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Clinical Trials/NCT05632406
NCT05632406
Recruiting
Not Applicable

Breathing & Blood Pressure

Florida State University1 site in 1 country80 target enrollmentOctober 25, 2023

Overview

Phase
Not Applicable
Intervention
Adults without obesity
Conditions
Healthy
Sponsor
Florida State University
Enrollment
80
Locations
1
Primary Endpoint
Blood pressure during exercise
Status
Recruiting
Last Updated
3 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 25, 2023
End Date
June 30, 2027
Last Updated
3 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Joseph Watso

Assistant Professor

Florida State University

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.

Arms & Interventions

Adults without obesity

body mass index below 30 kg/m\^2

Adults with obesity

body mass index above 30 kg/m\^2

Outcomes

Primary Outcomes

Blood pressure during exercise

Time Frame: Up to one week

Systolic and diastolic blood pressure measured in the laboratory at rest and during an incremental aerobic exercise test

Secondary Outcomes

  • Blood pressure during respiratory muscle testing(Up to one week)

Study Sites (1)

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