Recruiting

Cardiac Rehabilitation

Sponsor:

Children's Hospital Los Angeles

Code:

NCT06826534

Conditions

Cardiovascular Complication

Chemotherapeutic Toxicity

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Interventions

Cardio-oncology rehabilitation

Study Details

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.

Conditions

Cardiovascular Complication

Chemotherapeutic Toxicity

Study ID

NCT06826534

Start date

Oct 20, 2023

Status verified date

Feb, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Arm

Interventions

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 measure

  • 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 ]
  • Average change in low density lipoprotein as measured from baseline to 6 months. [ Time Frame: Baseline to 6 months ]
  • Average change in very low density lipoprotein as measured from baseline to 6 months. [ Time Frame: Baseline to 6 months ]

Central Contacts and Locations

Central contacts

Obdulio Carreras

(323) 361-4663ocarreras@chla.usc.edu

Jennifer Su, MD

(323) 361-5136jsu@chla.usc.edu

Locations

Children's Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Obdulio Carreras

(323) 361-4663ocarreras@chla.usc.edu

Jennifer Su, MD

(323) 361-5136jsu@chla.usc.edu

Principal Investigator:

Jennifer Su, MD

More Information

Sponsor

Children's Hospital Los Angeles

Last update posted

Feb 14, 2025

Last verified

Feb, 2025

Keywords

  • anthracycline exposure
  • cancer survivors
  • physical activity
  • pediatric oncology
  • cardiac rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Children's Hospital Los Angeles on 2025-02-14.