[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06799429":3,"trial-entities:NCT06799429":131,"trial-summary:NCT06799429":135},{"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":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":41,"secondary_outcomes":68,"sex":78,"minimum_age":79,"maximum_age":80,"healthy_volunteers":14,"eligibility_criteria":81,"std_ages":91,"locations":94,"central_contacts":121,"overall_officials":128,"references":129,"see_also_links":130},"NCT06799429","Pro00139826","Train Your Brain Fitness SC: An Exercise Intervention for People With Cognitive Impairments","RECRUITING","2026-11-17","2026-04","2026-06-01","2026-03-13","University of South Carolina","OTHER",false,"The goal of this clinical trial is to test a twice a week, moderate intensity exercise and coaching program (an in-person group and a distance group) for adults with mild-moderate cognitive impairments living in South Carolina. The main questions it aims to answer are:\n\n1. Is the program practical to conduct, and it is acceptable and enjoyable? The hypothesis is that it will be possible to recruit participants, obtain the desired dosage of moderate intensity fitness and strength training twice a week for both groups.\n2. Are their changes at 3, 6, 9 and 12 months in endurance, mobility, cognitive function and perception of cognitive function? The hypotheses are that endurance, strength and mobility will improve and cognitive measures will not decline (remain the same or improve) for both groups.","In person Exercise Group (Columbia, SC):\n\nThe exercise program interventions will be individualized based on exercise history, and initial assessments by the primary investigator (a physical therapist). The program will focus on building up to 30 minutes of moderate intensity endurance activity and up to 30 minutes of strength training, balance training and mobility training. Participants will attend two times per week. Study coaches will provide exercise plans, and monitor and provide feedback as participants exercise. Participants will wear a heart rate monitor to record exertion and coaches will record exercise and intensity in online coaching software.\n\nDistance Exercise Group: (Sumter, SC):\n\nThe exercise program interventions will be individualized based on exercise history, and initial assessments by the primary investigator (a physical therapist) which will occur in person. The program will focus on building up to 30 minutes of moderate intensity endurance activity and up to 30 minutes of strength training, balance training and mobility training. Coaches will prescribe an exercise program that can be performed at a local fitness facility and it will be shared through a coaching software or paper log. Participants will have in-person fading facility personal trainer support for 7 visits in the first 12-weeks and complete the remaining twice weekly exercise on their own. Participants will log their exercises and intensity either in the coaching software or in paper formats, have bi-weekly check-ins with fitness center coaches and have options to message the fitness center coaches with questions.",[18],"Mild-moderate Cognitive Impairment",[20,21],"cognitive impairment","exercise","INTERVENTIONAL","SUPPORTIVE_CARE",[25],"NA",{"count":27,"type":28},50,"ESTIMATED",[30,36],{"type":31,"name":32,"description":33,"armGroupLabels":34},"BEHAVIORAL","Supervised Exercise and Behavior Modification Support","The exercise intervention will have a goal of up to minutes (60 minutes 2 x a week) of moderate intensity exercise building up to that amount based on ability. This will include 45-60 minutes per week of cardiovascular activity, 30-60 minutes of functional strength training targeting major muscle groups (to include at a minimum: a squat movement, an upper extremity push movement, an upper extremity pull movement, a carry movement, a stepping movement and a trunk stabilization movement), and 10-20 minutes of balance, agility and mobility exercises. Study coach is with the participant when they exercise and records exercise and intensity. Study coaches provide behavior modification support through goal setting, encouragement, feedback and reviewing outcomes.",[35],"In-Person Group",{"type":31,"name":37,"description":38,"armGroupLabels":39},"Monitored Exercise and Behavioral Modification Support","The exercise intervention will have a goal of up to minutes (60 minutes 2 x a week) of moderate intensity exercise building up to that amount based on ability. This will include 45-60 minutes per week of cardiovascular activity, 30-60 minutes of functional strength training targeting major muscle groups (to include at a minimum: a squat movement, an upper extremity push movement, an upper extremity pull movement, a carry movement, a stepping movement and a trunk stabilization movement), and 10-20 minutes of balance, agility and mobility exercises. Support for performing their exercise will be provided by a personal trainer at the fitness facility where they exercise for up to seven visits. The remainder of the twice weekly exercise will be completed and logged by the participant on their own. Study coaches provide behavior modification support through goal setting, encouragement, feedback and reviewing outcomes via phone, text and\u002For email.",[40],"Distance Group",[42,46,49,52,55,58,62,65],{"measure":43,"description":44,"timeFrame":45},"Aim 1 Feasibility: Recruitment and Uptake through qualified referrals","percent of qualified referrals beginning the program","through study