[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07733284":3,"trial-entities:NCT07733284":105,"trial-summary:NCT07733284":109},{"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":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":39,"secondary_outcomes":50,"sex":61,"minimum_age":62,"maximum_age":63,"healthy_volunteers":15,"eligibility_criteria":64,"std_ages":82,"locations":85,"central_contacts":100,"overall_officials":102,"references":103,"see_also_links":104},"NCT07733284","E-1314-26","Home-Based Walking for Thinking Skills in Persons With TBI","Safety and Feasibility of Remote Walking Exercise for Cognitive Improvement in Persons With TBI","RECRUITING","2026-12","2026-07","2026-07-29","2026-04-15","Kessler Foundation","OTHER",false,"The purpose of this research study is to investigate the effects of a home-based 3-month long walking exercise program on cognitive (thinking) performance in persons with TBI. As a participant, you will complete this 3-month exercise program now or after a 3-month wait period.","This study involves no in-person visits to Kessler Foundation and takes place at home.\n\nThe first study activity will last about 1 hour in total and will involve using videoconferencing software (Zoom) to take tests of thinking (e.g., matching shapes and number, learning a list of words). You will then complete several brief questionnaires about everyday activities and TBI symptoms over the computer.\n\nYou will then be randomly picked (like the flip of a coin) by a computer to participate in one of two groups. You will have a 50\u002F50 chance of being placed in either group.\n\nOne group will complete 3-months of walking exercise at home. The exercise program is based on activity guidelines for people with TBI and will be monitored by a trained exercise leader. You will be asked to walk 3 times per week. The first two weeks will require you to walk for 10 minutes at a time, and that duration will increase throughout the 3-months. You will have a dedicated trainer to help get started, answer questions, and support you throughout the programs. You will have regular meetings with this trainer by video conference (Zoom). You will be sent a FitBit to wear on your wrist while exercising to track your steps, and that you will be allowed to keep when the study ends.\n\nThe other group will stick to a regular routine during this 3-month period (i.e., wait-list group).\n\nAt the end of the 3-month exercise program, you will repeat the thinking tests and questionnaires. The wait-list group will be given the exercise prescription after this last Zoom session.",[19],"Traumatic Brain Injury (TBI) Patients",[21,22,23,24],"walking","thinking","fitbit","exercise","INTERVENTIONAL","TREATMENT",[28],"EARLY_PHASE1",{"count":30,"type":31},40,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37},"BEHAVIORAL","Walking","One group will complete 3-months of walking exercise at home. The exercise program is based on activity guidelines for people with TBI and will be monitored by a trained exercise leader. You will be asked to walk 3 times per week. The first two weeks will require you to walk for 10 minutes at a time, and that duration will increase throughout the 3-months. You will have a dedicated trainer to help get started, answer questions, and support you throughout the programs. You will have regular meetings with this trainer by video conference (Zoom). You will be sent a FitBit to wear on your wrist while exercising to track your steps, and that you will be allowed to keep when the study ends.",[38],"Behavioral: Exercise",[40,44,47],{"measure":41,"description":42,"timeFrame":43},"Adverse Events","Safety will be primarily measured as adverse events, specifically during the remote walking intervention.","Through study completion, which is 3 months for intervention and 6 months for wait list.",{"measure":45,"description":46,"timeFrame":43},"Adherence","Adherence is measured as the number of exercise sessions attended compared to the number of total sessions prescribed.",{"measure":48,"description":49,"timeFrame":43},"Compliance","Compliance will be measured as the number of exercise sessions completed as prescribed (i.e., intensity and duration).",[51,55,58],{"measure":52,"description":53,"timeFrame":54},"Processing Speed","Neuropsychological assessments will be administered to measure processing speed using the symbol digit modalities test (SDMT).","Baseline and follow-up (12-weeks post-baseline)",{"measure":56,"description":57,"timeFrame":54},"Learning\u002FMemory","Neuropsychological assessments will be administered to measure processing learning and memory