Breathing & Blood Pressure

NCT05632406 | Recruiting

• 1 other identifier: STUDY00003469
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy; Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• Blood pressure during exercise

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

  Up to one week

Secondary Outcomes (1)

• Blood pressure during respiratory muscle testing

  Up to one week

Study Arms (2)

Adults without obesity

body mass index below 30 kg/m\^2

Adults with obesity

body mass index above 30 kg/m\^2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Individuals living in, or near, Tallahassee, FL, USA

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joseph Watso, PhD

  Florida State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph Watso, PhD

CONTACT

850-644-5260; jwatso@fsu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: November 30, 2022
• Study Start: October 25, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: One year after completion of the trial, indefinitely
• Access Criteria: A formal plan identifying the intended use of the data and proper completion of appropriate data and/or material transfer agreement approvals with the study PI and their institution.

Locations

US (1)