Home Exercise Program for Heart Condition

Overseen By Blake Armstrong

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must not be taking: Intravenous inotropes

Disqualifiers: Pregnancy, Severe ventricular dysfunction, others

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

Compensation: Varies

Number of Visits: 2

53 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a home exercise program to determine its effectiveness for individuals with Fontan physiology, a specific heart condition. The goal is to enhance physical strength and endurance while assessing potential benefits for liver issues associated with the condition. Additionally, the trial evaluates whether a remote exercise program can improve access to exercise without requiring travel. Suitable participants are those with Fontan physiology who face related challenges.

As an unphased trial, this study provides participants the chance to contribute to innovative research that could enhance the quality of life for those with Fontan physiology.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on intravenous inotropic drugs (medications that help the heart pump more effectively).

What prior data suggests that this home exercise program is safe for individuals with Fontan heart physiology?

Research has shown that home exercise programs, especially those using telemedicine, are generally safe for people with heart conditions. One study demonstrated that a similar program for patients with heart issues was well-tolerated over six weeks, with participants reporting no major problems.

Another study examined a digital home-based cardiac rehab program and found it practical and safe. Participants completed exercises at home with digital guidance and support.

Since this trial is not in the early stages, the safety of these home exercise programs is well-established. Overall, these programs are designed to be convenient and safe, enabling people to exercise at home with professional guidance. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this home exercise program for heart conditions because it offers a potential alternative to traditional treatments like medication and surgery. Unlike these standard options, the home exercise program empowers patients to manage their heart health actively and independently from their homes. This approach not only aims to improve heart function but also enhances overall quality of life by promoting a sustainable and accessible lifestyle change. The focus on exercise as a primary intervention could reduce the reliance on costly or invasive treatments, making it an appealing option for both patients and healthcare providers.

What evidence suggests that this home exercise program is effective for improving frailty and exercise capacity in individuals with Fontan heart physiology?

Research has shown that exercising at home benefits heart health. One study found that a 12-week home exercise program using telehealth increased activity levels and improved exercise capacity. This type of program is practical and easy to follow. Another study found that home-based cardiac rehab programs, incorporating two types of exercises, facilitate access to necessary care for individuals with heart conditions. Although limited data exists specifically for people with Fontan heart physiology, these findings suggest that structured home exercise, like the program tested in this trial, could enhance activity levels and improve health markers. ^{1 4 6 7 8}

Who Is on the Research Team?

Jesse Hansen, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for adults with Fontan heart physiology who can exercise and aren't on IV heart drugs. It's not for those with severe heart issues seen in recent echocardiograms, under 130 cm tall, pregnant or planning pregnancy during the study, or have noncardiac conditions that could affect participation.

Inclusion Criteria

I have undergone the Fontan procedure.

Exclusion Criteria

I am shorter than 130 cm.

Inability to complete exercise testing at baseline screening

Pregnancy or the plan to become pregnant during the study period

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete a cardiopulmonary exercise test (CPET), liver ultrasound, 6-minute walk, grip strength test, arm circumference measure, body composition analysis, anthropometrics measurement, surveys, and a biomarker blood sample collection

1 day

1 visit (in-person)

Home Exercise Program

Participants engage in a telemedicine-based structured home exercise program to reduce frailty and improve exercise capacity

26 weeks

Virtual follow-up visits

Final Assessment

Participants complete a final cardiopulmonary exercise test, liver ultrasound, 6-minute walk, grip strength test, arm circumference, biomarker blood sample, and final survey

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Home exercise program

Trial Overview The trial tests a home exercise program delivered via telemedicine to see if it improves frailty and exercise capacity in people with Fontan physiology. It also examines whether this approach overcomes barriers to access and affects liver disease markers associated with Fontan.

How Is the Trial Designed?

Group I: Home exercise program Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

A 12-week home-based cardiac exercise program (HBCEP) significantly improved exercise capacity, serum lipid levels, and self-efficacy in 30 coronary heart disease patients in Turkey, compared to a control group.

The improvements in health outcomes suggest that enhancing self-efficacy through educational sessions and goal-setting strategies may play a crucial role in helping patients adhere to exercise programs and reduce cardiac risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of home-based cardiac exercise program on the exercise tolerance, serum lipid values and self-efficacy of coronary patients. Senuzun, F., Fadiloglu, C., Burke, LE., et al.[2019]

A systematic review of 30 meta-analyses on cardiac rehabilitation (CR) showed that 60% of the analyzed outcomes, including mortality and exercise capacity, were statistically significant, indicating the effectiveness of supervised, home-based, or telemedicine-based CR for patients with coronary heart disease or heart failure.

While the statistical significance supports the promotion of CR programs, only 35% of the outcomes were deemed clinically important, suggesting that further research is needed to fully understand the practical benefits of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of recent cardiac rehabilitation meta-analyses in patients with coronary heart disease or heart failure. Oldridge, N., Pakosh, M., Grace, SL.[2020]

Exercise training (ET) is a powerful therapeutic tool for patients with coronary heart disease (CHD), showing significant benefits in cardiovascular health and overall mortality when implemented through cardiac rehabilitation (CR) programs.

