[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06028334":3,"trial-entities:NCT06028334":150,"trial-summary:NCT06028334":154},{"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":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":42,"secondary_outcomes":51,"sex":97,"minimum_age":98,"maximum_age":99,"healthy_volunteers":15,"eligibility_criteria":100,"std_ages":117,"locations":120,"central_contacts":134,"overall_officials":142,"references":144,"see_also_links":149},"NCT06028334","iRISID-2023-1533","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","RECRUITING","2027-08-31","2025-02","2025-03-20","2023-12-19","Albert Einstein Healthcare Network","OTHER",false,"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?","The investigators will conduct a Randomized Controlled Trial (RCT) of a novel, remotely delivered physical activity (PA) promotion program, called GetUp\\&Go-a name selected by focus group participants with moderate-to-severe traumatic brain injury (msTBI). It will be theoretically based, use objective measurement of PA as a primary outcome, and incorporate varied types and amounts of home- and neighborhood-based PA and ways to reduce sedentary behavior, according to participant preferences. Moreover, using a 2-phase design as described below, the investigators will test a method for enhancing longer-term gains in PA using mobile technology, in addition to gains acquired during the first phase of intervention.\n\nTrial design. Participants will undergo baseline testing (T1) and will then be randomized 1:1 to either immediate treatment in GetUp\\&Go (IT) or waitlist (WL) for 10 weeks. After testing for the primary outcome (T2), the waitlist group will receive GetUp\\&Go for 10 weeks followed by a T2b evaluation for that group. This phase is called the \"A phase\", for Acquisition.\n\nFollowing completion of the GetUp\\&Go intervention, all participants-regardless of initial group allocation-will be randomized 1:1 to one of two conditions for an additional 10 weeks, the \"Follow-Through\" (FT) phase. Half of participants will be randomized to the RehaBot condition (RB), which provides continued use of the chatbot to support individualized PA plans, but with no further therapist contact. Participants in the No RehaBot (No RB) condition will not have access to the chatbot. The final evaluation, T3, will occur after the 10-week Follow-Through phase.",[19],"Traumatic Brain Injury",[21,22],"physical activity","mobile health","INTERVENTIONAL","TREATMENT",[26],"NA",{"count":28,"type":29},70,"ESTIMATED",[31,37],{"type":32,"name":33,"description":34,"armGroupLabels":35},"BEHAVIORAL","GetUp&Go","A behavioral treatment combining personalized activity planning and a mobile health application for supporting adherence to activity plans.",[36],"Immediate Treatment",{"type":32,"name":38,"description":39,"armGroupLabels":40},"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.",[41],"Waitlist",[43,47,49],{"measure":44,"description":45,"timeFrame":46},"Average activity counts\u002Fminute","Actigraphy derived average activity counts\u002Fminute from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period","Baseline",{"measure":44,"description":45,"timeFrame":48},"10 weeks after initial randomization",{"measure":44,"description":45,"timeFrame":50},"10 weeks after completing GetUp&Go intervention",[52,55,56,57,60,61,62,65,66,67,70,71,72,75,76,77,80,81,82,85,86,87,90,91,92,95,96],{"measure":53,"description":54,"timeFrame":46},"Percent (%) time sedentary","Actigraphy derived percent time sedentary from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period",{"measure":53,"description":54,"timeFrame":48},{"measure":53,"description":54,"timeFrame":50},{"measure":58,"description":59,"timeFrame":46},"Percent (%) time engaged in moderate-vigorous physical activity (MVPA)","Actigraphy derived percent time engaged in MVPA from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period",{"measure":58,"description":59,"timeFrame":48},{"measure":58,"description":59,"timeFrame":50},{"measure":63,"description":64,"timeFrame":46},"Average daily step count","Actigraphy derived average daily step count from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period",{"measure":63,"description":64,"timeFrame":48},{"measure":63,"description":64,"timeFrame":50},{"measure":68,"description":69,"timeFrame":46},"Self-reported PA","Physical Activity Scale for Individuals with Physical Disabilities (Scale: 0-100, where higher scores indicate a greater level of activity)",{"measure":68,"description":69,"timeFrame":48},{"measure":68,"description":69,"timeFrame":50},{"measure":73,"description":74,"timeFrame":46},"Emotional function","Brief Symptom Inventory-18 (Scale: 0-72, where higher scores indicate the presence of more psychiatric symptoms)",{"measure":73,"description":74,"timeFrame":48},{"measure":73,"description":74,"timeFrame":50},{"measure":78,"description":79,"timeFrame":46},"Fatigue","Fatigue Severity Scale