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

This study is looking at how an at-home cardio-oncology rehabilitation (CORE) program can help adolescent cancer survivors who are at risk for heart failure. The program involves at least 60 minutes of physical activity each day, including vigorous exercise and strengthening activities at least three times a week. The goal is to see if this program improves your heart fitness and overall well-being. Researchers also want to understand how well participants stick to the exercise plan and what resources are most helpful. You may be able to join if you are between 10 and 21 years old, have a history of certain cancer treatments, are in remission, and meet specific heart fitness criteria. The study aims to measure changes in heart fitness after six months.

Study design
This is an interventional study planning to enroll 20 participants. The study is testing a behavioral intervention called cardio-oncology rehabilitation.
What's involved
You would participate in a 6-month exercise intervention, which includes at least 60 minutes of physical activity daily, with vigorous-intensity and strengthening activities at least 3 days per week.
Compensation
Not stated in the trial record.
Follow-up
Your cardiovascular fitness will be measured at the beginning of the study and again after 6 months.

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NCT06826534

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

Recruiting
NAAges 0–21InterventionalTreatment
Children's Hospital Los Angeles
~20 participants
Updated 2025-02-14 on ClinicalTrials.gov
What's tested:Cardio-oncology rehabilitation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in cardiovascular fitness after completion of a 6-month exercise intervention.
Measured over Baseline to 6 months
+11 more outcomes measured
Cardiovascular Complication
Chemotherapeutic Toxicity
1 sites across 1 states
California1
  • Jennifer Su, MD · PRINCIPAL_INVESTIGATOR · Children's Hospital Los Angeles

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Eligibility criteria

Inclusion

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

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
  • Change in cardiovascular fitness after completion of a 6-month exercise intervention.Baseline to 6 months

    Peak VO2% (exercise capacity) as measured by cardiopulmonary exercise testing.

  • Change in cardiovascular fitness after completion of a 6-month exercise intervention.Baseline to 6 months

    Ve/VCO2 slope (predictor of cardiac mortality) as measured by cardiopulmonary exercise testing.

  • Change in cardiovascular fitness after completion of a 6-month exercise intervention.Baseline to 6 months

    Chronotropic response (heart rate response to exercise) as measured by cardiopulmonary exercise testing.

  • Change in cardiovascular fitness after completion of a 6-month exercise intervention.Baseline to 6 months

    Blood pressure response to exercise as measured by cardiopulmonary exercise testing.

  • Change in cardiac function after completion of a 6-month exercise intervention.Baseline to 6 months

    Cardiac function will be assessed via echocardiogram.

  • Change in cardiac rhythm after completion of a 6-month exercise intervention.Baseline to 6 months

    Cardiac rhythm will be assessed via EKG.

  • Change in cardiac stress after completion of a 6-month exercise intervention.Baseline to 6 months

    Cardiac stress will be assessed via NT-proBNP level.

  • Average change in triglyceride level as measured from baseline to 6 months.Baseline to 6 months

    Triglyceride (mg/dL) will be measured.

  • Average change in total cholesterol level as measured from baseline to 6 months.Baseline to 6 months

    Total cholesterol (mg/dL) will be measured.

  • Average change in high density lipoprotein level as measured from baseline to 6 months.Baseline to 6 months

    High density lipoprotein (HDL) (mg/dL) will be measured.

  • Average change in low density lipoprotein as measured from baseline to 6 months.Baseline to 6 months

    Low density lipoprotein (LDL) (mg/dL) will be measured.

  • Average change in very low density lipoprotein as measured from baseline to 6 months.Baseline to 6 months

    Very low density lipoprotein (VLDL) (mg/dL) will be measured.