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

February 12, 2025 updated by: Jennifer Su, Children's Hospital Los Angeles

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Children's Hospital Los Angeles
        • Contact:
        • Contact:
        • Contact:
          • Jennifer Su, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
Time Frame: Baseline to 6 months
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.
Time Frame: Baseline to 6 months
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.
Time Frame: Baseline to 6 months
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.
Time Frame: Baseline to 6 months
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.
Time Frame: Baseline to 6 months
Cardiac function will be assessed via echocardiogram.
Baseline to 6 months
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.
Baseline to 6 months
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.
Baseline to 6 months
Average change in triglyceride level as measured from baseline to 6 months.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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
Time Frame: 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
Time Frame: 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
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.
Baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Los Angeles

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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