Heart Coherence Training for Ehlers-Danlos Syndrome

Overseen By Jennifer Bogardus, PT, MPT, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Disqualifiers: Non-English speakers, Developmental delays, others

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is Heart Coherence Training safe for humans?

The research on Heart Coherence Training, also known as Heartmath Intervention, suggests it is generally safe for humans. Studies involving stress management programs adapted from Heartmath techniques have been conducted with elderly patients with heart conditions, showing improvements in emotional and physical health without significant safety concerns. ^{1 2 3 4 5}

How is Heart Coherence Training different from other treatments for Ehlers-Danlos Syndrome?

Heart Coherence Training is unique because it uses biofeedback techniques to help patients regulate their heart rhythms through controlled breathing exercises, which can be done using a smartphone app. This non-intrusive approach is different from other treatments as it focuses on improving heart rate variability and stress management, rather than directly addressing the physical symptoms of Ehlers-Danlos Syndrome. ^{6 7 8 9 10}

What is the purpose of this trial?

Vascular Ehlers-Danlos Syndrome (VEDS) is caused by pathogenic variants of the COL3A1 gene, resulting abnormal Type III collagen protein. This impacts the body's connective tissue and makes people with VEDS at high risk of spontaneous aortic and arterial rupture, pneumothorax, and hollow organ perforation across the age spectrum. Given this risk and high potential for lethality, VEDS is considered the most severe type of Ehlers-Danlos Syndrome. In addition, many patients experience chronic pain and fatigue, sleep disturbances, and mental health challenges. As is the case for many patients with chronic illness, stress, anxiety, and depression are often present over the course of the disease. Despite the antecedent, stress and anxiety trigger a sympathetic nervous system (SNS) response in the body, which, over a period of time, can have detrimental effects both physiologically and psychologically for patients. Recent studies have begun to use biofeedback techniques to teach patients non-pharmacological strategies for managing their autonomic nervous system. One such program, Heartmath®, has been successful in helping patients lower stress, anxiety, and systolic blood pressure. This pilot trial was established to assess the effectiveness of a virtually based heart coherence program in a population with a chronic aortopathy in an effort to establish a larger, multi-provider program that also encompasses other cardiovascular populations.

Research Team

Shaine A Morris, MD, MPH

Principal Investigator

Baylor College of Medicine

Eligibility Criteria

This trial is for individuals aged 12-45 with Vascular Ehlers-Danlos Syndrome confirmed by a COL3A1 gene mutation. Participants must have access to a smartphone, another device with camera and microphone, stable internet, and be English-speaking. It excludes non-English speakers or those unable to use technology or follow instructions due to conditions or developmental delays.

Inclusion Criteria

I am between 12 and 45 years old.

I have Vascular Ehlers-Danlos Syndrome confirmed by a COL3A1 gene mutation.

Access to a smartphone as well as an additional device with camera and microphone

Exclusion Criteria

Any conditions or developmental delays limiting the ability to utilize technology or follow directions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an 8-week, virtually-based heart coherence training program using wearable biofeedback technology

8 weeks

Weekly virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of blood pressure, heart rate variability, and mental health

4 weeks

Open-label extension (optional)

Control group participants have access to HeartMath techniques for therapeutic equality

Long-term

Treatment Details

Interventions

• Heartmath Intervention

Trial Overview The study tests the effectiveness of Heartmath®, a virtual heart coherence program designed to help manage stress, anxiety, and blood pressure in patients with chronic aortopathy. The goal is to see if this biofeedback technique can improve mental health without medication.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Group of up to 20 patients will be randomly allocated into an experimental group at a 1:1 ratio intervention to controls. The experimental group will receive all of the preliminary outcome screening with the additional 10-15 minutes of training and advancement on HeartMath techniques as well as continued written and video reinforcement.

Group II: Control Placebo Group 1 Intervention

Group of up to 20 patients will be randomly allocated into a control group at a 1:1 ratio for intervention to controls. The control group will receive all of the preliminary outcome screening and will have weekly virtual sessions that include the 3-step Protocol HRV assessment. After the CG has completed 8 weeks, they will then have access to materials related to the techniques that were taught to the HMI group to allow for therapeutic equality.

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Southern Star Research

Industry Sponsor

Trials

14

Recruited

630+

Southern Star Research Pty Ltd.

Industry Sponsor

Trials

14

Recruited

620+

Findings from Research

Stress management training significantly improved quality of life and functional capacity in elderly patients with congestive heart failure (CHF), as evidenced by reductions in perceived stress and emotional distress, and improvements in depression and walking distance after 10 weeks of training.

While heart rate variability did not show significant changes, the study suggests that psychosocial interventions like stress management can be a valuable complement to traditional medical treatments for CHF, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A controlled pilot study of stress management training of elderly patients with congestive heart failure. Luskin, F., Reitz, M., Newell, K., et al.[2019]

Exercise training is safe and effective for elderly patients with chronic heart failure, significantly increasing their 6-minute walking distance by an average of 50.05 meters and improving their overall health-related quality of life.

