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NCT Number: NCT06826534

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.

Recruiting

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Key information

Conditions

Cardiovascular Complication Behavior Chemotherapeutic Toxicity Motor Activity

Age range

0 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardio-oncology rehabilitation

Behavioral

Least 60 minutes of physical activity each day including vigorous-intensity and strengthening activities at least 3 days per week

Primary outcomes

  1. Change in cardiovascular fitness after completion of a 6-month exercise intervention.

    Time frame: Baseline to 6 months

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

  2. Change in cardiovascular fitness after completion of a 6-month exercise intervention.

    Time frame: Baseline to 6 months

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

  3. Change in cardiovascular fitness after completion of a 6-month exercise intervention.

    Time frame: Baseline to 6 months

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

  4. Change in cardiovascular fitness after completion of a 6-month exercise intervention.

    Time frame: Baseline to 6 months

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

  5. Change in cardiac function after completion of a 6-month exercise intervention.

    Time frame: Baseline to 6 months

    Cardiac function will be assessed via echocardiogram.

  6. Change in cardiac rhythm after completion of a 6-month exercise intervention.

    Time frame: Baseline to 6 months

    Cardiac rhythm will be assessed via EKG.

  7. Change in cardiac stress after completion of a 6-month exercise intervention.

    Time frame: Baseline to 6 months

    Cardiac stress will be assessed via NT-proBNP level.

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

    Time frame: Baseline to 6 months

    Triglyceride (mg/dL) will be measured.

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

    Time frame: Baseline to 6 months

    Total cholesterol (mg/dL) will be measured.

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

    Time frame: Baseline to 6 months

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

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

    Time frame: Baseline to 6 months

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

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

    Time frame: Baseline to 6 months

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

Secondary outcomes

  1. Average change in reported quality of life from baseline to 6 months

    Time frame: Baseline to 6 months

    PedsQL(TM) Measurement Model will be used, which assesses physical, emotional, social, school functioning domains.

  2. Percent of participants with improvement in healthy lifestyle habits from baseline to 6 months

    Time frame: Baseline to 6 months

    Lifestyle habits will be assessed via exercise and dietary surveys completed by each participant.

  3. Average change in activity level from baseline to 6 months

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Su, MD

CONTACT

[email protected]

(323) 361-5136

Obdulio Carreras

CONTACT

[email protected]

(323) 361-4663

Sponsors and collaborators

Lead sponsor

Children's Hospital Los Angeles

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 14, 2025
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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