At-Home Cardiac Rehabilitation for Adolescents at Risk for Heart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-21
SponsorChildren's Hospital Los Angeles
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Cardio-oncology rehabilitation
BehavioralLeast 60 minutes of physical activity each day including vigorous-intensity and strengthening activities at least 3 days per week
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Treatment ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in cardiovascular fitness after completion of a 6-month exercise intervention.
Peak VO2% (exercise capacity) as measured by cardiopulmonary exercise testing.
Time frame
Baseline to 6 months2
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.
Time frame
Baseline to 6 months3
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.
Time frame
Baseline to 6 months4
Change in cardiovascular fitness after completion of a 6-month exercise intervention.
Blood pressure response to exercise as measured by cardiopulmonary exercise testing.
Time frame
Baseline to 6 monthsSecondary outcomes
1
Average change in reported quality of life from baseline to 6 months
PedsQL(TM) Measurement Model will be used, which assesses physical, emotional, social, school functioning domains.
Time frame
Baseline to 6 months2
Percent of participants with improvement in healthy lifestyle habits from baseline to 6 months
Lifestyle habits will be assessed via exercise and dietary surveys completed by each participant.
Time frame
Baseline to 6 months3
Average change in activity level from 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.
Time frame
Baseline to 6 monthsSponsors and contacts
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Source ClinicalTrials.gov