Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-26 @ 5:10 PM
Study NCT ID:
NCT06826534
Status:
RECRUITING
Last Update Posted:
2025-02-14
First Post:
2025-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
At-Home Cardiac Rehabilitation for Adolescents at Risk for Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-12', 'studyFirstSubmitDate': '2025-01-31', 'studyFirstSubmitQcDate': '2025-02-12', 'lastUpdatePostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in cardiovascular fitness after completion of a 6-month exercise intervention.', 'timeFrame': 'Baseline to 6 months', 'description': 'Peak VO2% (exercise capacity) as measured by cardiopulmonary exercise testing.'}, {'measure': 'Change in cardiovascular fitness after completion of a 6-month exercise intervention.', 'timeFrame': 'Baseline to 6 months', 'description': 'Ve/VCO2 slope (predictor of cardiac mortality) as measured by cardiopulmonary exercise testing.'}, {'measure': 'Change in cardiovascular fitness after completion of a 6-month exercise intervention.', 'timeFrame': 'Baseline to 6 months', 'description': 'Chronotropic response (heart rate response to exercise) as measured by cardiopulmonary exercise testing.'}, {'measure': 'Change in cardiovascular fitness after completion of a 6-month exercise intervention.', 'timeFrame': 'Baseline to 6 months', 'description': 'Blood pressure response to exercise as measured by cardiopulmonary exercise testing.'}, {'measure': 'Change in cardiac function after completion of a 6-month exercise intervention.', 'timeFrame': 'Baseline to 6 months', 'description': 'Cardiac function will be assessed via echocardiogram.'}, {'measure': 'Change in cardiac rhythm after completion of a 6-month exercise intervention.', 'timeFrame': 'Baseline to 6 months', 'description': 'Cardiac rhythm will be assessed via EKG.'}, {'measure': 'Change in cardiac stress after completion of a 6-month exercise intervention.', 'timeFrame': 'Baseline to 6 months', 'description': 'Cardiac stress will be assessed via NT-proBNP level.'}, {'measure': 'Average change in triglyceride level as measured from baseline to 6 months.', 'timeFrame': 'Baseline to 6 months', 'description': 'Triglyceride (mg/dL) will be measured.'}, {'measure': 'Average change in total cholesterol level as measured from baseline to 6 months.', 'timeFrame': 'Baseline to 6 months', 'description': 'Total cholesterol (mg/dL) will be measured.'}, {'measure': 'Average change in high density lipoprotein level as measured from baseline to 6 months.', 'timeFrame': 'Baseline to 6 months', 'description': 'High density lipoprotein (HDL) (mg/dL) will be measured.'}, {'measure': 'Average change in low density lipoprotein as measured from baseline to 6 months.', 'timeFrame': 'Baseline to 6 months', 'description': 'Low density lipoprotein (LDL) (mg/dL) will be measured.'}, {'measure': 'Average change in very low density lipoprotein as measured from baseline to 6 months.', 'timeFrame': 'Baseline to 6 months', 'description': 'Very low density lipoprotein (VLDL) (mg/dL) will be measured.'}], 'secondaryOutcomes': [{'measure': 'Average change in reported quality of life from baseline to 6 months', 'timeFrame': 'Baseline to 6 months', 'description': 'PedsQL(TM) Measurement Model will be used, which assesses physical, emotional, social, school functioning domains.'}, {'measure': 'Percent of participants with improvement in healthy lifestyle habits from baseline to 6 months', 'timeFrame': 'Baseline to 6 months', 'description': 'Lifestyle habits will be assessed via exercise and dietary surveys completed by each participant.'}, {'measure': 'Average change in activity level from baseline to 6 months', 'timeFrame': 'Baseline to 6 months', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anthracycline exposure', 'cancer survivors', 'physical activity', 'pediatric oncology', 'cardiac rehabilitation'], 'conditions': ['Cardiovascular Complication', 'Chemotherapeutic Toxicity']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "INCLUSION CRITERIA\n\n* Patients aged of 10-21 years at enrollment\n* Parent/legal guardian available for consent (if applicable), and patient available for assent and consent\n* History of anthracycline exposure +/- radiation\n* Currently in remission, with at least 6 months off chemotherapy\n* Able to perform CPET\n* Baseline CPET with VO2 \\<80% (at start of study, or CPET at CHLA after January 2020)\n* Smartphone compatible with Fitbit (own or parent/legal 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 \\<30min/day, 2x/week\n\nEXCLUSION CRITERIA\n\n* Inability to obtain consent/assent\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/AHA Stage D)\n* Unable to perform CPET, echocardiogram, EKG, or obtain laboratory studies\n* Unable to perform mild activity for at least 0.5h/day and at least 2x/week\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"}, 'identificationModule': {'nctId': 'NCT06826534', 'briefTitle': 'At-Home Cardiac Rehabilitation for Adolescents at Risk for Heart Failure', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Los Angeles"}, 'officialTitle': 'At-Home Cardiac Rehabilitation for Adolescents at Risk for Heart Failure', 'orgStudyIdInfo': {'id': 'CHLA-22-00323'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Arm', 'interventionNames': ['Behavioral: Cardio-oncology rehabilitation']}], 'interventions': [{'name': 'Cardio-oncology rehabilitation', 'type': 'BEHAVIORAL', 'description': 'Least 60 minutes of physical activity each day including vigorous-intensity and strengthening activities at least 3 days per week', 'armGroupLabels': ['Treatment Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Obdulio Carreras', 'role': 'CONTACT', 'email': 'ocarreras@chla.usc.edu', 'phone': '(323) 361-4663'}, {'name': 'Jennifer Su, MD', 'role': 'CONTACT', 'email': 'jsu@chla.usc.edu', 'phone': '(323) 361-5136'}, {'name': 'Jennifer Su, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'centralContacts': [{'name': 'Obdulio Carreras', 'role': 'CONTACT', 'email': 'ocarreras@chla.usc.edu', 'phone': '(323) 361-4663'}, {'name': 'Jennifer Su, MD', 'role': 'CONTACT', 'email': 'jsu@chla.usc.edu', 'phone': '(323) 361-5136'}], 'overallOfficials': [{'name': 'Jennifer Su, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Los Angeles"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Los Angeles", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Keck School of Medicine, University of Southern California', 'investigatorFullName': 'Jennifer Su', 'investigatorAffiliation': "Children's Hospital Los Angeles"}}}}