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

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.

Study Overview

• Status: Recruiting
• Conditions: Chemotherapeutic Toxicity; Cardiovascular Complication
• Intervention / Treatment: Behavioral: Cardio-oncology rehabilitation

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Obdulio Carreras; Phone Number: (323) 361-4663; Email: ocarreras@chla.usc.edu
• Study Contact Backup: Name: Jennifer Su, MD; Phone Number: (323) 361-5136; Email: jsu@chla.usc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Recruiting
      • Children's Hospital Los Angeles
      • Contact: Obdulio Carreras; Phone Number: (323) 361-4663; Email: ocarreras@chla.usc.edu
      • Contact: Jennifer Su, MD; Phone Number: (323) 361-5136; Email: jsu@chla.usc.edu
      • Contact: Jennifer Su, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm	Behavioral: Cardio-oncology rehabilitation; Least 60 minutes of physical activity each day including vigorous-intensity and strengthening activities at least 3 days per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cardiovascular fitness after completion of a 6-month exercise intervention.	Peak VO2% (exercise capacity) as measured by cardiopulmonary exercise testing.	Baseline to 6 months
Change in cardiovascular fitness after completion of a 6-month exercise intervention.	Ve/VCO2 slope (predictor of cardiac mortality) as measured by cardiopulmonary exercise testing.	Baseline to 6 months
Change in cardiovascular fitness after completion of a 6-month exercise intervention.	Chronotropic response (heart rate response to exercise) as measured by cardiopulmonary exercise testing.	Baseline to 6 months
Change in cardiovascular fitness after completion of a 6-month exercise intervention.	Blood pressure response to exercise as measured by cardiopulmonary exercise testing.	Baseline to 6 months
Change in cardiac function after completion of a 6-month exercise intervention.	Cardiac function will be assessed via echocardiogram.	Baseline to 6 months
Change in cardiac rhythm after completion of a 6-month exercise intervention.	Cardiac rhythm will be assessed via EKG.	Baseline to 6 months
Change in cardiac stress after completion of a 6-month exercise intervention.	Cardiac stress will be assessed via NT-proBNP level.	Baseline to 6 months
Average change in triglyceride level as measured from baseline to 6 months.	Triglyceride (mg/dL) will be measured.	Baseline to 6 months
Average change in total cholesterol level as measured from baseline to 6 months.	Total cholesterol (mg/dL) will be measured.	Baseline to 6 months
Average change in high density lipoprotein level as measured from baseline to 6 months.	High density lipoprotein (HDL) (mg/dL) will be measured.	Baseline to 6 months
Average change in low density lipoprotein as measured from baseline to 6 months.	Low density lipoprotein (LDL) (mg/dL) will be measured.	Baseline to 6 months
Average change in very low density lipoprotein as measured from baseline to 6 months.	Very low density lipoprotein (VLDL) (mg/dL) will be measured.	Baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average change in reported quality of life from baseline to 6 months	PedsQL(TM) Measurement Model will be used, which assesses physical, emotional, social, school functioning domains.	Baseline to 6 months
Percent of participants with improvement in healthy lifestyle habits from baseline to 6 months	Lifestyle habits will be assessed via exercise and dietary surveys completed by each participant.	Baseline to 6 months
Average change in activity level from baseline to 6 months	Activity levels will be assessed via exercise surveys as well as continuous FitBit(TM) activity data which will include weekly number of steps, average calorie burn, days of exercise, minute in activity, and average sleep time.	Baseline to 6 months

Collaborators and Investigators

• Sponsor: Children's Hospital Los Angeles
• Investigators: Principal Investigator: Jennifer Su, MD, Children's Hospital Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 31, 2025
• First Submitted That Met QC Criteria: February 12, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 12, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: physical activity; cardiac rehabilitation; cancer survivors; pediatric oncology; anthracycline exposure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: CHLA-22-00323

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No