Exercise for Single Ventricle Heart

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Maria Bano

Disqualifiers: Exercise intolerance, Unstable arrhythmia, Heart transplant, Pregnancy, Pacemaker, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 3-6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how exercise can benefit individuals with a single ventricle defect who have undergone a specific surgery (TCPA). Researchers aim to assess exercise's impact on the heart, lungs, and liver, focusing on changes in tissue health and blood flow. Participants will engage in a 3-6 month exercise program and undergo various tests, including MRIs and blood work. Suitable candidates are those aged 10 to 40 who have had this heart surgery and can tolerate exercise. As an unphased trial, this study provides a unique opportunity to contribute to understanding exercise benefits for heart health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this exercise program is safe for Fontan patients?

Research shows that exercise is safe for individuals with a single ventricle heart condition, such as those who have undergone the Fontan procedure. Studies have found that exercise can enhance heart function and improve overall fitness. Importantly, these studies have reported no serious side effects. For those with Fontan circulation, exercise offers a safe method to become stronger and healthier without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using exercise as a treatment for patients with single ventricle heart conditions, like those who have undergone the Fontan procedure, because it offers a non-invasive approach that could improve heart function and overall quality of life. Unlike traditional treatments that focus on medication or surgical interventions to manage symptoms, exercise targets the body's natural ability to strengthen the cardiovascular system. This approach is particularly promising because it could enhance endurance and physical fitness, potentially leading to better long-term outcomes without the side effects associated with more invasive options.

What evidence suggests that exercise is effective for single ventricle heart patients?

Studies have shown that exercise is the best non-surgical way to improve fitness in people with Fontan circulation, a type of heart condition. Research indicates that exercise programs can safely boost at least one measure of fitness in these patients. In this trial, all Fontan patients will engage in an exercise intervention 2-6 times per week for 3-6 months. Exercise also positively affects heart function, quality of life, and the ability to perform physical tasks. These improvements suggest that exercise can be a helpful treatment for those living with a single-ventricle heart condition. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals aged 10-40 with a congenital heart defect leading to single ventricle physiology who've had TCPA surgery. They must be able to give informed consent. It's not for pregnant or breastfeeding individuals, those with pacemakers, certain heart blocks or arrhythmias, exercise intolerance, unstable arrhythmia at screening time, or those listed for heart transplantation.

Inclusion Criteria

I am between 10 and 40 years old.

Informed consent

I was born with a heart defect that results in having only one working heart chamber.

Exclusion Criteria

You have a history of not being able to exercise well.

I do not have an irregular heartbeat that is currently uncontrolled.

You are currently on the waiting list for a heart transplant or being checked to see if you need one.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo MRI of the Fontan circulation, blood draw for serum biomarkers, and exercise testing

1-2 weeks

1 visit (in-person)

Treatment

Participants engage in a cardiac rehabilitation program with exercise intervention 2-6 times/week

3-6 months

Frequent phone follow-up and data download from heart rate monitors

Follow-up

Participants return for follow-up and repeat all testing completed at enrollment

1-2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Exercise

Trial Overview The study tests how exercise affects Fontan patients by using MRI scans of the heart, lung and liver before and after a 3-6 month cardiac rehab program. Blood tests will also measure biomarkers and microRNAs related to their condition.

How Is the Trial Designed?

Group I: Fontan Patients Experimental Treatment 1 Intervention

All Fontan patients included in this study will be part of an exercise intervention 2-6 times/week for 3-6 months.

Who Is Running the Clinical Trial?

Maria Bano

Lead Sponsor

Trials

1

Recruited

50+

Published Research Related to This Trial

Regular exercise training significantly improves quality of life and survival rates in both healthy individuals and patients with cardiovascular diseases, including those with stable heart failure.

In patients with heart failure classified as NYHA functional classes II and III, exercise training alleviates symptoms, enhances exercise capacity, and may reduce hospitalizations and mortality, highlighting its importance as a recommended treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training in chronic heart failure: mechanisms and therapies. Piepoli, MF.[2022]

The HF-ACTION trial aims to determine if exercise training can reduce all-cause mortality and hospitalization in patients with heart failure, involving 36 supervised sessions followed by home-based exercise over a 4-year period.

