Understanding how obesity affects breathing and heart responses

Breathing & Blood Pressure

This study looks at how being overweight affects breathing and heart responses during exercise to help understand the connection between obesity and heart health.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Florida State University (other)
• Locations: 1 site (Tallahassee, Florida)
• Trial ID: NCT05632406 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the impact of obesity on cardiovascular responses during different breathing maneuvers in adults. It focuses on how higher body mass may influence breathing difficulties during exercise, potentially due to increased respiratory muscle workload. By analyzing heart and blood vessel responses during brief exercise and various breathing techniques, the study seeks to provide insights into the relationship between obesity and cardiovascular health.

Who should consider this trial

Good fit: Ideal candidates are adults with a body mass index of 40 kg/m² or less who are weight stable.

Not a fit: Patients with significant cardiovascular, neurological, or metabolic illnesses, or those with a history of uncontrolled hypertension, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of cardiovascular health in obese individuals, leading to better management strategies.

How similar studies have performed: While similar studies have explored the relationship between obesity and cardiovascular responses, this specific approach focusing on breathing maneuvers is relatively novel.

Eligibility criteria

Inclusion Criteria:

• Body mass index values of ≤40 kg/m\^2

Exclusion Criteria:

* Not weight stable (\<5% change in body mass over the past six months)
* Overt cardiovascular, neurological, renal, liver, and/or metabolic illness (e.g., diabetes mellitus)
* Current, or history of uncontrolled, Stage 2 hypertension (blood pressure \>140 / 90 mmHg; anti-hypertensive medications are permitted)
* Diagnosed obstructive sleep apnea
* Previous bariatric surgery
* Diagnosis or signs (e.g., values below the lower limit of normal) of overt airway disease(s)
* Current or recent (regular use within the past 6 months) use of tobacco or nicotine products (e.g., cigarettes, vaping)
* Per the POWERbreathe® company:
* Patients who have undergone recent abdominal surgery and those with abdominal hernia.
* Asthma patients who have a very low symptom perception and suffer from frequent, severe exacerbations or with an abnormally low perception of dyspnoea.
* If a patient is suffering from a ruptured eardrum or any other condition of the ear.
* Patients with marked elevated left ventricular end-diastolic volume and pressure.
* Patients with worsening heart failure signs and symptoms after a respiratory/inspiratory muscle training (IMT) session
* If you are suffering from a cold, sinusitis, or respiratory tract infection, we advise that you do not use your POWERbreathe IMT device.
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant (self-reported and urine pregnancy test conducted), lactating (self-reported), or post-menopausal (self-reported) females
* Prisoners

Where this trial is running

Tallahassee, Florida

• Florida State University — Tallahassee, Florida, United States (RECRUITING)

Study contacts

• Principal investigator: Joseph Watso, PhD — Florida State University
• Study coordinator: Joseph Watso, PhD

Conditions: Healthy, Overweight and Obesity