using the California Verbal Learning Test (CVLT).",{"measure":59,"description":60,"timeFrame":54},"Executive function","Neuropsychological assessments will be administered to measure executive function using the Delis-Kaplan Executive Function System (DKEFS).","ALL","18 Years","65 Years",{"inclusion":65,"exclusion":75,"raw_text":81},[66,67,68,69,70,71,72,73,74],"Definitive TBI diagnosis at least 1 year prior, verified by medical records","Self-report problems with thinking skills since the TBI diagnosis (e.g., processing information, learning or remembering, organizing, multitasking)","Between the ages of 18 and 65","Access to internet and email","Fluent in English","Can walk at a brisk pace without using an assistive device","Not fallen due to mobility issues from their TBI in the past 6 months","Do not currently meet public health guidelines for physical activity","Have problems with thinking performance",[76,77,78,79,80],"I currently have uncontrolled major depression","I have a history of schizophrenia, bipolar disorder I or II, or substance-abuse disorders","I am regularly taking medications that can affect my thinking, such as antipsychotics or benzodiazepines. Study staff will review my medications to determine if I am taking any that would make me ineligible for this study","I have known\u002Fdiagnosed cardiovascular disease including uncontrolled hypertension, diabetes, or kidney disease","I am unable to make everyday decisions on my own","Inclusion Criteria:\n\n* Definitive TBI diagnosis at least 1 year prior, verified by medical records\n* Self-report problems with thinking skills since the TBI diagnosis (e.g., processing information, learning or remembering, organizing, multitasking)\n* Between the ages of 18 and 65\n* Access to internet and email\n* Fluent in English\n* Can walk at a brisk pace without using an assistive device\n* Not fallen due to mobility issues from their TBI in the past 6 months\n* Do not currently meet public health guidelines for physical activity\n* Have problems with thinking performance\n\nExclusion Criteria:\n\n* I currently have uncontrolled major depression\n* I have a history of schizophrenia, bipolar disorder I or II, or substance-abuse disorders\n* I am regularly taking medications that can affect my thinking, such as antipsychotics or benzodiazepines. Study staff will review my medications to determine if I am taking any that would make me ineligible for this study\n* I have known\u002Fdiagnosed cardiovascular disease including uncontrolled hypertension, diabetes, or kidney disease\n* I am unable to make everyday decisions on my own",[83,84],"ADULT","OLDER_ADULT",[86],{"facility":13,"status":8,"city":87,"state":88,"zip":89,"country":90,"contacts":91,"geoPoint":97},"East Hanover","New Jersey","07936","United States",[92],{"name":93,"role":94,"phone":95,"email":96},"Carly Wender, PhD","CONTACT","973-324-8388","cwender@kesslerfoundation.org",{"lat":98,"lon":99},40.8201,-74.36487,[101],{"name":93,"role":94,"phone":95,"email":96},[],[],[],{"nct_id":4,"conditions":106,"biomarkers":108},[107],"Traumatic Encephalopathy",[],{"nct_id":4,"found":110,"summary":111,"prompt_version":120},true,{"design":112,"status":113,"heading":6,"summary":114,"follow_up":115,"word_count":116,"commitments":117,"compensation":118,"drugs_mentioned":119},"This is an interventional study with 40 planned participants. You will be randomly assigned to one of two groups, like flipping a coin, with a 50\u002F50 chance of being in either group.","completed","This study is looking at whether a 3-month home-based walking program can help improve thinking skills in people who have had a traumatic brain injury (TBI). You can join if you are 18-65 years old, have a TBI diagnosis from at least one year ago, and experience problems with thinking skills like remembering or organizing. You also need internet access and to be able to walk at a brisk pace without help. The study aims to see if participants stick to the walking program and if there are any side effects. You will either start the walking program right away or after a 3-month waiting period. The study is currently unclear on its recruitment status and plans to enroll 40 participants.","Participants in the intervention group will be followed for 3 months, and those in the wait-list group for 6 months.",121,"You will complete an initial 1-hour video call for thinking tests and questionnaires. If in the walking group, you will walk 3 times per week for 3 months, starting with 10 minutes and increasing over time. You will have regular video meetings with a trainer.","Not stated in the trial record.",[35],"v2"]