At-Home Cardiac Rehabilitation for Heart Failure
Recruiting in Palo Alto (17 mi)
Overseen ByJennifer Su, MD
Age: < 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Children's Hospital Los Angeles
No Placebo Group
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.
12345Is 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.
13678How 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.
1291011Eligibility 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
My exercise test shows my oxygen use is less than 80% of expected.
I am between 10 and 21 years old.
I have been treated with anthracyclines, with or without radiation.
Exclusion Criteria
I am unable to give consent for medical procedures.
I don't have major health conditions like Down Syndrome or a history of heart surgery.
I cannot undergo certain heart or lab tests.
I can't do light activities for 30 minutes, twice a week.
I cannot visit the hospital for study check-ups at the start and after 6 months.
I am currently taking beta blockers.
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment1 Intervention
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Children's Hospital Los AngelesLos Angeles, CA
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Who is running the clinical trial?
Children's Hospital Los AngelesLead Sponsor
References
Cardiac rehabilitation for women with breast cancer and treatment-related heart failure compared with coronary artery disease: A retrospective study. [2018]To examine clinical outcomes and completion rates of cardiac rehabilitation in women with breast cancer and treatment-related heart failure.
Cardio-oncology and Cancer Rehabilitation: Is an Integrated Approach Possible? [2023]With significant improvements in the understanding of cancer biology, improved detection, and the use of novel adjuvant therapies, each year more Canadians are surviving a cancer diagnosis. Despite their effectiveness these therapies often result in short- and long-term deleterious effects to major organ systems, particularly cardiovascular. Cardio-oncology is an emerging field of study with the aim to improve cardiovascular health across the oncology disease spectrum. International guidelines distinguish "cardio-oncology" rehabilitation from "cancer" rehabilitation, but how this is navigated is currently unknown. How such care should be assessed and integrated acutely or in the longer term remains unknown. Accordingly, the aim of this article is to consider the cancer patient's needs beyond the scope of cardio-oncology rehabilitation to holistically integrate cancer rehabilitation across the disease trajectory.
Exercise Training for Cancer Survivors. [2021]Cardiovascular diseases are a common cause of morbidity and mortality in cancer survivors. Furthermore, some cancer therapies are now being increasingly recognized to have negative cardiovascular effects, or cardiotoxicity. Exercise therapy has been found to improve cardiorespiratory fitness in patients with cancer as well as attenuate the cardiotoxic effects of cancer therapy. It is the centerpiece for cardiac and pulmonary rehabilitation programs. It is also an important component in cardio-oncology rehabilitation. Exercise is generally safe, and its benefit is observed when started as soon as the diagnosis of cancer and throughout cancer survivorship.
Home-based cardiac rehabilitation for people with heart failure: A systematic review and meta-analysis. [2022]To assess the effectiveness of home-based cardiac rehabilitation (CR) for heart failure compared to either usual medical care (i.e. no CR) or centre-based CR on mortality, morbidity, exercise capacity, health-related quality of life, drop out, adherence rates, and costs.
The effects and costs of home-based rehabilitation for heart failure with reduced ejection fraction: The REACH-HF multicentre randomized controlled trial. [2022]Cardiac rehabilitation improves health-related quality of life (HRQoL) and reduces hospitalizations in patients with heart failure, but international uptake of cardiac rehabilitation for heart failure remains low.
Cardio-Oncology Rehabilitation-Present and Future Perspectives. [2022]Recent advances in cancer therapy have led to increased survival rates for cancer patients, but also allowed cardiovascular complications to become increasingly evident, with more than 40% of cancer deaths now being attributed to cardiovascular diseases. Cardiotoxicity is the most concerning cardiovascular complication, one caused mainly due to anti-cancer drugs. Among the harmful mechanisms of these drugs are DNA damage, endothelial dysfunction, and oxidative stress. Cancer patients can suffer reduced cardiorespiratory fitness as a secondary effect of anti-cancer therapies, tumor burden, and deconditioning. In the general population, regular exercise can reduce the risk of cardiovascular morbidity, mortality, and cancer. Exercise-induced modifications of gene expression result in improvements of cardiovascular parameters and an increased general fitness, influencing telomere shortening, oxidative stress, vascular function, and DNA repair mechanisms. In cancer patients, exercise training is generally safe and well-tolerated; it is associated with a 10-15% improvement in cardiorespiratory fitness and can potentially counteract the adverse effects of anti-cancer therapy. It is well known that exercise programs can benefit patients with heart disease and cancer, but little research has been conducted with cardio-oncology patients. To date, there are a limited number of effective protective treatments for preventing or reversing cardiotoxicity caused by cancer therapy. Cardiac rehabilitation has the potential to mitigate cardiotoxicity based on the benefits already proven in populations suffering from either cancer or heart diseases. Additionally, the fact that cardiotoxic harm mechanisms coincide with similar mechanisms positively affected by cardiac rehabilitation makes cardiac rehabilitation an even more plausible option for cardio-oncology patients. Due to unstable functional capacity and fluctuating immunocompetence, these patients require specially tailored exercise programs designed collaboratively by cardiologists and oncologists. As the digital era is here, with the digital world and the medical world continuously intertwining, a remote, home-based cardio-oncology rehabilitation program may be a solution for this population.
