Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06826534 | RECRUITING | Cardiovascular Complication

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

Children's Hospital Los Angeles

Information provided by (Responsible Party):

Jennifer su

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.

Condition or disease

Cardiovascular Complication

Chemotherapeutic Toxicity

Intervention/treatment

Cardio-oncology rehabilitation

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 20 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : At-Home Cardiac Rehabilitation for Adolescents at Risk for Heart Failure
Actual Study Start Date : 2023-10-20
Estimated Primary Completion Date : 2025-12-31
Estimated Study Completion Date : 2025-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 0 Years to 21 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
    • At-Home Cardiac Rehabilitation for Adolescents at Risk for Heart Failure

    Location Details

    NCT06826534

    Please Choose a site

    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    RECRUITING

    United States, California

    Children's Hospital Los Angeles

    Los Angeles, California, United States, 90027