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Recruiting NCT06826534

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

No phase Interventional Cardiovascular Complication Chemotherapeutic Toxicity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cardio-oncology rehabilitation.
Who it may be relevant to
Registry conditions: Cardiovascular Complication, Chemotherapeutic Toxicity. Basic parameters: 0 years — 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Change in cardiovascular fitness after completion of a 6-month exercise intervention. [Time frame: Baseline to 6 months]
  • Change in cardiovascular fitness after completion of a 6-month exercise intervention. [Time frame: Baseline to 6 months]
  • Change in cardiovascular fitness after completion of a 6-month exercise intervention. [Time frame: Baseline to 6 months]
  • Change in cardiovascular fitness after completion of a 6-month exercise intervention. [Time frame: Baseline to 6 months]
  • Change in cardiac function after completion of a 6-month exercise intervention. [Time frame: Baseline to 6 months]
  • Change in cardiac rhythm after completion of a 6-month exercise intervention. [Time frame: Baseline to 6 months]
  • Change in cardiac stress after completion of a 6-month exercise intervention. [Time frame: Baseline to 6 months]
  • Average change in triglyceride level as measured from baseline to 6 months. [Time frame: Baseline to 6 months]
  • Average change in total cholesterol level as measured from baseline to 6 months. [Time frame: Baseline to 6 months]
  • Average change in high density lipoprotein level as measured from baseline to 6 months. [Time frame: Baseline to 6 months]
Secondary outcome measures (3)
  • Average change in reported quality of life from baseline to 6 months [Time frame: Baseline to 6 months]
  • Percent of participants with improvement in healthy lifestyle habits from baseline to 6 months [Time frame: Baseline to 6 months]
  • Average change in activity level from baseline to 6 months [Time frame: Baseline to 6 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Children's Hospital Los Angeles — Los Angeles

Identifiers

NCT: NCT06826534 · CHLA-22-00323

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