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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how an at-home exercise program can improve heart health and overall well-being in young cancer survivors. It aims to determine if exercise and diet recommendations can boost cardiovascular fitness and general wellness. The trial seeks adolescent cancer survivors who are in remission and have been off chemotherapy for at least six months. Participants must be able to use a smartphone to track their activity and participate in monthly virtual check-ins. As an unphased trial, this study offers a unique opportunity for participants to contribute to research that could enhance recovery and quality of life for future cancer survivors.

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 prior data suggests that this at-home cardiac rehabilitation is safe for pediatric cancer survivors?

Earlier research has found cardio-oncology rehabilitation (a program combining heart health and cancer care) to be safe and manageable for patients. Participants in these programs reported better heart health and improved quality of life. Another study showed that these programs can help lower the risk of heart-related deaths and reduce hospital visits. No major reports of serious side effects have emerged, indicating general safety for participants. Overall, the evidence suggests these programs are beneficial and safe for cancer survivors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard cardiac rehabilitation programs that usually require regular visits to a medical facility, the at-home cardiac rehabilitation for heart failure is unique because it allows patients to engage in a personalized rehab program from the comfort of their own homes. This new approach is particularly exciting because it leverages technology to monitor patients remotely, ensuring they receive real-time feedback and support. Researchers are thrilled about this method as it can potentially increase patient adherence and accessibility, making cardiac rehab more inclusive for those with mobility or transportation challenges.

What evidence suggests that this at-home cardiac rehabilitation is effective for heart failure?

Research has shown that cardio-oncology rehabilitation (CORE), which participants in this trial will receive, can help cancer survivors enhance their heart health and quality of life. One study found that exercise-based heart rehab improved heart and lung fitness and increased survival rates. Reviews of multiple studies have found that these programs reduce heart-related deaths and hospital visits while improving overall life quality. This suggests that CORE could benefit young cancer survivors by enhancing their heart health and well-being. ^{1 2 3 4 5}

Who Is on the Research Team?

Jennifer Su, MD

Principal Investigator

Children's Hospital Los Angeles

Are You a Good Fit for This Trial?

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

Able to perform CPET

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12314747/

Cardio-oncology rehabilitation and exercise - PubMed Central The aim of this whitepaper is to review the current state of the literature on the effects of cardio-oncology rehabilitation and exercise (CORE) programmes ...

2. jamanetwork.com jamanetwork.com/journals/jamacardiology/fullarticle/2810101

Cardio-Oncology Rehabilitation for Cancer Survivors With ... Recent data from a large noncontrolled study showed that exercise-based CR was associated with improve cardiorespiratory fitness and survival in ...

3. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000000679

Cardio-Oncology Rehabilitation to Manage Cardiovascular ... Meta-analyses demonstrate that CR reduces CVD mortality and hospital admissions and improves health-related quality of life in patients with ...

4. jacc.org jacc.org/doi/10.1016/j.jaccao.2022.03.003

Research Quality and Impact of Cardiac Rehabilitation in ... The aim of this study was to evaluate the quality of reporting and evidence from CR-based intervention studies in oncology and to explore associations

5. sciencedirect.com sciencedirect.com/science/article/pii/S1443950623044554

Characteristics and Outcomes of Cardiac Rehabilitation ... This study aimed to compare characteristics and outcomes for patients participating in CR with and without an existing cancer diagnosis.