Clinical trial NCT06826534: At-Home Cardiac Rehabilitation for Adolescents at Risk for Heart Failure
Official title: At-Home Cardiac Rehabilitation for Adolescents at Risk for Heart Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Complication
Chemotherapeutic Toxicity
Keywords: anthracycline exposure
cancer survivors
physical activity
pediatric oncology
cardiac rehabilitation
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 20
Sex: ALL
Minimum age (years): 0
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

Primary outcomes:
measure: Change in cardiovascular fitness after completion of a 6-month exercise intervention.
timeFrame: Baseline to 6 months
measure: Change in cardiovascular fitness after completion of a 6-month exercise intervention.
timeFrame: Baseline to 6 months
measure: Change in cardiovascular fitness after completion of a 6-month exercise intervention.
timeFrame: Baseline to 6 months
measure: Change in cardiovascular fitness after completion of a 6-month exercise intervention.
timeFrame: Baseline to 6 months
measure: Change in cardiac function after completion of a 6-month exercise intervention.
timeFrame: Baseline to 6 months
measure: Change in cardiac rhythm after completion of a 6-month exercise intervention.
timeFrame: Baseline to 6 months
measure: Change in cardiac stress after completion of a 6-month exercise intervention.
timeFrame: Baseline to 6 months
measure: Average change in triglyceride level as measured from baseline to 6 months.
timeFrame: Baseline to 6 months
measure: Average change in total cholesterol level as measured from baseline to 6 months.
timeFrame: Baseline to 6 months
measure: Average change in high density lipoprotein level as measured from baseline to 6 months.
timeFrame: Baseline to 6 months
measure: Average change in low density lipoprotein as measured from baseline to 6 months.
timeFrame: Baseline to 6 months
measure: Average change in very low density lipoprotein as measured from baseline to 6 months.
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Average change in reported quality of life from baseline to 6 months
timeFrame: Baseline to 6 months
measure: Percent of participants with improvement in healthy lifestyle habits from baseline to 6 months
timeFrame: Baseline to 6 months
measure: Average change in activity level from baseline to 6 months
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: Jennifer Su, MD
role: PRINCIPAL_INVESTIGATOR
References: