Wellness & Exercise Program for Single Ventricle Heart Disease

Overseen By Blake Armstrong

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must not be taking: Intravenous inotropic drugs

Disqualifiers: Severe ventricular dysfunction, arrhythmia, others

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

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a wellness education program, combined with a personalized exercise plan, can help children with Fontan physiology, a type of heart condition. It aims to determine if these programs can boost wellness, increase daily activity, and improve overall life quality without causing heart problems. The trial is suitable for English-speaking teens with this heart condition who have a mobile device for program access. Participants will first join the WE BEAT Group Wellness Education program and then move on to the HEART Club Home Exercise program. The study also evaluates whether the program is easy to follow and effectively reduces frailty and increases fitness levels. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance the quality of life for those with Fontan physiology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on intravenous inotropic drugs, you would not be eligible to participate.

What prior data suggests that this wellness and exercise program is safe for pediatric patients with Fontan physiology?

Research has shown that wellness and exercise programs for children with single ventricle heart disease are generally safe. In one study, the Heart Chargers program, a home-based exercise plan for children with Fontan circulation, reported no harmful effects, suggesting that similar programs are well-tolerated.

Another report highlighted the HEART Club, a telemedicine exercise program, which improved participants' physical abilities and quality of life. These findings support the safety and positive impact of such programs for children with heart conditions.

Overall, these programs appear promising and are expected to be safe for participants, aiming to improve health and daily activity levels without causing serious heart problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these programs for single ventricle heart disease because they take a holistic approach that combines physical exercise with wellness education, which is different from the typical focus on medical or surgical interventions. The HEART Club Home Exercise program encourages patients to engage in regular physical activity at home, which can improve heart function and overall health without invasive procedures. Meanwhile, the WE BEAT Group Wellness Education program empowers patients with knowledge and community support, potentially leading to better adherence to lifestyle changes and improved quality of life. This dual approach aims to enhance patient outcomes by addressing both physical and mental well-being.

What evidence suggests that this program is effective for improving wellness and activity levels in pediatric patients with Fontan physiology?

Research shows that home-based exercise programs can benefit children who have undergone the Fontan procedure, a common surgery for certain heart defects. In this trial, participants will take part in the HEART Club Home Exercise program, designed to enhance heart health, movement, and overall well-being. Studies have found that exercise can improve heart health, mobility, and overall well-being in these children. Many patients have experienced better oxygen use and increased daily activity. Overall, these exercise programs can significantly impact children living with Fontan physiology. ^{1 3 4 6 7}

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 young people aged 13 to <19 with Fontan physiology, a type of heart condition. They must be able to give consent or have it from a guardian, own a mobile device compatible with the study's app, and speak English fluently. Those with severe heart issues, recent suicidality or homicidality, certain height restrictions, IV drug use for heart failure, exercise-induced arrhythmias, inability to complete baseline exercise tests or other conditions that could interfere are excluded.

Inclusion Criteria

I am between 13 and 18 years old with Fontan physiology.

Fluent in English

Own a mobile device capable of installing the University of Michigan Patient Portal application

Exclusion Criteria

I am shorter than 130 centimeters.

My heart's pumping ability is severely impaired, confirmed by an echo test within the last 6 months.

You have a history of irregular heartbeats during exercise, except for occasional harmless extra heartbeats without any symptoms.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

WE BEAT Group Wellness Education Program

Participants engage in a small-group wellness education program

6 weeks

Virtual sessions

HEART Club

Participants transition to an individualized prescription exercise program

6 months

Monthly virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after the exercise program

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HEART Club Home Exercise program - phase 2
• WE BEAT Group Wellness Education program - phase 1

Trial Overview The trial evaluates a two-phase program on wellness in pediatric patients with Fontan physiology. Phase one involves group wellness education (WE BEAT), followed by an individualized home exercise regimen (HEART Club). It aims to see if these interventions can safely improve frailty status, oxygen consumption during peak activity levels, daily step counts and overall quality of life without causing serious cardiac events.

How Is the Trial Designed?

Group I: Wellness education and Home exercise programs Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Reuben Phoenix Schostak Fontan Wellness Project Fund

Collaborator

Trials

1

Recruited

30+

Published Research Related to This Trial

The Heart Chargers program, a 12-month home-based exercise program for Fontan patients, was implemented safely with no adverse events, demonstrating feasibility through telemedicine support.

Participants showed a significant increase in systolic blood pressure and minute ventilation at peak exercise, while maintaining their exercise capacity, which is promising for long-term outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Project: Heart Chargers-A Successful Model for a Home-Based Physical Activity Program Utilizing Telemedicine for Fontan Patients. Fernie, JC., Wylie, L., Schäfer, M., et al.[2023]

A 10-month home-based training program combining cycle ergometer endurance training and inspiratory muscle training in 18 Fontan patients led to significant improvements in maximum workload and respiratory muscle strength, indicating the program's safety and efficacy.

