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

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a single center prospective longitudinal exercise training study and will enroll approximately 50 Fontan patients and 20 controls of a similar age, gender, BMI and physical activity level between the ages of 10-40 years. Participants will undergo an MRI of the Fontan circulation. This will include imaging of the heart, lung and liver. This will include specific imaging for tissue characterization and assessment of myocardial fibrosis, liver fibrosis and disproportionate pulmonary blood flow. The investigators will then draw blood (approximately 10 ml) for assessment of serum biomarkers and circulating microRNAs of interest. The participants will undergo exercise testing and will then start a 3-6 month long cardiac rehabilitation program. After the 3-6 month study period the participants will return back for a follow up and repeat all the testing completed at enrollement.

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 data supports the effectiveness of the treatment Exercise, Physical Activity, Workout, Fitness Training for Single Ventricle Heart?

Research shows that regular exercise can improve quality of life and exercise capacity in patients with heart failure, which is a condition where the heart doesn't pump blood as well as it should. Exercise helps by improving muscle function and reducing symptoms like breathlessness and fatigue, which could be beneficial for those with single ventricle heart conditions. ^{1 2 3 4 5}

Is exercise generally safe for people with heart conditions?

Exercise, including high-intensity interval training and aerobic training, is generally safe for people with heart conditions, including those with congenital heart disease. Studies show a low rate of major adverse events and support the safety of exercise training in these populations. ^{6 7 8 9 10}

How does exercise treatment differ from other treatments for single ventricle heart condition?

Exercise treatment for single ventricle heart condition is unique because it focuses on improving physical capacity and heart function through physical activity, rather than using medication or surgery. This approach aims to enhance the body's ability to handle physical exertion, which can be particularly beneficial as patients age, potentially delaying the need for surgical interventions. ^{8 11 12 13 14}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

Heart failure and a controlled trial investigating outcomes of exercise training (HF-ACTION): design and rationale. [2007]

3. Italy pubmed.ncbi.nlm.nih.gov

A review to develop an effective exercise training for heart failure patients. [2009]

4. England pubmed.ncbi.nlm.nih.gov

Exercise for those with chronic heart failure matching programs to patients. [2010]

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

Exercise training in heart failure. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Exercise and training in adults with congenital heart disease. [2007]

7. England pubmed.ncbi.nlm.nih.gov

Risks and Benefits of Exercise Training in Adults With Congenital Heart Disease. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Aerobic training in adults after atrial switch procedure for transposition of the great arteries improves exercise capacity without impairing systemic right ventricular function. [2022]

9. Netherlands 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. [2019]

10. England pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training for Patients With Cardiovascular Disease-Is It Safe? A Systematic Review. [2021]

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

Functional single ventricle: cardiorespiratory response to exercise. [2019]

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

Increasing Pump Speed During Exercise Training Improves Exercise Capacity in Children with Ventricular Assist Devices. [2021]

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

Long-term effects of physical training on coronary patients with impaired ventricular function. [2019]

14. Germany pubmed.ncbi.nlm.nih.gov

[Physical exercise training for cardiovascular diseases]. [2021]