At-Home Cardiac Rehabilitation for Adolescents at Risk for Heart Failure
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 0 Years to 21 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official 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 sites (1)
CA
- Children's Hospital Los Angeles · Los Angeles, CA 90027Obdulio Carreras · Study contact · (323) 361-4663 · ocarreras@chla.usc.eduJennifer Su, MD · Study contact · (323) 361-5136 · jsu@chla.usc.eduJennifer Su, MD · Principal investigatorMore trials in Los Angeles