[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100518268":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":43,"responsibleParty":60,"collaborators":63,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":26,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":26,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":46,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Albert Einstein Healthcare Network","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Immediate Treatment","EXPERIMENTAL","The 10-week GetUp\\&Go intervention will be delivered entirely remotely, with 2 weekly sessions with a therapist delivered over videoconference (Zoom for Healthcare) followed by 3 sessions in weeks 3, 5, and 8, over Zoom or phone according to participant preference.\n\nThe overall goal of the intervention is to develop and support a personalized plan to increase physical activity and decrease sedentary behavior, in concert with the unique capabilities, opportunities, and motivational factors of each participant. In session 2 and thereafter, RehaBot will be supplied to participants to deliver therapeutic ingredients to supplement those provided by the therapist.",[13],"Behavioral: GetUp&Go",{"label":15,"type":16,"description":17,"interventionNames":18},"Waitlist","PLACEBO_COMPARATOR","A 10-week waitlist with baseline and outcome assessment, followed by receipt of the full GetUp\\&Go program.",[19],"Behavioral: GetUp&Go with 10-Week Delay",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","GetUp&Go","A behavioral treatment combining personalized activity planning and a mobile health application for supporting adherence to activity plans.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"GetUp&Go with 10-Week Delay","No assigned treatment during the waitlist phase. Participants in the WL group will be offered the GetUp\\&Go intervention, which combines personalized activity planning and a mobile health application, after collection of the primary outcome measure.",[15],[32],{"name":33,"affiliation":5,"role":34},"Amanda Rabinowitz, PhD","PRINCIPAL_INVESTIGATOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","215 663-6526","amanda.rabinowitz@jefferson.edu",{"name":41,"role":37,"phone":26,"phoneExt":26,"email":42},"Lauren Krasucki, DPT, MPH","lauren.krasucki@jefferson.edu",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Moss Rehabilitation Research Institute","RECRUITING","Elkins Park","Pennsylvania","19027","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-75.12684,40.07706,{"lat":56,"lon":55},[59],{"name":33,"role":34,"phone":26,"phoneExt":26,"email":26},{"type":34,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Amanda Rabinowitz","Institute Scientist",[64],{"name":65,"class":66},"National Institute on Disability, Independent Living, and Rehabilitation Research","FED","100518268","getupgo-a-randomized-controlled-trial-of-an-intervention-to-enhance-physical-activity-after-tbi-100518268",false,"NCT06028334","GetUp&Go: A Randomized Controlled Trial of an Intervention to Enhance Physical Activity After TBI","GetUp&Go: A Randomized Controlled Trial of a Theory-Based Intervention to Enhance Physical Activity in Chronic, Moderate-Severe Traumatic Brain Injury","Inclusion Criteria:\n\n* Age ≥18\n* TBI (open or closed), sustained at least 6 months prior to enrollment, of at least complicated-mild\u002Fmoderate severity as evidenced by loss or alteration of consciousness ≥ 30 minutes; and\u002For post-traumatic amnesia (PTA) ≥ 24 hours, not due to intoxication\u002Fsedation and documented prospectively from the injury; and\u002For positive neuroimaging findings consistent with TBI\n* Fully weight bearing on lower limbs and able to walk indoors and outdoors without the assistance of another person\n* Cognitively able to participate in treatment as judged by ability to travel independently within the community\n* Able to communicate adequately in English for participation in the treatment protocols\n* Informed consent given by participant\n\nExclusion Criteria:\n\n* Contraindications to increasing PA as judged by study physician, using an exam based on published screening tools\n* Medical or psychiatric instability, including current psychosis or severe uncontrolled substance misuse, as assessed using items from the SCID\u002FMINI\u002FASSIST, or suicidal ideation with intent or plan, as assessed by the Columbia-Suicide Severity Rating Scale, screening version\n* Significant physical or intellectual disability predating the TBI\n* Neurodegenerative disorder, e.g., Parkinson's disease\n* Insufficiently inactive, i.e., reporting \\> 23 weekly moderate\u002Fvigorous activity units on the Godin Leisure-Time Exercise Questionnaire\n* Planned surgery or other hospitalization during the succeeding 9 months\n* Physical or sensory disability (e.g., blindness; severe bimanual incoordination) that prevents use of a smartphone","ALL","18 Years",{"count":77,"type":78},70,"ESTIMATED","INTERVENTIONAL",[81],"NA","The goal of this clinical trial is to evaluate GetUp\\&Go, a program for promoting increased physical activity in individuals at least 6 months post moderate-to-severe traumatic brain injury. GetUp\\&Go is a remotely delivered 10-week program that includes one-on-one sessions with a therapist and a mobile health application (RehaBot).\n\nThe main question is whether participants in the 10-week GetUp\\&Go program increase their physical activity, and exhibit associated benefits in mental and physical health, relative to those who are put on a waitlist.\n\n* Question 1: Do participants who receive immediate treatment with GetUp\\&Go show more increased physical activity, measured by accelerometer activity counts per day, and improve more on secondary outcomes, such as self-reported physical activity, emotional function, fatigue, sleep, pain, and health-related quality of life, compared to their baseline, relative to those who are put on a waitlist?\n* Question 2: Do participants who have continued access to the mobile health component of the intervention, RehaBot, show better maintenance of physical activity gains compared to those who no longer have access to RehaBot?\n* Question 3: Are individual participant characteristics associated with participants' response to the treatment program?",[84],"Traumatic Brain Injury",[86,87],"physical activity","mobile health","2025-03-18",{"date":90,"type":91},"2025-03-20","ACTUAL",{"date":93,"type":91},"2023-12-19",{"date":95,"type":78},"2027-08-31",{"name":5,"class":6},1]