Breathing & Blood Pressure

Florida State University logo

Florida State University

Status

Enrolling

Conditions

Healthy
Overweight and Obesity

Study type

Observational

Funder types

Other

Identifiers

NCT05632406
STUDY00003469

Details and patient eligibility

About

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

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

20 to 45 years old

Volunteers

No Healthy Volunteers

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

Trial design

80 participants in 2 patient groups

Adults without obesity
Description:
body mass index below 30 kg/m^2
Adults with obesity
Description:
body mass index above 30 kg/m^2

Trial contacts and locations

0

Loading...

Central trial contact

Joseph Watso, PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems