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

NCT06826534 | Recruiting

• 1 other identifier: CHLA-22-00323
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (12)

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

  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.

  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.

  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.

  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.

  Cardiac function will be assessed via echocardiogram.

  Baseline to 6 months

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

  Cardiac rhythm will be assessed via EKG.

  Baseline to 6 months

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

  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.

  Triglyceride (mg/dL) will be measured.

  Baseline to 6 months

• Average change in total cholesterol level as measured from 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.

  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.

  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.

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

  Baseline to 6 months

Secondary Outcomes (3)

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

  Baseline to 6 months

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

  Baseline to 6 months

• Average change in activity level from baseline to 6 months

  Baseline to 6 months

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Behavioral: Cardio-oncology rehabilitation

Interventions

Cardio-oncology rehabilitation BEHAVIORAL

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

Treatment Arm

Eligibility Criteria

• Age: 0 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Jennifer Su, MD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Obdulio Carreras

CONTACT

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

Jennifer Su, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Keck School of Medicine, University of Southern California

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 14, 2025
• Study Start: October 20, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)