At-Home Cardiac Rehabilitation for Adolescents at Risk for Heart Failure
NCT ID: NCT06826534
Last Updated: 2025-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2023-10-20
2025-12-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Arm
Cardio-oncology rehabilitation
Least 60 minutes of physical activity each day including vigorous-intensity and strengthening activities at least 3 days per week
Interventions
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Cardio-oncology rehabilitation
Least 60 minutes of physical activity each day including vigorous-intensity and strengthening activities at least 3 days per week
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
0 Years
21 Years
ALL
No
Sponsors
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Children's Hospital Los Angeles
OTHER
Responsible Party
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Jennifer Su
Assistant Professor, Keck School of Medicine, University of Southern California
Principal Investigators
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Jennifer Su, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Los Angeles
Locations
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Children's Hospital Los Angeles
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CHLA-22-00323
Identifier Type: -
Identifier Source: org_study_id
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