[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06826534":3,"trial-entities:NCT06826534":145,"trial-summary:NCT06826534":150},{"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":20,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":40,"secondary_outcomes":75,"sex":85,"minimum_age":86,"maximum_age":87,"healthy_volunteers":14,"eligibility_criteria":88,"std_ages":114,"locations":117,"central_contacts":138,"overall_officials":141,"references":143,"see_also_links":144},"NCT06826534","CHLA-22-00323","At-Home Cardiac Rehabilitation for Adolescents at Risk for Heart Failure","RECRUITING","2025-12-31","2025-02","2025-02-14","2023-10-20","Children's Hospital Los Angeles","OTHER",false,"The goal of this clinical trial is to explore the impact that an at-home cardio-oncology rehabilitation (CORE) may have on short-term cardiovascular fitness and psychosocial wellness in pediatric cancer survivors. The main question it aims to answer are\n\n* To evaluate the efficacy of an at-home CORE model on short-term cardiovascular fitness and psychosocial wellbeing in adolescent cancer survivors.\n* To evaluate the exercise adherence rate among adolescents at risk for heart failure and assess barriers to compliance.\n* To explore which specific CORE resources are of most value to patients in creating sustainable healthy lifestyle modifications.\n* Hypothesis: Pediatric cancer survivors who implement exercise and dietary recommendations will demonstrate improvement in cardiovascular fitness and general wellness. A multidisciplinary team approach can facilitate adherence to a moderately rigorous exercise prescription, and thus enhance the health benefits of a CORE program at CHLA.\n\nParticipants will undergo cardiovascular studies and a quality-of-life survey prior to exercise intervention, and at the end of the 6-month study period.",null,[18,19],"Cardiovascular Complication","Chemotherapeutic Toxicity",[21,22,23,24,25],"anthracycline exposure","cancer survivors","physical activity","pediatric oncology","cardiac rehabilitation","INTERVENTIONAL","TREATMENT",[29],"NA",{"count":31,"type":32},20,"ESTIMATED",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38},"BEHAVIORAL","Cardio-oncology rehabilitation","Least 60 minutes of physical activity each day including vigorous-intensity and strengthening activities at least 3 days per week",[39],"Treatment Arm",[41,45,47,49,51,54,57,60,63,66,69,72],{"measure":42,"description":43,"timeFrame":44},"Change in cardiovascular fitness after completion of a 6-month exercise intervention.","Peak VO2% (exercise capacity) as measured by cardiopulmonary exercise testing.","Baseline to 6 months",{"measure":42,"description":46,"timeFrame":44},"Ve\u002FVCO2 slope (predictor of cardiac mortality) as measured by cardiopulmonary exercise testing.",{"measure":42,"description":48,"timeFrame":44},"Chronotropic response (heart rate response to exercise) as measured by cardiopulmonary exercise testing.",{"measure":42,"description":50,"timeFrame":44},"Blood pressure response to exercise as measured by cardiopulmonary exercise testing.",{"measure":52,"description":53,"timeFrame":44},"Change in cardiac function after completion of a 6-month exercise intervention.","Cardiac function will be assessed via echocardiogram.",{"measure":55,"description":56,"timeFrame":44},"Change in cardiac rhythm after completion of a 6-month exercise intervention.","Cardiac rhythm will be assessed via EKG.",{"measure":58,"description":59,"timeFrame":44},"Change in cardiac stress after completion of a 6-month exercise intervention.","Cardiac stress will be assessed via NT-proBNP level.",{"measure":61,"description":62,"timeFrame":44},"Average change in triglyceride level as measured from baseline to 6 months.","Triglyceride (mg\u002FdL) will be measured.",{"measure":64,"description":65,"timeFrame":44},"Average change in total cholesterol level as measured from baseline to 6 months.","Total cholesterol (mg\u002FdL) will be measured.",{"measure":67,"description":68,"timeFrame":44},"Average change in high density lipoprotein level as measured from baseline to 6 months.","High density lipoprotein (HDL) (mg\u002FdL) will be measured.",{"measure":70,"description":71,"timeFrame":44},"Average change in low density lipoprotein as measured from baseline to 6 months.","Low density lipoprotein (LDL) (mg\u002FdL) will be measured.",{"measure":73,"description":74,"timeFrame":44},"Average change in very low density lipoprotein as measured from baseline to 6 months.","Very low density lipoprotein (VLDL) (mg\u002FdL) will be measured.",[76,79,82],{"measure":77,"description":78,"timeFrame":44},"Average change in reported quality of life from baseline to 6 months","PedsQL(TM) Measurement Model will be used, which assesses physical, emotional, social, school functioning domains.",{"measure":80,"description":81,"timeFrame":44},"Percent of participants with improvement in healthy lifestyle habits from baseline to 6 months","Lifestyle habits will be assessed via exercise and dietary surveys completed by each participant.",{"measure":83,"description":84,"timeFrame":44},"Average change in activity level from baseline to 6 months","Activity levels will be assessed via exercise surveys as well as continuous FitBit(TM) activity data which will include weekly number of steps, average calorie burn, days of exercise, minute in activity, and average sleep time.","ALL","0 Years","21 Years",{"inclusion":89,"exclusion":100,"raw_text":113},[90,91,92,93,94,95,96,97,98,99],"Patients