At-Home Cardiac Rehabilitation for Heart Failure

Overseen By Jennifer Su, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Los Angeles

Must not be taking: Beta blockers

Disqualifiers: Down syndrome, Congenital heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 6 months

20 Participants Needed

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude participants who are on beta blockers. If you are taking beta blockers, you may need to stop them to participate.

What data supports the effectiveness of the treatment Cardio-oncology Rehabilitation for heart failure?

Research shows that exercise therapy, a key part of cardio-oncology rehabilitation, improves heart and lung fitness and reduces negative heart effects from cancer treatments. Additionally, home-based cardiac rehabilitation has been found to enhance quality of life and lower hospital visits for heart failure patients. ^{1 2 3 4 5}

Is at-home cardiac rehabilitation safe for humans?

Exercise therapy, which is a key part of cardiac rehabilitation, is generally safe and well-tolerated in humans, including those with heart disease and cancer. It can improve fitness and counteract some negative effects of treatments, making it a promising option for people with heart failure or cancer-related heart issues. ^{1 3 6 7 8}

How does the Cardio-oncology Rehabilitation treatment for heart failure differ from other treatments?

Cardio-oncology Rehabilitation is unique because it integrates telehealth and mobile technologies to provide cardiac rehabilitation at home, which can overcome barriers like low utilization and pandemic restrictions. This approach is particularly beneficial for cancer patients and survivors who are at increased risk of cardiovascular issues due to cancer treatments. ^{1 2 9 10 11}

Research Team

Jennifer Su, MD

Principal Investigator

Children's Hospital Los Angeles

Eligibility Criteria

This trial is for adolescent cancer survivors at risk of heart failure. Participants should be able to follow an at-home cardio-oncology rehabilitation program and complete cardiovascular studies and quality-of-life surveys before and after the 6-month study.

Inclusion Criteria

I have been in remission and off chemotherapy for at least 6 months.

Able to perform CPET

My exercise test shows my oxygen use is less than 80% of expected.

Exclusion Criteria

Unable to check-in monthly on virtual platform

I am unable to give consent for medical procedures.

Unable to accurately perform quality of life survey independently

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo cardiovascular studies and a quality-of-life survey prior to exercise intervention

1 week

1 visit (in-person)

Treatment

Participants engage in a 6-month at-home cardio-oncology rehabilitation (CORE) program to improve cardiovascular fitness and psychosocial wellness

6 months

Regular virtual check-ins

Follow-up

Participants are monitored for changes in cardiac function, rhythm, stress, and lipid levels, as well as quality of life and lifestyle habits

4 weeks

Treatment Details

Interventions

• Cardio-oncology Rehabilitation

Trial Overview The trial tests an at-home cardio-oncology rehabilitation (CORE) program's effect on cardiovascular fitness and psychosocial well-being in adolescents. It will measure exercise adherence, identify valuable CORE resources, and assess lifestyle changes' impact on health.

Participant Groups

Group I: Treatment Arm Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Children's Hospital Los Angeles

Lead Sponsor

Trials

257

Recruited

5,075,000+

Findings from Research

Women with breast cancer and treatment-related heart failure showed significant improvements in peak aerobic power (VO2peak) after cardiac rehabilitation, similar to age-matched women with coronary artery disease, indicating the efficacy of rehabilitation for both groups.

Completion rates for the cardiac rehabilitation program were comparable between women with breast cancer and those with coronary artery disease, suggesting that cardiac rehabilitation is equally accessible and beneficial for these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation for women with breast cancer and treatment-related heart failure compared with coronary artery disease: A retrospective study. Bonsignore, A., Marzolini, S., Oh, P.[2018]

The field of cardio-oncology is emerging to address the cardiovascular health impacts of cancer treatments, which can have harmful effects on major organ systems, particularly the heart.

There is a need for better integration of cardio-oncology rehabilitation with overall cancer rehabilitation to support patients' health throughout their cancer journey, as current guidelines do not clearly define how to navigate this integration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardio-oncology and Cancer Rehabilitation: Is an Integrated Approach Possible? Pituskin, E., Foulkes, SJ., Cox-Kennett, N., et al.[2023]

Exercise therapy significantly improves cardiorespiratory fitness in cancer patients and helps reduce the cardiotoxic effects of cancer treatments, making it a crucial part of cardiac rehabilitation programs.

Starting exercise early after a cancer diagnosis and continuing throughout survivorship is generally safe and beneficial for heart health in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Training for Cancer Survivors. Tong, CKW., Lau, B., Davis, MK.[2021]

Home-based cardiac rehabilitation (CR) for heart failure significantly improves exercise capacity (VO2max) and health-related quality of life compared to usual medical care, with no increase in mortality or hospitalization risk.

The effectiveness and safety of home-based CR are comparable to centre-based CR, with higher completion rates in home-based programs, making it a viable alternative for heart failure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based cardiac rehabilitation for people with heart failure: A systematic review and meta-analysis. Zwisler, AD., Norton, RJ., Dean, SG., et al.[2022]

The REACH-HF intervention, a home-based cardiac rehabilitation program, significantly improved health-related quality of life in heart failure patients after 12 months, with a notable difference of -5.7 points on the Minnesota Living with Heart Failure questionnaire compared to usual care.

