Cardiovascular ComplicationNCT06826534
At-Home Cardiac Rehabilitation for Adolescents at Risk for Heart Failure
A study testing Cardio-oncology rehabilitation in people with Cardiovascular Complication and Chemotherapeutic Toxicity, run by Children's Hospital Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 21 years
- Conditions the study is for
- Cardiovascular Complication, Chemotherapeutic Toxicity
- What is being tested?
- Cardio-oncology rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027
Obdulio Carreras, (323) 361-4663, ocarreras@chla.usc.edu
Jennifer Su, MD, (323) 361-5136, jsu@chla.usc.edu
About this study
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.
- Being tested
- Cardio-oncology rehabilitation
- Keywords
- anthracycline exposure, cancer survivors, physical activity, pediatric oncology, cardiac rehabilitation
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardio-oncology rehabilitationBehavioural
Least 60 minutes of physical activity each day including vigorous-intensity and strengthening activities at least 3 days per week
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Not described Receives: Behavioral: Cardio-oncology rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardiovascular fitness after completion of a 6-month exercise intervention.
Peak VO2% (exercise capacity) as measured by cardiopulmonary exercise testing.
Measured: Baseline to 6 months
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.
Measured: Baseline to 6 months
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.
Measured: Baseline to 6 months
Change in cardiovascular fitness after completion of a 6-month exercise intervention.
Blood pressure response to exercise as measured by cardiopulmonary exercise testing.
Measured: Baseline to 6 months
Change in cardiac function after completion of a 6-month exercise intervention.
Cardiac function will be assessed via echocardiogram.
Measured: Baseline to 6 months
Change in cardiac rhythm after completion of a 6-month exercise intervention.
Cardiac rhythm will be assessed via EKG.
Measured: Baseline to 6 months
Change in cardiac stress after completion of a 6-month exercise intervention.
Cardiac stress will be assessed via NT-proBNP level.
Measured: Baseline to 6 months
Average change in triglyceride level as measured from baseline to 6 months.
Triglyceride (mg/dL) will be measured.
Measured: Baseline to 6 months
Average change in total cholesterol level as measured from baseline to 6 months.
Total cholesterol (mg/dL) will be measured.
Measured: Baseline to 6 months
Average change in high density lipoprotein level as measured from baseline to 6 months.
High density lipoprotein (HDL) (mg/dL) will be measured.
Measured: Baseline to 6 months
Average change in low density lipoprotein as measured from baseline to 6 months.
Low density lipoprotein (LDL) (mg/dL) will be measured.
Measured: Baseline to 6 months
Average change in very low density lipoprotein as measured from baseline to 6 months.
Very low density lipoprotein (VLDL) (mg/dL) will be measured.
Measured: Baseline to 6 months
Secondary outcomes (3)
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.
Measured: Baseline to 6 months
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.
Measured: Baseline to 6 months
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.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start20 Oct 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular ComplicationStudies of the same condition, open and under way.
- More trials run by Children's Hospital Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Su, Children's Hospital Los Angeles
- Investigators
- Jennifer Su, MD, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826534
- Sponsor's protocol ID
- CHLA-22-00323
- Status last verified
- Feb 2025
- First submitted
- 31 Jan 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- At-Home Cardiac Rehabilitation for Adolescents at Risk for Heart Failure
- ClinicalTrials.gov ID
- NCT06826534
- Acronym / sponsor ID
- CHLA-22-00323
- Keywords
- anthracycline exposure, cancer survivors, physical activity, pediatric oncology, cardiac rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Behavioral: Cardio-oncology rehabilitation |
Who may qualify
- Ages
- 0 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardio-oncology rehabilitationLeast 60 minutes of physical activity each day including vigorous-intensity and strengthening activities at least 3 days per week | Behavioural | Treatment Arm |
Primary outcome
Change in cardiovascular fitness after completion of a 6-month exercise intervention.
Time frame: Baseline to 6 months
Peak VO2% (exercise capacity) as measured by cardiopulmonary exercise testing.
Change in cardiovascular fitness after completion of a 6-month exercise intervention.
Time frame: Baseline to 6 months
Ve/VCO2 slope (predictor of cardiac mortality) as measured by cardiopulmonary exercise testing.
Change in cardiovascular fitness after completion of a 6-month exercise intervention.
Time frame: Baseline to 6 months
Chronotropic response (heart rate response to exercise) as measured by cardiopulmonary exercise testing.
Change in cardiovascular fitness after completion of a 6-month exercise intervention.
Time frame: Baseline to 6 months
Blood pressure response to exercise as measured by cardiopulmonary exercise testing.
Change in cardiac function after completion of a 6-month exercise intervention.
Time frame: Baseline to 6 months
Cardiac function will be assessed via echocardiogram.
Change in cardiac rhythm after completion of a 6-month exercise intervention.
Time frame: Baseline to 6 months
Cardiac rhythm will be assessed via EKG.
Change in cardiac stress after completion of a 6-month exercise intervention.
Time frame: 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.
Time frame: Baseline to 6 months
Triglyceride (mg/dL) will be measured.
Average change in total cholesterol level as measured from baseline to 6 months.
Time frame: Baseline to 6 months
Total cholesterol (mg/dL) will be measured.
Average change in high density lipoprotein level as measured from baseline to 6 months.
Time frame: 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.
Time frame: Baseline to 6 months
Low density lipoprotein (LDL) (mg/dL) will be measured.
Average change in very low density lipoprotein as measured from baseline to 6 months.
Time frame: Baseline to 6 months
Very low density lipoprotein (VLDL) (mg/dL) will be measured.
3 secondary outcomes
Average change in reported quality of life from baseline to 6 months
Time frame: Baseline to 6 months
Percent of participants with improvement in healthy lifestyle habits from baseline to 6 months
Time frame: Baseline to 6 months
Average change in activity level from baseline to 6 months
Time frame: Baseline to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Su, MD principal investigator
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardio-oncology rehabilitation in people with Cardiovascular Complication and Chemotherapeutic Toxicity, run by Children's Hospital Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Obdulio Carreras ((323) 361-4663, ocarreras@chla.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cardiovascular fitness after completion of a 6-month exercise intervention. (time frame: Baseline to 6 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.