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临床试验/NCT05632406
NCT05632406招募中不适用

Breathing & Blood Pressure

Florida State University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年10月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
Blood pressure during exercise

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

Adults without obesity

body mass index below 30 kg/m^2

Adults with obesity

body mass index above 30 kg/m^2

结局指标

主要结局

Blood pressure during exercise

时间窗: Up to one week

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

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joseph Watso

Assistant Professor

Florida State University

研究点 (1)

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