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At-Home Cardiac Rehabilitation for Adolescents at Risk for Heart Failure
NCT06826534 · Children's Hospital Los Angeles
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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
* To evaluate the efficacy of an at-home CORE model on short-term cardiovascular fitness and psychosocial wellbeing in adolescent cancer survivors.
* To evaluate the exercise adherence rate among adolescents at risk for heart failure and assess barriers to compliance.
* To explore which specific CORE resources are of most value to patients in creating sustainable healthy lifestyle modifications.
* 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.
Participants will undergo cardiovascular studies and a quality-of-life survey prior to exercise intervention, and at the end of the 6-month study period.
Eligibility criteria
INCLUSION CRITERIA
* Patients aged of 10-21 years at enrollment
* Parent/legal guardian available for consent (if applicable), and patient available for assent and consent
* History of anthracycline exposure +/- radiation
* Currently in remission, with at least 6 months off chemotherapy
* Able to perform CPET
* Baseline CPET with VO2 \<80% (at start of study, or CPET at CHLA after January 2020)
* Smartphone compatible with Fitbit (own or parent/legal 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 \<30min/day, 2x/week
EXCLUSION CRITERIA
* Inability to obtain consent/assent
* 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/AHA Stage D)
* Unable to perform CPET, echocardiogram, EKG, or obtain laboratory studies
* Unable to perform mild activity for at least 0.5h/day and at least 2x/week
* 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
Study design
Enrollment target: 20 participants
Allocation: na
Masking: none
Age groups: child, adult
Timeline
Starts: 2023-10-20
Estimated completion: 2025-12-31
Last updated: 2025-02-14
Interventions
Behavioral: Cardio-oncology rehabilitation
Primary outcomes
- • Change in cardiovascular fitness after completion of a 6-month exercise intervention. (Baseline to 6 months)
- • Change in cardiovascular fitness after completion of a 6-month exercise intervention. (Baseline to 6 months)
- • Change in cardiovascular fitness after completion of a 6-month exercise intervention. (Baseline to 6 months)
Sponsor
Children's Hospital Los Angeles · other
Contacts & investigators
ContactObdulio Carreras · contact · ocarreras@chla.usc.edu · (323) 361-4663
ContactJennifer Su, MD · contact · jsu@chla.usc.edu · (323) 361-5136
InvestigatorJennifer Su, MD · principal_investigator, Children's Hospital Los Angeles
All locations (1)
Children's Hospital Los AngelesRecruiting
Los Angeles, California, United States