Breathing Exercise Training for Rapid Heartbeat

Overseen By Madison Maxwell, B.S.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Must not be taking: Narcotics, Hormones, others

Disqualifiers: Neurological disorders, Unstable medical disorders, others

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

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether breathing exercises can help people with Postural Tachycardia Syndrome (POTS), a condition that causes the heart to beat faster when standing. Researchers aim to understand how these exercises might enhance communication between different parts of the brain. The trial suits those diagnosed with POTS or similar conditions who have an upcoming visit to the VCU Comprehensive Autonomics Center. Participants should not have major ongoing health issues, such as severe heart or liver problems. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve future treatment options for POTS.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those using certain unapproved drugs or medical devices, and those using hormones other than insulin, thyroid replacement, or oral contraceptives. It's best to discuss your specific medications with the trial team.

What prior data suggests that this breathing exercise training is safe for people with POTS?

Research shows that breathing exercises are generally safe. Studies have found that these exercises can lower blood pressure and heart rate without causing harm. People with chronic heart failure and high blood pressure have used them safely, with no reported side effects. This indicates that breathing exercises are well-tolerated and unlikely to cause problems. Therefore, for those considering joining a trial for breathing exercise training, evidence supports its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for rapid heartbeat, which often involve medications like beta-blockers or calcium channel blockers, breathing exercise training offers a non-pharmacological approach. This technique is unique because it harnesses the power of controlled breathing to potentially regulate heart rate naturally, without the side effects associated with drugs. Researchers are excited about this method as it might provide a sustainable, easy-to-implement solution that could improve quality of life for patients without the need for medication.

What evidence suggests that breathing exercise training is effective for POTS?

Research has shown that breathing exercises, which participants in this trial will undergo, can help manage heart rate and stress. One review found that these exercises lower heart rate by about 1.72 beats per minute. Another study found that deep belly breathing reduces heart rate by an average of 7.35 beats per minute. Breathing exercises can also boost mood and quality of life, especially for people with heart failure. These findings suggest that breathing exercises might help people with Postural Tachycardia Syndrome (POTS) by controlling rapid heartbeat and improving well-being. ^{1 3 5 6 7}

Who Is on the Research Team?

Thomas Chelimsky, M.D.

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 18-50 with Postural Orthostatic Tachycardia Syndrome (POTS). It's not suitable for those with chronic neurological conditions other than POTS, inflammatory arthritis, autoimmune disorders, or unstable medical issues like severe kidney or liver problems and poorly controlled heart disease.

Inclusion Criteria

Can speak and read in English

I have an appointment at the VCU Autonomics Center in at least a week.

I have been diagnosed with POTS or experience fainting or near-fainting.

Exclusion Criteria

Investigators and study staff

I am not using hormones, except for insulin, thyroid replacements, or birth control.

Any on-going or pending medical, health or disability related litigation, or current pursuit of disability

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo breathing exercise training to improve vagal function and practice this training

6 weeks

Assessed at baseline, week 3, and week 6

Follow-up

Participants are monitored for changes in various psychological and physiological measures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Breathing Exercise Training

Trial Overview

The study tests if breathing exercise training can improve brain communication in people with POTS. Participants will practice these exercises to see their effect on the condition and brain function related to the periaqueductal gray area.

How Is the Trial Designed?

Group I: Training Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

Published Research Related to This Trial

Heart Rate Variability Biofeedback (HRVB) can improve cardiovascular health by utilizing different breathing protocols, with three main types identified: Optimal RF, Individual RF, and Preset-pace RF, based on 143 studies reviewed.

Many studies lack detailed reporting on HRVB protocols, making it difficult to replicate results; thus, the authors recommend methodological guidelines to improve the quality and transparency of future HRVB research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methods for Heart Rate Variability Biofeedback (HRVB): A Systematic Review and Guidelines. Lalanza, JF., Lorente, S., Bullich, R., et al.[2023]

Heart rate variability biofeedback (HRVB) training, particularly through resonance frequency (RF) breathing, significantly improves heart rate variability (HRV) and positive mood, as shown in a study with three groups of participants.

The RF breathing group exhibited a higher LF/HF HRV ratio and lower systolic blood pressure compared to the control group, indicating that RF breathing is an effective method for enhancing HRV and reducing stress responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Resonance Frequency Breathing on Measures of Heart Rate Variability, Blood Pressure, and Mood. Steffen, PR., Austin, T., DeBarros, A., et al.[2020]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10765252/

Effect of breathing exercises on blood pressure and heart rate

In a comprehensive systematic review and meta-analysis of breathing exercises and its effect on BP and HR, there is a moderate but significant positive effect.

2.

withpower.com

withpower.com/trial/phase-tachycardia-11-2022-b12bf

Breathing Exercise Training for Rapid Heartbeat

Research shows that breathing exercises can improve heart rate and mood, and reduce stress. In heart failure patients, breathing exercises have been shown to ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6789387/

Respiratory training interventions improve health status of ...

Prior studies indicate that doing breathing exercises improves physical performance and quality of life (QoL) in heart failure patients.

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0002914917306185

Meta-Analysis of Effects of Voluntary Slow Breathing ...

Practice of the breathing exercises resulted in statistically significant HR reduction (mean difference: −1.72 beats/min, 95% CI −2.70 to −0.75). Reductions ...

5.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/ene.16402

Deep abdominal breathing reduces heart rate and ...

During the breathing technique, the mean HR increase was −7.35 bpm (95% confidence interval [CI] = −11.71 to −2.98), and the maximum HR increase ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05404672

Breathing Exercises With And Without Aerobic Training In ...

Experimental group will be treated by Progressive Breathing Retraining Exercise Program-2 times a day for 15 minutes, initially Controlled Nasal Breathing with ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9307357/

Effectiveness and Safety of Four Aerobic Exercise Intensity ...

All four techniques are safe in low- and moderate-risk patients. In high-risk patients, using HRR method A has certain risks.