Exercise training is a low-cost and accessible intervention that may improve health outcomes for heart failure patients, with various physiological and quality-of-life measures being assessed throughout the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heart failure and a controlled trial investigating outcomes of exercise training (HF-ACTION): design and rationale. Whellan, DJ., O'Connor, CM., Lee, KL., et al.[2007]

Recent studies indicate that regular exercise training is safe and effective for patients with stable Class II and III heart failure, improving exercise tolerance and quality of life.

Moderate physical activity, such as 30 to 60 minutes of walking or cycling 3 to 5 days a week, can help reverse some muscle abnormalities and reduce stress on the heart, but more research is needed to fully understand its impact on long-term health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training in heart failure. Afzal, A., Brawner, CA., Keteyian, SJ.[2019]

Patients with congenital heart disease are at risk for being overweight and having low physical activity, making lifestyle measures crucial for their health.

Exercise testing is primarily used to ensure safety during physical activity, and systematic training programs have been shown to be safe for small groups of these patients, although data on their effects are limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and training in adults with congenital heart disease. Thaulow, E., Fredriksen, PM.[2007]

High-intensity interval training (HIIT) is as effective, if not more so, than traditional moderate-intensity continuous training (MICT) for patients with cardiovascular disease, based on a systematic review of 23 studies involving 1117 participants.

The safety profile of HIIT in cardiac rehabilitation is promising, with only one major cardiovascular adverse event reported per 17,083 training sessions, indicating that HIIT can be safely implemented in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training for Patients With Cardiovascular Disease-Is It Safe? A Systematic Review. Wewege, MA., Ahn, D., Yu, J., et al.[2021]

Adults with congenital heart disease generally have lower exercise capacity compared to the general population, but regular exercise is safe and can provide significant physical and psychosocial benefits.

Despite common health fears, evidence supports that exercise training is beneficial and should be encouraged, with tailored recommendations based on individual conditions and risks, particularly regarding the type and intensity of exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risks and Benefits of Exercise Training in Adults With Congenital Heart Disease. Chaix, MA., Marcotte, F., Dore, A., et al.[2022]

A study involving 40 adults with moderate to severe congenital heart disease showed that home-based, self-selected exercise training is safe and well-tolerated, with no participants discontinuing due to exercise-related issues.

Participants who engaged in the exercise program experienced a significant improvement in their exercise capacity, as indicated by a 1.7 ml∙kg∙min-1 increase in peak VO2, while the control group showed no significant change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of home-based, self-selected exercise training in symptomatic adults with congenital heart disease: A prospective, randomised, controlled trial. van Dissel, AC., Blok, IM., Hooglugt, JQ., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9224792/

Exercising with a Single Ventricle: Limitations and Therapies Currently, exercise training is the most effective, noninvasive therapy for improving aerobic capacity in patients with Fontan circulation [32].

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12505337/

Effects of Exercise Training in Patients With Fontan Circulation The Fontan procedure in patients with single-ventricle physiology has improved survival rates in recent years, with a reported 25-year survival rate of 83%.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772812922000409

Exercise Capacity and Training Programs in Paediatric ... Overall, the results indicate that exercise training programs can safely and effectively improve at least 1 measure of exercise capacity in paediatric Fontan ...

4. academic.oup.com academic.oup.com/eurjpc/article/28/11/1269/6374139

Physical exercise training in patients with a Fontan circulation Exercise training in Fontan patients is most likely safe and has positive effects on exercise capacity, cardiac function and quality of life.

5. ahajournals.org ahajournals.org/doi/10.1161/JAHA.122.027464

Peak Work Rate Increases With Lower Extremity‐Focused ... Peak work rate and anaerobic activity increased with lower extremity‐focused training in adolescents with Fontan circulation.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05617534

Impact of Exercise Training on Single Ventricle Function in ... It has been shown to be safe in children with congenital heart disease and with Fontan circulation, it improves their aerobic exercise capacity which is ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1058981320301831

The Fontan circulation: Is exercise training the solution? Exercise training is safe and the most effective, non-invasive 'therapy' to improve exercise capacity in the Fontan population.

8. e-kcj.org e-kcj.org/pdf/10.4070/kcj.2024.0381

Effects of Exercise Training in Patients With Fontan ... Conclusions: Exercise training is effective for improving exercise capacity in patients after the Fontan procedure, particularly when initiated ...

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

Exercise Intolerance, Benefits, and Prescription for People ... Safety of Physical Activity and Exercise Training. Reviews of exercise training studies in people with a Fontan circulation have not reported any serious ...