At-Home Cardiac Rehabilitation for Adolescents At Risk for Heart Failure

Children's Hospital Los Angeles

Status

Enrolling

Conditions

Cardiovascular Complication

Chemotherapeutic Toxicity

Treatments

Behavioral: Cardio-oncology rehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT06826534

CHLA-22-00323

Details and patient eligibility

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.

Enrollment

20 estimated patients

Sex

All

Ages

Under 21 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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