Short Form (Scale: 9-63, where higher scores indicate greater fatigue)",{"measure":78,"description":79,"timeFrame":48},{"measure":78,"description":79,"timeFrame":50},{"measure":83,"description":84,"timeFrame":46},"Sleep Quality","Pittsburgh Sleep Quality Index (Scale: 0-21, where higher scores indicate poorer sleep quality)",{"measure":83,"description":84,"timeFrame":48},{"measure":83,"description":84,"timeFrame":50},{"measure":88,"description":89,"timeFrame":46},"Subjective pain","Brief Pain Interference Scale (Scale: 6-30, where higher scores indicate greater pain interference)",{"measure":88,"description":89,"timeFrame":48},{"measure":88,"description":89,"timeFrame":50},{"measure":93,"description":94,"timeFrame":46},"Health-related Quality of Life","Quality of Life after Brain Injury Scale (Scale: 0-100, where higher scores indicate better quality of life)",{"measure":93,"description":94,"timeFrame":48},{"measure":93,"description":94,"timeFrame":50},"ALL","18 Years",null,{"inclusion":101,"exclusion":108,"raw_text":116},[102,103,104,105,106,107],"Age ≥18","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","Fully weight bearing on lower limbs and able to walk indoors and outdoors without the assistance of another person","Cognitively able to participate in treatment as judged by ability to travel independently within the community","Able to communicate adequately in English for participation in the treatment protocols","Informed consent given by participant",[109,110,111,112,113,114,115],"Contraindications to increasing PA as judged by study physician, using an exam based on published screening tools","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","Significant physical or intellectual disability predating the TBI","Neurodegenerative disorder, e.g., Parkinson's disease","Insufficiently inactive, i.e., reporting \\> 23 weekly moderate\u002Fvigorous activity units on the Godin Leisure-Time Exercise Questionnaire","Planned surgery or other hospitalization during the succeeding 9 months","Physical or sensory disability (e.g., blindness; severe bimanual incoordination) that prevents use of a smartphone","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",[118,119],"ADULT","OLDER_ADULT",[121],{"facility":122,"status":8,"city":123,"state":124,"zip":125,"country":126,"contacts":127,"geoPoint":131},"Moss Rehabilitation Research Institute","Elkins Park","Pennsylvania","19027","United States",[128],{"name":129,"role":130},"Amanda Rabinowitz, PhD","PRINCIPAL_INVESTIGATOR",{"lat":132,"lon":133},40.07706,-75.12684,[135,139],{"name":129,"role":136,"phone":137,"email":138},"CONTACT","215 663-6526","amanda.rabinowitz@jefferson.edu",{"name":140,"role":136,"email":141},"Lauren Krasucki, DPT, MPH","lauren.krasucki@jefferson.edu",[143],{"name":129,"affiliation":13,"role":130},[145],{"pmid":146,"type":147,"citation":148},"41705067","DERIVED","Hart T, Vaccaro M, Krasucki L, Chervoneva I, Rabinowitz A. Increasing physical activity in moderate-severe traumatic brain injury: protocol for a two-stage randomized controlled trial of a remote, mHealth-enhanced intervention. Front Rehabil Sci. 2026 Feb 2;7:1656326. doi: 10.3389\u002Ffresc.2026.1656326. eCollection 2026.",[],{"nct_id":4,"conditions":151,"biomarkers":153},[152],"Traumatic Encephalopathy",[],{"nct_id":4,"found":155,"summary":156,"prompt_version":166},true,{"design":157,"status":158,"heading":159,"summary":160,"follow_up":161,"word_count":162,"commitments":163,"compensation":164,"drugs_mentioned":165},"This is a randomized controlled trial with 70 planned participants. You would be randomly assigned to either receive the GetUp&Go program right away or be on a waitlist for 10 weeks before receiving it.","completed","GetUp&Go: Increasing Physical Activity After Traumatic Brain Injury","This study is testing a program called GetUp&Go, designed to help people increase their physical activity after a traumatic brain injury (TBI). GetUp&Go is a 10-week program delivered remotely, which means you can participate from home. It includes one-on-one sessions with a therapist and a mobile app called RehaBot to help you stick to your activity plans. The main goal is to see if participants using GetUp&Go become more physically active compared to those who are on a waitlist. Researchers will measure activity levels and also look at how the program might improve mental and physical health. You may be able to join if you are at least 18 years old and had a moderate-to-severe TBI at least six months ago. The current status of the study is unclear.","After completing the GetUp&Go intervention, all participants will be followed for an additional 10 weeks.",129,"You would participate in a 10-week GetUp&Go program, which includes one-on-one sessions with a therapist and using a mobile health application. Your activity levels would be measured at the beginning, after 10 weeks, and again after completing the GetUp&Go intervention.","Not stated in the trial record.",[33],"v2"]