Breathing & Blood Pressure

Recruiting

• Conditions: Overweight and Obesity; Healthy

• Registration Number: NCT05632406
• Lead Sponsor: Florida State University

Brief Summary

The purpose of this study is to determine the effect of obesity on cardiovascular responses during various breathing maneuvers.

Detailed Description

Adults with higher body mass can have trouble breathing during exercise, which could be due to high respiratory muscle workloads. These breathing muscles can require a lot of energy, which takes away energy from other (e.g., leg) muscles. Participating in this study will help us understand how the heart and blood vessels respond during brief exercise and during various breathing maneuvers.

Study Timeline

• Study First Submitted: 2022-11-14
• Study First Submitted QC: 2022-11-18
• Study First Posted: 2022-11-30
• Study Start: 2023-10-25
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-09
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood pressure during exercise	Up to one week	Systolic and diastolic blood pressure measured in the laboratory at rest and during an incremental aerobic exercise test

Secondary Outcome Measures

Name	Time	Method
Blood pressure during respiratory muscle testing	Up to one week	Systolic and diastolic blood pressure measured in the laboratory at rest and during a respiratory muscle exercise test (eucapnic voluntary hyperpnea)

Trial Locations

Locations (1)

Florida State University; 🇺🇸 Tallahassee, Florida, United States