completion, an average of 1 year",{"measure":47,"description":48,"timeFrame":45},"Aim 1 Feasibility: Program Fidelity Dosage: session adherence","mean percentage adherence (number of sessions completed \u002F number of sessions scheduled)",{"measure":50,"description":51,"timeFrame":45},"Aim 1 Feasibility: Program Fidelity Dosage: Session Duration","mean percentage duration",{"measure":53,"description":54,"timeFrame":45},"Aim 1 Feasibility: Program Fidelity: Exercise Intensity","mean percent of time spent in target heart rate zone of 60-85% of age predicted maximum",{"measure":56,"description":57,"timeFrame":45},"Aim 1 Feasibility: Acceptability: Participant Satisfaction","mean of 5 point likert scale 1-not satisfied to 5-extremely satisfied",{"measure":59,"description":60,"timeFrame":61},"Aim 2 Exploratory Individual Outcomes: Processing Speed and Executive Function through the Oral Symbol Digits Test (NIH Toolbox)","Score is number of correct responses (0-144), with higher score as better performance","pre-program (baseline), 3, 6 9 and 12 months",{"measure":63,"description":64,"timeFrame":61},"Aim 2 Exploratory Individual Outcomes: Cardiovascular Endurance through the six-minute walk test","Score is meters walked, higher is better performance",{"measure":66,"description":67,"timeFrame":61},"Aim 2 Exploratory Individual Outcomes: Working Memory through the Auditory Verbal Learning Test (NIH Toolbox)","Score is number of correct responses (0-45), with higher score as better performance",[69,72,75],{"measure":70,"description":71,"timeFrame":61},"Aim 2 Exploratory Individual Outcomes: Mobility and Balance through the Short Physical Performance Battery","Score is 0-12 with higher as better performance",{"measure":73,"description":74,"timeFrame":61},"Aim 2 Exploratory Individual Outcomes: Grip Strength using a hand-held grip dynamometer (lbs. of force)","Measured bilateral in lbs of force, higher is better performance",{"measure":76,"description":77,"timeFrame":61},"Aim 2 Exploratory Individual Outcomes: Perception of cognition through the Patient-Reported Outcomes Measurement Information System (PROMIS) Computer Adaptive Testing survey","0-100% with lower than 50% below average and higher above average performance","ALL","18 Years",null,{"inclusion":82,"exclusion":87,"raw_text":90},[83,84,85,86],"adult (age \\>18)","medical diagnosis of mild-moderate cognitive impairment","medical clearance by referring provider for exercise","able to follow 2-step commands",[88,89],"significant pain with movement (\\>5\u002F10)","severe balance impairments or lack of independence on and off exercise equipment (by physical therapist judgment at Intake)","Inclusion criteria:\n\n* adult (age \\>18)\n* medical diagnosis of mild-moderate cognitive impairment\n* medical clearance by referring provider for exercise\n* able to follow 2-step commands\n\nExclusion criteria:\n\n* significant pain with movement (\\>5\u002F10)\n* severe balance impairments or lack of independence on and off exercise equipment (by physical therapist judgment at Intake)",[92,93],"ADULT","OLDER_ADULT",[95,110],{"facility":96,"status":7,"city":97,"state":98,"zip":99,"country":100,"contacts":101,"geoPoint":107},"Arnold School of Public Health","Columbia","South Carolina","29208","United States",[102],{"name":103,"role":104,"phone":105,"email":106},"Elizabeth Regan","CONTACT","7046092409","eregan@mailbox.sc.edu",{"lat":108,"lon":109},34.00071,-81.03481,{"facility":111,"status":7,"city":112,"state":98,"zip":113,"country":100,"contacts":114,"geoPoint":118},"Sumter YMCA","Sumter","29150",[115],{"name":116,"role":104,"phone":117,"email":106},"Elizabeth Regan, DPT, PhD","704-609-2409",{"lat":119,"lon":120},33.92044,-80.34147,[122,124],{"name":123,"role":104,"phone":105,"email":106},"Elizabeth Regan, PhD",{"name":125,"role":104,"phone":126,"email":127},"Amberly Osteen","(803) 216-3896","Amberly.osteen@uscmed.sc.edu",[],[],[],{"nct_id":4,"conditions":132,"biomarkers":134},[133],"Cognitive Dysfunction",[],{"nct_id":4,"found":136,"summary":137,"prompt_version":147},true,{"design":138,"status":139,"heading":140,"summary":141,"follow_up":142,"word_count":143,"commitments":144,"compensation":145,"drugs_mentioned":146},"This is an interventional study, meaning participants will receive a specific intervention. It aims to enroll 50 participants.","completed","Train Your Brain Fitness SC: Exercise for Cognitive Impairments","This study, called \"Train Your Brain Fitness SC,\" is testing an exercise and coaching program for adults in South Carolina who have mild to moderate cognitive impairment. The program involves supervised exercise and behavior modification support, aiming for 60 minutes of moderate intensity exercise twice a week. This includes cardiovascular activity and functional strength training. The main goal is to see if the program is practical to run, if people enjoy it, and if it helps improve endurance, mobility, and cognitive function over 3, 6, 9, and 12 months. You might be able to join if you are an adult with a medical diagnosis of mild-moderate cognitive impairment, have medical clearance for exercise, and can follow two-step commands. The study plans to enroll 50 participants.","Changes in endurance, mobility, and cognitive function will be measured at 3, 6, 9, and 12 months.",125,"Participants will attend exercise sessions twice a week. These sessions will involve endurance, strength, balance, and mobility training, with coaches providing plans and monitoring progress.","Not stated in the trial record.",[32],"v2"]