[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06246669":3,"trial-entities:NCT06246669":135,"trial-summary:NCT06246669":139},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":39,"secondary_outcomes":55,"sex":70,"minimum_age":71,"maximum_age":72,"healthy_volunteers":73,"eligibility_criteria":74,"std_ages":84,"locations":86,"central_contacts":105,"overall_officials":110,"references":111,"see_also_links":134},"NCT06246669","HSR230522","The Influence of Prescribed Exercise on Pain Related Fear Following Concussion in Collegiate Athletes","The Influence of Prescribed Exercise on Pain Related Fear Following Concussion in Collegiate Athletes: A Randomized Controlled Trial","RECRUITING","2025-03","2024-12","2024-12-09","2024-02-27","University of Virginia","OTHER",true,"The goal of this clinical trial is to compare the effects of acute aerobic exercise at two different intensities on psychological measures, symptomology, and time to symptom free in collegiate student athletes with concussion. The main questions it aims to answer are:\n\n* Does prescribed, acute aerobic exercise influence measures of pain related fear, anxiety, depression, symptoms, and recovery time?\n* Does the intensity of the exercise prescription also influence the aforementioned outcomes?\n\nParticipants will be randomly assigned into either a light intensity or moderate intensity aerobic exercise (treadmill walking) group. They will initiate the exercise protocol 48 hours following their concussion diagnosis, and complete exercise sessions 5 times per week until they report symptom-free. Researchers will compare the light intensity group to the moderate intensity group to see if intensity of exercise influences psychological measures of pain related fear, anxiety, depression, symptomology, and time to symptom-free.",null,[19],"Concussion, Brain",[21,22,23],"kinesiophobia","exercise","anxiety","INTERVENTIONAL","TREATMENT",[27],"NA",{"count":29,"type":30},46,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"BEHAVIORAL","Treadmill Walking","A treadmill will be used for participant to walk on. The frequency of exercise will be 5 times per week until they report symptom-free. The intensity will be determined via random group allocation (RPE of 13 or 9). The type of exercise is treadmill walking. The time of the intervention will depend on the the time it takes an individual to reach a specific caloric expenditure as a function of their weight and treadmill incline. This is based on the most recent American Congress of Sports Medicine's guidelines for estimating gross energy expenditure during common physical activities.",[37,38],"Light Intensity","Moderate Intensity",[40,44,47,51],{"measure":41,"description":42,"timeFrame":43},"The Tampa Scale of Kinesiophobia-17 (TSK-17)","A measure of fear beliefs associated with exercise, movement, and re-injury. Minimum score of 17, Maximum 68. Higher scores indicate worse kinesiophobia.","48 hours after concussion diagnosis and then every other day until participant reports symptom free which takes, on median, 6 days with a range of 0-203 days at the research site.",{"measure":45,"description":46,"timeFrame":43},"Athlete Fear Avoidance Questionnaire (AFAQ)","A measure of fear avoidance specifically designed for injured athletes. Minimum score of 10, Maximum score of 50. Higher scores indicate higher levels of fear-avoidance.",{"measure":48,"description":49,"timeFrame":50},"Revised Head Injury Scale (HIS-r)","A measure of 22 concussion related symptoms and their associated duration and severity over the previous 24 hours. Minimum duration of 1 and a maximum duration of 132. Minimum severity of 0 and maximum severity of 132. Higher levels of symptom count, duration, and severity indicate worse symptomology.","48 hours after concussion diagnosis and then every single day until participant reports symptom free which takes, on median, 6 days with a range of 0-203 days at the research site.",{"measure":52,"description":53,"timeFrame":54},"Days until symptom-free","The time it takes, in days, for a participant to report symptom free.","Depends on individual injury characteristics but has a median of 6 days, range of 0-203 days at the research site.",[56,59,62,66],{"measure":57,"description":58,"timeFrame":43},"Generalized Anxiety Index-7 (GAD-7)","Measure of anxiety levels over previous two weeks. Minimum score of 0 and maximum score of 21. Higher scores indicating higher levels of anxiety.",{"measure":60,"description":61,"timeFrame":43},"Patient Health Questionnaire-9 (PHQ-9)","Measure of depression levels over previous two weeks. Minimum score of 0 and maximum score of 27. Higher scores indicate higher levels of depression.",{"measure":63,"description":64,"timeFrame":65},"Days until return to sport","The time it takes, in days, for a participant to make a full return to their sport.","Depends on individual injury characteristics but will be, on median, 5 days after reporting symptom free which takes 6 days on median at the research site.",{"measure":67,"description":68,"timeFrame":69},"Step count","Number of steps taken during daily life outside of intervention.","Step count recording will begin 48 hours after concussion diagnosis and then every single day until participant reports symptom free which takes, on median, 6 days with a range of 0-203 days at the research site.","ALL","18 Years","25 Years",false,{"inclusion":75,"exclusion":78,"raw_text":83},[76,77],"Collegiate athlete (varsity)","Symptomatic at time of exercise prescription",[79,80,81,82],"If advanced neuroimaging was performed, any subject with a structural abnormality will be excluded","History of traumatic brain injury requiring hospitalization","Not cleared to play their sport by a physician due to some other