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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a heart coherence program, called Heartmath, can assist individuals with Vascular Ehlers-Danlos Syndrome (VEDS) in managing stress and anxiety, common challenges for those with this condition. VEDS is a severe form of Ehlers-Danlos Syndrome that affects connective tissue, increasing the risk of serious health issues like arterial tears. By employing biofeedback techniques, the trial seeks to determine if patients can better control their stress response and enhance their quality of life. Individuals diagnosed with VEDS who have access to a smartphone and stable internet may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could improve stress management for VEDS patients.

Will I have to stop taking my current medications?

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

What prior data suggests that Heart Coherence Training is safe for patients with Vascular Ehlers-Danlos Syndrome?

Research shows that Heartmath Intervention, also known as Heart Coherence Training, is generally safe. Studies on stress management indicate that it helps reduce stress, anxiety, and high blood pressure, suggesting the treatment is well-tolerated. No reports of serious side effects have emerged from this program. Instead, participants have experienced improvements in symptoms like body aches, indigestion, and rapid heartbeats. This suggests that the treatment aids both mental well-being and some physical symptoms. Overall, evidence suggests that Heartmath is a safe option for managing stress-related issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Heartmath Intervention for Ehlers-Danlos Syndrome (EDS) because it offers a non-invasive, mind-body approach that focuses on heart coherence training. Unlike conventional treatments for EDS, which often involve pain management through medications or physical therapy, this technique emphasizes emotional regulation and stress reduction via biofeedback and breathing exercises. By potentially improving autonomic nervous system function and enhancing heart rate variability, Heartmath could provide a complementary or alternative strategy to help manage EDS symptoms, offering hope for improved quality of life for patients.

What evidence suggests that the Heartmath Intervention is effective for VEDS?

Research shows that Heartmath®, a heart training program, can reduce stress, anxiety, and high blood pressure. Studies have found that it improves the heart's steady and calm beating. In one study, participants reported a 44% reduction in body aches and a 63% decrease in rapid heartbeats after using the program. In this trial, the experimental group will receive Heartmath® training to manage the body's stress response system, potentially benefiting people with VEDS by easing stress and anxiety symptoms. ^{1 2 3 4 5}

Who Is on the Research Team?

Shaine A Morris, MD, MPH

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05994664

Heart Coherence Training on Vascular Ehlers-Danlos ... One such program, Heartmath®, has been successful in helping patients lower stress, anxiety, and systolic blood pressure. This pilot trial was established to ...

2. researchgate.net researchgate.net/publication/378903550_A_HeartMath_intervention_focusing_on_coherence_resilience_and_faith_following_a_trauma

(PDF) A HeartMath intervention, focusing on coherence ... Quantitatively, there were significant post-intervention positive improvements in physiological average coherence, achievement, and low, medium ...

3. withpower.com withpower.com/trial/phase-ehlers-danlos-syndrome-8-2023-97f85

Heart Coherence Training for Ehlers-Danlos Syndrome Trial Overview The study tests the effectiveness of Heartmath®, a virtual heart coherence program designed to help manage stress, anxiety, and blood pressure in ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05994664/heart-coherence-training-on-vascular-ehlers-danlos-syndrome-patients

Heart Coherence Training on Vascular Ehlers-Danlos ... One such program, Heartmath®, has been successful in helping patients lower stress, anxiety, and systolic blood pressure. This pilot trial ...

5. heartmath.com heartmath.com/about/outcomes/

Outcomes 44% improvement in body aches (joint pain, back aches, etc.) · 43% improvement in indigestion, heart burn or stomach upset · 63% improvement in rapid heartbeats ...