This study, involving 216 participants with heart failure and reduced ejection fraction, suggests that REACH-HF is a cost-effective alternative to traditional rehabilitation programs, potentially increasing participation rates in cardiac rehabilitation for heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects and costs of home-based rehabilitation for heart failure with reduced ejection fraction: The REACH-HF multicentre randomized controlled trial. Dalal, HM., Taylor, RS., Jolly, K., et al.[2022]

Cardiotoxicity from anti-cancer drugs is a significant concern, contributing to over 40% of cancer deaths, and is linked to mechanisms like DNA damage and oxidative stress.

Exercise training is safe and well-tolerated in cancer patients, leading to a 10-15% improvement in cardiorespiratory fitness, and may help counteract the adverse cardiovascular effects of cancer therapies, making tailored cardiac rehabilitation programs a promising option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardio-Oncology Rehabilitation-Present and Future Perspectives. Elad, B., Habib, M., Caspi, O.[2022]

A pilot exercise intervention for cancer survivors with chemotherapy-induced heart failure showed significant improvements in maximum oxygen uptake (O2max), indicating enhanced cardiovascular fitness.

The study demonstrated high satisfaction and adherence rates among participants, with no serious adverse events reported, suggesting that exercise rehabilitation is a safe and feasible option for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Outcomes of an Exercise Intervention for Chemotherapy-Induced Heart Failure. Tsai, E., Mouhayar, E., Lenihan, D., et al.[2023]

Cancer patients, especially those with early-stage disease, face a higher risk of cardiovascular disease due to both cancer treatments and lifestyle factors, highlighting the need for effective risk mitigation strategies.

The American Heart Association advocates for a multimodal approach, specifically cardiac rehabilitation, to support cancer patients by providing structured exercise and addressing unique cardiac risks associated with cancer therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardio-Oncology Rehabilitation to Manage Cardiovascular Outcomes in Cancer Patients and Survivors: A Scientific Statement From the American Heart Association. Gilchrist, SC., Barac, A., Ades, PA., et al.[2020]

Patients with heart failure (HF) who completed home-based cardiac rehabilitation (HBCR) had a significantly lower risk of all-cause mortality and hospitalizations compared to those who did not attend HBCR, with an adjusted hazard ratio of 0.32.

Both heart failure with reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF) patients showed similar improvements in health outcomes after completing HBCR, making it a beneficial option for those unable to attend traditional center-based rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home Based Cardiac Rehabilitation Participation Among Patients With Heart Failure. Hammad Jafri, S., Qureshi, R., Ho, TTT., et al.[2023]

Cancer treatments can lead to increased cardiovascular risks, making it important to implement comprehensive cardiac rehabilitation, known as cardio-oncology rehabilitation, to help mitigate these risks.

Telehealth and mobile applications show promise as effective alternatives for delivering cardio-oncology rehabilitation, providing both physiological and psychological benefits to cancer patients and survivors, especially during barriers like the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardio-Oncology Rehabilitation and Telehealth: Rationale for Future Integration in Supportive Care of Cancer Survivors. Batalik, L., Filakova, K., Radkovcova, I., et al.[2022]

Home-based cardiac rehabilitation significantly improved exercise capacity and quality of life in heart failure patients, with a 14.2% increase in peak oxygen uptake and a 37% increase in quality of life scores over a 3-month period.

The program also led to a reduction in the 90-day hospital readmission rate from 14% to 5%, highlighting its effectiveness in managing chronic heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based cardiac rehabilitation improves quality of life, aerobic capacity, and readmission rates in patients with chronic heart failure. Chen, YW., Wang, CY., Lai, YH., et al.[2018]

References

1. Sweden pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation for women with breast cancer and treatment-related heart failure compared with coronary artery disease: A retrospective study. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Cardio-oncology and Cancer Rehabilitation: Is an Integrated Approach Possible? [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Exercise Training for Cancer Survivors. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Home-based cardiac rehabilitation for people with heart failure: A systematic review and meta-analysis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The effects and costs of home-based rehabilitation for heart failure with reduced ejection fraction: The REACH-HF multicentre randomized controlled trial. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Cardio-Oncology Rehabilitation-Present and Future Perspectives. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Feasibility and Outcomes of an Exercise Intervention for Chemotherapy-Induced Heart Failure. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Cardio-Oncology Rehabilitation to Manage Cardiovascular Outcomes in Cancer Patients and Survivors: A Scientific Statement From the American Heart Association. [2020]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Home Based Cardiac Rehabilitation Participation Among Patients With Heart Failure. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Cardio-Oncology Rehabilitation and Telehealth: Rationale for Future Integration in Supportive Care of Cancer Survivors. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Home-based cardiac rehabilitation improves quality of life, aerobic capacity, and readmission rates in patients with chronic heart failure. [2018]