injury such as an ankle sprain or muscle strain","If individual is diagnosed with any condition that is a contraindication to aerobic exercise. Please note that all participants will have already been cleared to participate in their respective collegiate sport after extensive pre-participation physical examinations upon entering the university.","Inclusion Criteria:\n\n* Collegiate athlete (varsity)\n* Symptomatic at time of exercise prescription\n\nExclusion Criteria:\n\n* If advanced neuroimaging was performed, any subject with a structural abnormality will be excluded\n* History of traumatic brain injury requiring hospitalization\n* Not cleared to play their sport by a physician due to some other injury such as an ankle sprain or muscle strain\n* If individual is diagnosed with any condition that is a contraindication to aerobic exercise. Please note that all participants will have already been cleared to participate in their respective collegiate sport after extensive pre-participation physical examinations upon entering the university.",[85],"ADULT",[87],{"facility":88,"status":8,"city":89,"state":90,"zip":91,"country":92,"contacts":93,"geoPoint":102},"University of Virginia Department of Kinesiology","Charlottesville","Virginia","22903","United States",[94,99],{"name":95,"role":96,"phone":97,"email":98},"Jake Resch, PhD","CONTACT","434-243-6525","jer6x@virginia.edu",{"name":100,"role":96,"email":101},"Daniel Rosenblum, M.Ed.","dr6gz@virginia.edu",{"lat":103,"lon":104},38.02931,-78.47668,[106,108],{"name":95,"role":96,"phone":107,"email":98},"434-243-6535",{"name":100,"role":96,"phone":109,"email":101},"203-253-4887",[],[112,116,119,122,125,128,131],{"pmid":113,"type":114,"citation":115},"37316185","BACKGROUND","Leddy JJ, Burma JS, Toomey CM, Hayden A, Davis GA, Babl FE, Gagnon I, Giza CC, Kurowski BG, Silverberg ND, Willer B, Ronksley PE, Schneider KJ. Rest and exercise early after sport-related concussion: a systematic review and meta-analysis. Br J Sports Med. 2023 Jun;57(12):762-770. doi: 10.1136\u002Fbjsports-2022-106676.",{"pmid":117,"type":114,"citation":118},"28570092","Lal A, Kolakowsky-Hayner SA, Ghajar J, Balamane M. The Effect of Physical Exercise After a Concussion: A Systematic Review and Meta-analysis. Am J Sports Med. 2018 Mar;46(3):743-752. doi: 10.1177\u002F0363546517706137. Epub 2017 Jun 1.",{"pmid":120,"type":114,"citation":121},"29668716","Lawrence DW, Richards D, Comper P, Hutchison MG. Earlier time to aerobic exercise is associated with faster recovery following acute sport concussion. PLoS One. 2018 Apr 18;13(4):e0196062. doi: 10.1371\u002Fjournal.pone.0196062. eCollection 2018.",{"pmid":123,"type":114,"citation":124},"36049743","Thompson XD, Newman TM, Donahue CC, Erdman NK, Statuta SM, Resch JE. Kinesiophobia Is Related to Acute Musculoskeletal Injury Incidence Following Concussion. J Sport Rehabil. 2022 Sep 1;32(2):145-150. doi: 10.1123\u002Fjsr.2022-0134. Print 2023 Feb 1.",{"pmid":126,"type":114,"citation":127},"34404602","Reinking S, Seehusen CN, Walker GA, Wilson JC, Howell DR. Transitory kinesiophobia after sport-related concussion and its correlation with reaction time. J Sci Med Sport. 2022 Jan;25(1):20-24. doi: 10.1016\u002Fj.jsams.2021.07.010. Epub 2021 Jul 29.",{"pmid":129,"type":114,"citation":130},"35589367","Jadhakhan F, Sobeih R, Falla D. Effects of exercise\u002Fphysical activity on fear of movement in people with spine-related pain: protocol for a systematic review and meta-analysis. BMJ Open. 2022 May 19;12(5):e060264. doi: 10.1136\u002Fbmjopen-2021-060264.",{"pmid":132,"type":114,"citation":133},"37316210","Patricios JS, Schneider KJ, Dvorak J, Ahmed OH, Blauwet C, Cantu RC, Davis GA, Echemendia RJ, Makdissi M, McNamee M, Broglio S, Emery CA, Feddermann-Demont N, Fuller GW, Giza CC, Guskiewicz KM, Hainline B, Iverson GL, Kutcher JS, Leddy JJ, Maddocks D, Manley G, McCrea M, Purcell LK, Putukian M, Sato H, Tuominen MP, Turner M, Yeates KO, Herring SA, Meeuwisse W. Consensus statement on concussion in sport: the 6th International Conference on Concussion in Sport-Amsterdam, October 2022. Br J Sports Med. 2023 Jun;57(11):695-711. doi: 10.1136\u002Fbjsports-2023-106898.",[],{"nct_id":4,"conditions":136,"biomarkers":138},[137],"Concussion",[],{"nct_id":4,"found":15,"summary":140,"prompt_version":150},{"design":141,"status":142,"heading":143,"summary":144,"follow_up":145,"word_count":146,"commitments":147,"compensation":148,"drugs_mentioned":149},"This is an interventional study planning to enroll 46 collegiate athletes. Participants will be randomly assigned to one of two groups: light intensity or moderate intensity treadmill walking.","completed","Exercise for Concussion Recovery in Collegiate Athletes","This study is looking at how different intensities of treadmill walking can help collegiate athletes recover from a concussion. Researchers want to see if prescribed exercise, specifically treadmill walking, can reduce pain-related fear and other symptoms, and how quickly athletes become symptom-free. You might be able to join if you are a collegiate athlete between 18 and 25 years old, have recently had a concussion, and are currently experiencing symptoms. You would be randomly assigned to either a light or moderate intensity treadmill walking group. The study aims to understand if exercise, and its intensity, can improve recovery after a concussion.","You will be followed until you report being symptom-free, which can range from 0 to 203 days.",101,"You would start treadmill walking 48 hours after your concussion diagnosis, exercising 5 times per week until you report being symptom-free. You will also complete questionnaires about your symptoms and fear every other day until you are symptom-free.","Not stated in the trial record.",[34],"v2"]