Feasibility and Outcomes of an Exercise Intervention for Chemotherapy-Induced Heart Failure. [2023]Cancer treatment-related heart failure (HF) is an emerging health concern, as the number of survivors is increasing rapidly, and cardiac health issues are a leading cause of mortality in this population. While there is general evidence for the efficacy of exercise rehabilitation interventions, more research is needed on exercise rehabilitation interventions for patients specifically with treatment-induced HF and whether such interventions are safe and well-accepted. This study provides feasibility and health outcomes of a pilot exercise intervention for cancer survivors with chemotherapy-induced HF.
Cardio-Oncology Rehabilitation to Manage Cardiovascular Outcomes in Cancer Patients and Survivors: A Scientific Statement From the American Heart Association. [2020]Cardiovascular disease is a competing cause of death in patients with cancer with early-stage disease. This elevated cardiovascular disease risk is thought to derive from both the direct effects of cancer therapies and the accumulation of risk factors such as hypertension, weight gain, cigarette smoking, and loss of cardiorespiratory fitness. Effective and viable strategies are needed to mitigate cardiovascular disease risk in this population; a multimodal model such as cardiac rehabilitation may be a potential solution. This statement from the American Heart Association provides an overview of the existing knowledge and rationale for the use of cardiac rehabilitation to provide structured exercise and ancillary services to cancer patients and survivors. This document introduces the concept of cardio-oncology rehabilitation, which includes identification of patients with cancer at high risk for cardiac dysfunction and a description of the cardiac rehabilitation infrastructure needed to address the unique exposures and complications related to cancer care. In this statement, we also discuss the need for future research to fully implement a multimodal model of cardiac rehabilitation for patients with cancer and to determine whether reimbursement of these services is clinically warranted.
Home Based Cardiac Rehabilitation Participation Among Patients With Heart Failure. [2023]Patients with Heart Failure (HF) have significant morbidity and mortality. Home Based Cardiac Rehabilitation (HBCR) is a form of Cardiac Rehabilitation (CR) which has been proven beneficial for the patients with cardiovascular disease; However, cardiovascular outcomes in patients with HF who was referred to HBCR is not known.
Cardio-Oncology Rehabilitation and Telehealth: Rationale for Future Integration in Supportive Care of Cancer Survivors. [2022]The direct toxicity of cancer treatment threatens patients and survivors with an increased risk of cardiovascular disease or adverse functional changes with subsequent progression of cardiovascular complications. An accumulation of cardiovascular risk factors combined with an unhealthy lifestyle has recently become more common in cancer patients and survivors. It has been recommended to integrate a comprehensive cardiac rehabilitation model called cardio-oncology rehabilitation to mitigate cardiovascular risk. Nevertheless, cardiac rehabilitation interventions limit barriers in low utilization, further exacerbated by the restrictions associated with the COVID-19 pandemic. Therefore, it is essential to integrate alternative interventions such as telehealth, which can overcome several barriers. This literature review was designed as a framework for developing and evaluating telehealth interventions and mobile applications for comprehensive cardio-oncology rehabilitation. We identify knowledge gaps and propose strategies to facilitate the development and integration of cardio-oncology rehabilitation telehealth as an alternative approach to the standard of care for cancer patients and survivors. Despite the limited evidence, the pilot results from included studies support the feasibility and acceptability of telehealth and mobile technologies in cardio-oncology rehabilitation. This new area suggests that telehealth interventions are feasible and induce physiological and psychological benefits for cancer patients and survivors. There is an assumption that telehealth interventions and exercise may be an effective future alternative approach in supportive cancer care.
Home-based cardiac rehabilitation improves quality of life, aerobic capacity, and readmission rates in patients with chronic heart failure. [2018]Exercise tolerance and cardiac output have a major impact on the quality of life (QOL) of patients experiencing heart failure (HF). Home-based cardiac rehabilitation can significantly improve not only exercise tolerance but also peak oxygen uptake ((Equation is included in full-text article.)peak), and the QOL in patients with HF. The aim of this prospective study was to evaluate the beneficial effects of home-based cardiac rehabilitation on the quality of medical care in patients with chronic HF.