While peak oxygen uptake improved in a subgroup of teenage/adult patients, overall quality of life did not show significant changes after the training period, suggesting that physical improvements may not directly translate to enhanced well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-Based Long-Term Physical Endurance and Inspiratory Muscle Training for Children and Adults With Fontan Circulation-Initial Results From a Prospective Study. Dirks, S., Kramer, P., Schleiger, A., et al.[2022]

An 8-week home exercise training program for adolescents aged 12-19 who underwent Fontan surgery resulted in significant improvements in exercise capacity, with oxygen consumption at anaerobic threshold increasing from 19.3 to 21.6 ml/kg/minute.

The home training program also led to enhanced quality of life scores, with total quality of life improving from 68% to 74%, and no training-related complications were reported, suggesting that home-based exercise is a safe and effective alternative to hospital-based programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home- and hospital-based exercise training programme after Fontan surgery. Sutherland, N., Jones, B., Westcamp Aguero, S., et al.[2018]

A 12-month home-based exercise program for 61 children with single-ventricle physiology after Fontan significantly improved their gross motor skills and increased their daily moderate-to-vigorous physical activity (MVPA) over a 2-year period.

The study found that the type of rehabilitation program did not affect the outcomes, indicating that both prescribed education and exercise programs are effective in enhancing physical activity and fitness in these children, regardless of their location.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based rehabilitation enhances daily physical activity and motor skill in children who have undergone the Fontan procedure. Longmuir, PE., Tyrrell, PN., Corey, M., et al.[2021]

A 12-week home-based cardiac physical activity program for 14 children aged 8-12 years after Fontan surgery was found to be safe and feasible, with 93% of participants completing the program without any adverse events.

Parents reported significant improvements in their child's health-related quality of life (HRQOL) across various domains, and exercise capacity improved over the study period, indicating potential benefits of home-based physical activity for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can a Home-based Cardiac Physical Activity Program Improve the Physical Function Quality of Life in Children with Fontan Circulation? Jacobsen, RM., Ginde, S., Mussatto, K., et al.[2017]

Paediatric Fontan patients show significantly lower peak exercise capacity compared to their healthy peers, highlighting the need for targeted interventions.

Exercise training programs, lasting from 6 weeks to 12 months, can safely and effectively improve exercise capacity in these patients, with no reported adverse events during the training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Capacity and Training Programs in Paediatric Fontan Patients: A Systematic Review. Herrmann, JE., Selamet Tierney, ES.[2023]

A study involving 29 children with advanced heart failure on ventricular assist devices (VAD) showed that exercise rehabilitation (ER) is safe, with no adverse events reported during 864 completed sessions.

Children began ER an average of 49 days after VAD implantation, indicating that early implementation of exercise can be feasible and may improve functional capacity before heart transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Feasibility of Exercise Rehabilitation in Children with Ventricular Assist Devices. Burstein, DS., McBride, MG., Edelson, JB., et al.[2022]

Exercise training is safe for Fontan patients and can significantly improve their exercise capacity, with a mean increase in peak oxygen uptake of +1.72 ml/kg/min across 56% of the studies reviewed.

The systematic review included 16 studies with 264 Fontan patients aged 8.7 to 31 years, and none of the studies reported negative outcomes directly related to the exercise programs, suggesting that exercise training should be encouraged for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical exercise training in patients with a Fontan circulation: A systematic review. Scheffers, LE., Berg, LEMV., Ismailova, G., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-heart-diseases-1-2022-cea34

Wellness & Exercise Program for Single Ventricle Heart ... Research shows that home-based exercise programs can improve exercise capacity and physical activity levels in patients who have undergone the Fontan procedure, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10642096/

Exercise Capacity and Training Programs in Paediatric Fontan ... This study systematically reviews exercise capacity in paediatric Fontan patients and the impact of training programs on their cardiovascular health.

3. frontiersin.org frontiersin.org/journals/pediatrics/articles/10.3389/fped.2021.799125/full

Exercise Intolerance, Benefits, and Prescription for People ... Most babies who are born with single ventricle physiology and are palliated with the Fontan procedure will now survive into adulthood (1). The Fontan ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8771702/

Exercise Intolerance, Benefits, and Prescription for People ... This manuscript will describe the pathophysiology of exercise intolerance in the Fontan circulation and the rationale and protocol for the F-FIT ...

5. researchgate.net researchgate.net/publication/294940076_Can_a_Home-based_Cardiac_Physical_Activity_Program_Improve_the_Physical_Function_Quality_of_Life_in_Children_with_Fontan_Circulation

Can a Home-based Cardiac Physical Activity Program ... Objective: Patients after Fontan operation for complex congenital heart disease (CHD) have decreased exercise capacity and report reduced health-related ...

6. issuu.com issuu.com/umhs/docs/mott-chc_outcomes24_13025-issuu

CHC Outcomes and Highlights Brochure 2024 HEART Club, a telemedicine-based exercise program, has demonstrated improved function and quality of life among participants and is expanding ...

7. chop.edu chop.edu/centers-programs/fontan-rehabilitation-wellness-activity-and-resilience-development-forward-program

Fontan Rehabilitation, Wellness, Activity and Resilience ... Our Fontan rehabilitation program provides specialized care, evaluation and ongoing monitoring for patients with single ventricle heart defects and Fontan ...