Home Exercise Program for Heart Condition

Overseen by Jesse Hansen, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Michigan

Must not be taking: Intravenous inotropes

Disqualifiers: Pregnancy, Severe ventricular dysfunction, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a home exercise program using telemedicine for people with a specific heart condition called Fontan physiology. The goal is to improve their fitness and reduce barriers to accessing exercise programs. Participants will get online support to help them stay active. Exercise training has been shown to increase exercise capacity in survivors of Fontan surgery.

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 data supports the effectiveness of the treatment Home Exercise Program for Heart Condition?

Research shows that home-based cardiac rehabilitation can improve quality of life and exercise capacity in heart failure patients. Additionally, home telerehabilitation is considered an optimal form of physical activity for these patients, as it helps overcome barriers to traditional rehabilitation. ^{1 2 3 4 5}

Is a home exercise program for heart conditions safe for humans?

Research indicates that home-based cardiac rehabilitation programs are generally feasible and effective, but there is limited evidence specifically addressing safety issues across different heart conditions. ^{4 6 7 8 9}

How is the Home Exercise Program for Heart Condition different from other treatments?

The Home Exercise Program for Heart Condition is unique because it is a telemedicine-based structured exercise program that patients can do at home, making it more accessible and convenient compared to traditional hospital-based rehabilitation. This approach helps overcome barriers like patient rejection of existing rehabilitation forms and limitations due to the heart condition itself, offering a flexible and effective way to improve exercise tolerance and quality of life. ^{1 2 4 5 10}

Research Team

Jesse Hansen, MD

Principal Investigator

University of Michigan

Eligibility Criteria

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.

I am 18 years old or older.

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

Trial Timeline

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

Treatment Details

Interventions

• Home exercise program (Behavioral Intervention)

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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, 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]

References

1. 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]

2. Poland pubmed.ncbi.nlm.nih.gov

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

3. England 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. [2023]

4. England 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. [2019]

5. United States 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. [2007]

6. England pubmed.ncbi.nlm.nih.gov

A systematic review of recent cardiac rehabilitation meta-analyses in patients with coronary heart disease or heart failure. [2020]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Cardiac Rehabilitation Models around the Globe. [2023]

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

Safety of home-based cardiac rehabilitation: A systematic review. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Exercise training and cardiac rehabilitation in cardiovascular disease. [2019]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Home-based cardiac rehabilitation versus hospital-based rehabilitation: a cost effectiveness analysis. [2022]