At-Home Cardiac Rehabilitation for Adolescents at Risk for Heart Failure
Recruiting · NCT06826534 · Interventional (participants receive a specific treatment) · Lead sponsor: Children's Hospital Los Angeles
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
1 location listed across 1 US state.
- Children's Hospital Los Angeles - Los Angeles, California, United States