aged of 10-21 years at enrollment","Parent\u002Flegal guardian available for consent (if applicable), and patient available for assent and consent","History of anthracycline exposure +\u002F- radiation","Currently in remission, with at least 6 months off chemotherapy","Able to perform CPET","Baseline CPET with VO2 \\\u003C80% (at start of study, or CPET at CHLA after January 2020)","Smartphone compatible with Fitbit (own or parent\u002Flegal guardian's)","Ability to complete and send diary and Fitbit information on a weekly basis","Ability to participate in monthly virtual check-in visits","Baseline activity prior to intervention \\\u003C30min\u002Fday, 2x\u002Fweek",[101,102,103,104,105,106,107,108,109,110,111,112],"Inability to obtain consent\u002Fassent","Unable to accurately perform quality of life survey independently","No other primary medical diagnosis (e.g., Down Syndrome, Wolff-Parkinson-White Syndrome, congenital heart disease) or history of cardiothoracic surgery","Contraindication to moderate activity (\\>3 METs). Examples include history of malignant arrhythmias, exercise-induced syncope, severe symptoms of HF (NYHA IV, ACC\u002FAHA Stage D)","Unable to perform CPET, echocardiogram, EKG, or obtain laboratory studies","Unable to perform mild activity for at least 0.5h\u002Fday and at least 2x\u002Fweek","Unable to come to hospital for study visits at 0 and 6 months","Unable to complete study-related surveys","Unable to complete and send diary and Fitbit information on a weekly basis","Unable to check-in monthly on virtual platform","On beta blockade","Pregnancy","INCLUSION CRITERIA\n\n* Patients aged of 10-21 years at enrollment\n* Parent\u002Flegal guardian available for consent (if applicable), and patient available for assent and consent\n* History of anthracycline exposure +\u002F- radiation\n* Currently in remission, with at least 6 months off chemotherapy\n* Able to perform CPET\n* Baseline CPET with VO2 \\\u003C80% (at start of study, or CPET at CHLA after January 2020)\n* Smartphone compatible with Fitbit (own or parent\u002Flegal guardian's)\n* Ability to complete and send diary and Fitbit information on a weekly basis\n* Ability to participate in monthly virtual check-in visits\n* Baseline activity prior to intervention \\\u003C30min\u002Fday, 2x\u002Fweek\n\nEXCLUSION CRITERIA\n\n* Inability to obtain consent\u002Fassent\n* Unable to accurately perform quality of life survey independently\n* No other primary medical diagnosis (e.g., Down Syndrome, Wolff-Parkinson-White Syndrome, congenital heart disease) or history of cardiothoracic surgery\n* Contraindication to moderate activity (\\>3 METs). Examples include history of malignant arrhythmias, exercise-induced syncope, severe symptoms of HF (NYHA IV, ACC\u002FAHA Stage D)\n* Unable to perform CPET, echocardiogram, EKG, or obtain laboratory studies\n* Unable to perform mild activity for at least 0.5h\u002Fday and at least 2x\u002Fweek\n* Unable to come to hospital for study visits at 0 and 6 months\n* Unable to complete study-related surveys\n* Unable to complete and send diary and Fitbit information on a weekly basis\n* Unable to check-in monthly on virtual platform\n* On beta blockade\n* Pregnancy",[115,116],"CHILD","ADULT",[118],{"facility":12,"status":7,"city":119,"state":120,"zip":121,"country":122,"contacts":123,"geoPoint":135},"Los Angeles","California","90027","United States",[124,129,133],{"name":125,"role":126,"phone":127,"email":128},"Obdulio Carreras","CONTACT","(323) 361-4663","ocarreras@chla.usc.edu",{"name":130,"role":126,"phone":131,"email":132},"Jennifer Su, MD","(323) 361-5136","jsu@chla.usc.edu",{"name":130,"role":134},"PRINCIPAL_INVESTIGATOR",{"lat":136,"lon":137},34.05223,-118.24368,[139,140],{"name":125,"role":126,"phone":127,"email":128},{"name":130,"role":126,"phone":131,"email":132},[142],{"name":130,"affiliation":12,"role":134},[],[],{"nct_id":4,"conditions":146,"biomarkers":149},[147,148],"Heart Failure","Malignant Neoplasm",[],{"nct_id":4,"found":151,"summary":152,"prompt_version":161},true,{"design":153,"status":154,"heading":6,"summary":155,"follow_up":156,"word_count":157,"commitments":158,"compensation":159,"drugs_mentioned":160},"This is an interventional study planning to enroll 20 participants. The study is testing a behavioral intervention called cardio-oncology rehabilitation.","completed","This study is looking at how an at-home cardio-oncology rehabilitation (CORE) program can help adolescent cancer survivors who are at risk for heart failure. The program involves at least 60 minutes of physical activity each day, including vigorous exercise and strengthening activities at least three times a week. The goal is to see if this program improves your heart fitness and overall well-being. Researchers also want to understand how well participants stick to the exercise plan and what resources are most helpful. You may be able to join if you are between 10 and 21 years old, have a history of certain cancer treatments, are in remission, and meet specific heart fitness criteria. The study aims to measure changes in heart fitness after six months.","Your cardiovascular fitness will be measured at the beginning of the study and again after 6 months.",125,"You would participate in a 6-month exercise intervention, which includes at least 60 minutes of physical activity daily, with vigorous-intensity and strengthening activities at least 3 days per week.","Not stated in the trial record.",[36],"v2"]