However, the exercise training did not lead to significant changes in all-cause mortality, hospitalizations, peak oxygen uptake, or disease-specific quality of life, indicating that while it benefits physical capacity and general well-being, it does not impact survival or hospitalization rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of exercise training in elderly heart failure patients: a systematic review and meta-analysis. Chen, YM., Li, Y.[2018]

In a study of 62 cardiac rehabilitation patients, those who participated in intensive training (six times per week) showed a significant increase in exercise capacity compared to those who trained less frequently, with improvements lasting up to one year after training.

The intensive training group also experienced a greater increase in heart rate variability (HRV), a key indicator of heart health, suggesting that more frequent exercise may enhance cardiac function and potentially reduce the risk of cardiac events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensive home-based exercise training in cardiac rehabilitation increases exercise capacity and heart rate variability. Tygesen, H., Wettervik, C., Wennerblom, B.[2019]

In a study involving 31 coronary artery disease (CAD) patients, those who underwent 10 sessions of heart rate variability biofeedback training showed a significant increase in cardiac coherence and improved SDNN index, suggesting potential benefits for heart function.

While the small sample size limits definitive conclusions, the study indicates that cardiac coherence biofeedback is feasible and may enhance stress management in cardiac rehabilitation programs, warranting further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biofeedback on heart rate variability in cardiac rehabilitation: practical feasibility and psycho-physiological effects. Climov, D., Lysy, C., Berteau, S., et al.[2022]

High-risk cardiac patients showed significant improvements in exercise capacity (VO2peak) and heart function (LVEF) after participating in a 6 to 8 week cardiac rehabilitation program, with no serious cardiovascular events reported during the training.

The improvements in both VO2peak and LVEF in high-risk patients were comparable to those seen in control participants, indicating that cardiac rehabilitation is safe and effective for high-risk individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac Rehabilitation Exercise Training for High-Risk Cardiac Patients. Choi, HE., Kim, C., Sohn, Y.[2020]

Cardiac coherence biofeedback training, which involves slowing breathing to 0.1 Hz, has been shown to effectively improve health in various conditions such as cardiovascular diseases and PTSD over an 8 to 10 week period.

A new smartphone-based solution using photo-plethysmographic imaging allows users to easily perform cardiac coherence biofeedback exercises without the need for additional sensors, making it more accessible for daily use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A smartphone based cardiac coherence biofeedback system. De Jonckheere, J., Ibarissene, I., Flocteil, M., et al.[2020]

Cardiac rehabilitation (CR) is a safe and effective multidisciplinary program that significantly improves quality of life, functional capacity, and reduces hospitalizations related to heart failure in patients.

Despite its proven benefits and strong recommendations, CR is underutilized, highlighting the need for healthcare providers and payers to prioritize its integration into standard care for heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac Rehabilitation for Patients With Heart Failure: JACC Expert Panel. Bozkurt, B., Fonarow, GC., Goldberg, LR., et al.[2021]

A novel modular approach to procedural training in structural heart disease identifies ten key 'building blocks' that can be taught and assessed separately, enhancing the learning process for complex procedures.

This method emphasizes the importance of understanding relational anatomy and device-specific training, which can improve competency in both common and less common structural heart procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building Blocks of Structural Intervention: A Novel Modular Paradigm for Procedural Training. Raphael, CE., Alkhouli, M., Maor, E., et al.[2018]

Exercise training significantly improves symptoms and exercise capacity in patients with stable chronic heart failure (CHF), while also reducing morbidity, mortality, and emergency hospitalizations.

These benefits are consistent across all demographics, including age, sex, and severity of heart failure, and the most effective training involves a combination of supervised in-hospital sessions and community-based exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical utility of exercise training in chronic systolic heart failure. Coats, AJ.[2021]

Exercise training is safe for patients with chronic heart failure (CHF) and has been shown to improve exercise capacity, which is crucial given the debilitating symptoms associated with the condition.

The review of controlled clinical trials suggests that exercise training may also lead to improvements in the underlying pathophysiological changes of CHF, potentially reducing morbidity and mortality rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training in heart failure. Coats, AJ.[2020]

References

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

A controlled pilot study of stress management training of elderly patients with congestive heart failure. [2019]

2. India pubmed.ncbi.nlm.nih.gov

Safety and efficacy of exercise training in elderly heart failure patients: a systematic review and meta-analysis. [2018]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Intensive home-based exercise training in cardiac rehabilitation increases exercise capacity and heart rate variability. [2019]

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

Biofeedback on heart rate variability in cardiac rehabilitation: practical feasibility and psycho-physiological effects. [2022]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Cardiac Rehabilitation Exercise Training for High-Risk Cardiac Patients. [2020]

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

A smartphone based cardiac coherence biofeedback system. [2020]

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

Cardiac Rehabilitation for Patients With Heart Failure: JACC Expert Panel. [2021]

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

Building Blocks of Structural Intervention: A Novel Modular Paradigm for Procedural Training. [2018]

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

Clinical utility of exercise training in chronic systolic heart failure. [2021]

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

Exercise training in heart failure. [2020]