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

Not Applicable

Recruiting

• Conditions: Cardiovascular Complication; Chemotherapeutic Toxicity

• Registration Number: NCT06826534
• Lead Sponsor: Children's Hospital Los Angeles

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-20
• Study First Submitted: 2025-01-31
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-12
• Last Update Submitted: 2025-02-12
• Study First Posted: 2025-02-14
• Last Update Posted: 2025-02-14
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in cardiovascular fitness after completion of a 6-month exercise intervention.	Baseline to 6 months	Blood pressure response to exercise as measured by cardiopulmonary exercise testing.
Average change in total cholesterol level as measured from baseline to 6 months.	Baseline to 6 months	Total cholesterol (mg/dL) will be measured.
Change in cardiac function after completion of a 6-month exercise intervention.	Baseline to 6 months	Cardiac function will be assessed via echocardiogram.
Change in cardiac rhythm after completion of a 6-month exercise intervention.	Baseline to 6 months	Cardiac rhythm will be assessed via EKG.
Change in cardiac stress after completion of a 6-month exercise intervention.	Baseline to 6 months	Cardiac stress will be assessed via NT-proBNP level.
Average change in triglyceride level as measured from baseline to 6 months.	Baseline to 6 months	Triglyceride (mg/dL) will be measured.
Average change in very low density lipoprotein as measured from baseline to 6 months.	Baseline to 6 months	Very low density lipoprotein (VLDL) (mg/dL) will be measured.
Average change in high density lipoprotein level as measured from baseline to 6 months.	Baseline to 6 months	High density lipoprotein (HDL) (mg/dL) will be measured.
Average change in low density lipoprotein as measured from baseline to 6 months.	Baseline to 6 months	Low density lipoprotein (LDL) (mg/dL) will be measured.

Secondary Outcome Measures

Name	Time	Method
Average change in reported quality of life from baseline to 6 months	Baseline to 6 months	PedsQL(TM) Measurement Model will be used, which assesses physical, emotional, social, school functioning domains.
Percent of participants with improvement in healthy lifestyle habits from baseline to 6 months	Baseline to 6 months	Lifestyle habits will be assessed via exercise and dietary surveys completed by each participant.
Average change in activity level from baseline to 6 months	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.

Trial Locations

Locations (1)

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States