to overcome fear. Participants will complete a 30-minute session of light, moderate, or high-intensity aerobic exercise. Researchers will measure how your body reacts to fear (skin conductance responses), your feelings about threats (threat expectancy ratings), and your brain activity (neural activity) during fear-related tasks. This will help them understand if exercise improves how well you recall overcoming fear. The study aims to enroll 120 people, aged 18 to 64, who are right-handed and have experienced interpersonal violence. This includes individuals with a current PTSD diagnosis and those who have experienced trauma but do not have PTSD. The current recruitment status is unclear.","Measurements are collected during fear conditioning, fear extinction, and extinction recall tasks, which occur over a three-day protocol.",123,"You would have an initial intake visit, followed by a three-day protocol involving fear conditioning, fear extinction with activity, and fear extinction recall tasks.","Not stated in the trial record.",[30],"v2"]