Despite its effectiveness, CR remains under-utilized; innovations like high-intensity protocols and remote delivery options (home and tele-health CR) are emerging to enhance accessibility and efficacy, but more research is needed to establish their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training and cardiac rehabilitation in cardiovascular disease. Kachur, S., Lavie, CJ., Morera, R., et al.[2019]

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]

Regular exercise training is highly recommended for heart failure patients, supported by strong evidence, yet many patients remain inactive due to various barriers.

Home telerehabilitation is proposed as an effective solution to encourage physical activity among heart failure patients, addressing the limitations of traditional outpatient rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to do: telerehabilitation in heart failure patients. Piotrowicz, E.[2019]

A hospital-based exercise program significantly improved functional capacity and quality of life in heart transplant patients, as evidenced by increased maximal oxygen consumption and scores in most quality of life measures after 8 weeks.

In contrast, a home-based exercise program showed limited benefits, with only minor improvements in bodily pain, suggesting that structured, supervised exercise is more effective for recovery in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of hospital-supervised exercise versus home-based exercise in patients after orthotopic heart transplantation: effects on functional capacity, quality of life, and psychological symptoms. Karapolat, H., Eyigör, S., Zoghi, M., et al.[2007]

Home-based cardiac rehabilitation, using a nurse-facilitated self-help package over 6 weeks, was found to be slightly less expensive than traditional hospital-based rehabilitation, primarily due to lower personnel costs.

Both home-based and hospital-based rehabilitation showed similar overall healthcare costs and quality of life outcomes over 9 months, indicating that home-based programs can be a cost-effective alternative without compromising patient health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based cardiac rehabilitation versus hospital-based rehabilitation: a cost effectiveness analysis. Taylor, RS., Watt, A., Dalal, HM., et al.[2022]

A global survey revealed that cardiac rehabilitation (CR) is available in 54.7% of countries, with 76.6% offering supervised programs and 45.9% providing alternative models like home-based or community-based programs.

Home-based CR programs are underutilized, serving only 21.4% of patients on average, and often lack sufficient capacity to meet demand, indicating a need for evidence-based allocation of resources to improve their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac Rehabilitation Models around the Globe. Lima de Melo Ghisi, G., Pesah, E., Turk-Adawi, K., et al.[2023]

Home-based cardiac rehabilitation (HBCR) is shown to have a very low incidence of adverse events, with only one severe adverse event reported among 808 participants, translating to a rate of 1 per 23,823 patient-hours of exercise.

No deaths or hospitalizations were linked to HBCR, suggesting it is a safe option for patients, including those in high-risk groups, encouraging them to engage in regular physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of home-based cardiac rehabilitation: A systematic review. Stefanakis, M., Batalik, L., Antoniou, V., et al.[2022]

Home-based cardiac telerehabilitation significantly improves heart rate, VO2 peak, 6-minute walk distance, quality of life, and reduces readmission rates in patients with heart failure, based on a meta-analysis of 16 studies involving 4557 participants.

While home-based telerehabilitation shows benefits, it does not significantly improve left ventricular ejection fraction compared to usual care, and it is not more effective than center-based cardiac rehabilitation in terms of outcome indicators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of home-based cardiac telerehabilitation in patients with heart failure: A systematic review and meta-analysis of randomised controlled trials. Gao, Y., Wang, N., Zhang, L., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05543733

Home Exercise And Resiliency Training (Heart) Club The purpose of this research study is to evaluate the impact of a telemedicine-based structured home exercise program on frailty and exercise capacity in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10880299/

Development and application of a home-based exercise ... This study aimed to develop a home-based CR program and assess the feasibility of the program over a 6-week period in patients with left ventricular ...

3. mhealth.jmir.org mhealth.jmir.org/2024/1/e59098

A Dual-Modality Home-Based Cardiac Rehabilitation Program ... The results of this study show that a dual-modality home-based CR program can be a feasible option to improve access to home-based CR for ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32511110/

Effectiveness of a Home-Based Telehealth Exercise ... Conclusions: A 12-week home-based telehealth exercise training program is feasible and effective in increasing amounts of physical activity, elevating exercise ...

5. ijcscardiol.org ijcscardiol.org/article/home-based-virtual-reality-exercise-program-during-the-maintenance-stage-of-cardiac-rehabilitation-a-randomized-controlled-trial/

Home-based Virtual Reality Exercise Program During the ... To evaluate the effects of a specific, home-based exercise program, performed either through a virtual reality (Kinect) or a conventional format ...

6. clinconnect.io clinconnect.io/trials/NCT05543733

Home Exercise And Resiliency Training (Heart) Club The purpose of this research study is to evaluate the impact of a telemedicine-based structured home exercise program on frailty and exercise capacity in ...

7. withpower.com withpower.com/trial/phase-frailty-9-2022-0e4ca

Home Exercise Program for Heart Condition This trial tests a home exercise program using telemedicine for people with a specific heart condition called Fontan physiology.

8. connectwithcare.org connectwithcare.org/wp-content/uploads/2025/04/mhealth-2024-1-e59098.pdf

A Dual-Modality Home-Based Cardiac Rehabilitation ... Objective: We aimed to assess the feasibility and impact of a digital HBCR program (RecoveryPlus.Health) that integrates both telehealth and mHealth modalities ...