NCT06826534Recruiting
At-Home Cardiac Rehabilitation for Adolescents at Risk for Heart Failure
Source: ClinicalTrials.gov · Last updated 14 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 31 Jan 2025
- Start date
- 20 Oct 2023
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Children's Hospital Los Angeles
- Diseases
- Heart failure, Childhood cancers
- NCT number
- NCT06826534
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 20 Oct 2023 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Lab values
- Unable to perform CPET, echocardiogram, EKG, or obtain laboratory studies
Other
- Inability to obtain consent/assent
- Unable to accurately perform quality of life survey independently
- 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
Who the study is looking for
- 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
Age in the registry: 0 years to 21 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Hospital Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.