Breathing & Blood Pressure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-25

Study Completion Date

2027-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Healthy Overweight and Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Adults without obesity

body mass index below 30 kg/m\^2

No interventions assigned to this group

Adults with obesity

body mass index above 30 kg/m\^2

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes