Clinical trial · Interventional
At-Home Cardiac Rehabilitation for Adolescents at Risk for Heart Failure
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cardiovascular Complication | — | UNRESOLVED | — |
| Chemotherapeutic Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cardio-oncology rehabilitation | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment Arm
- interventionNames
- Behavioral: Cardio-oncology rehabilitation
Primary outcomes (12)
- measure
- Change in cardiovascular fitness after completion of a 6-month exercise intervention.
- timeFrame
- Baseline to 6 months
- description
- Peak VO2% (exercise capacity) as measured by cardiopulmonary exercise testing.
- measure
- Change in cardiovascular fitness after completion of a 6-month exercise intervention.
- timeFrame
- Baseline to 6 months
- description
- Ve/VCO2 slope (predictor of cardiac mortality) as measured by cardiopulmonary exercise testing.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
- Maximum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available