53 Participants Needed

Home Exercise Program for Heart Condition

BA
Overseen ByBlake Armstrong
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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).

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.12345

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.56789

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.567810

Who Is on the Research Team?

JH

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
See 5 more

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?
1Treatment groups
Experimental Treatment
Group I: Home exercise programExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials
1,891
Recruited
6,458,000+

Published Research Related to This Trial

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.
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.
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.
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

Home-based cardiac rehabilitation improves quality of life, aerobic capacity, and readmission rates in patients with chronic heart failure. [2018]
How to do: telerehabilitation in heart failure patients. [2019]
Effectiveness of home-based cardiac telerehabilitation in patients with heart failure: A systematic review and meta-analysis of randomised controlled trials. [2023]
Effects of home-based cardiac exercise program on the exercise tolerance, serum lipid values and self-efficacy of coronary patients. [2019]
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]
A systematic review of recent cardiac rehabilitation meta-analyses in patients with coronary heart disease or heart failure. [2020]
Cardiac Rehabilitation Models around the Globe. [2023]
Safety of home-based cardiac rehabilitation: A systematic review. [2022]
Exercise training and cardiac rehabilitation in cardiovascular disease. [2019]
Home-based cardiac rehabilitation versus hospital-based rehabilitation: a cost effectiveness analysis. [2022]
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