Inspiratory Muscle Strength Training in Adults With Obesity
The purpose of this study is to determine whether inspiratory muscle strength training reduces blood pressure in adults with obesity.
Conditions:
๐Ÿฆ  Obesity
๐Ÿ—“๏ธ Study Start (Actual) 7 December 2023
๐Ÿ—“๏ธ Primary Completion (Estimated) 30 June 2027
โœ… Study Completion (Estimated) 31 July 2027
๐Ÿ‘ฅ Enrollment (Estimated) 44
๐Ÿ”ฌ Study Type INTERVENTIONAL
๐Ÿ“Š Phase NA
Locations:
๐Ÿ“ Tallahassee, Florida, United States

๐Ÿ“‹ Eligibility Criteria

Description

    Inclusion Criteria:

    • - Body mass index 30 - 40 kg/m2

    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)
    • * Pregnant (self-reported and confirmed via urine pregnancy test), lactating (self-reported), or post-menopausal (self-reported) females
    • * Prisoners
    • * Per the POWERbreatheยฎ 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 dyspnea.
    • * 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 training.
    • * If an individual is suffering from a cold, sinusitis or respiratory tract infection, it is advised that they do not use the POWERbreathe device.
Ages Eligible for Study: 20 Years to 45 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

๐Ÿ—“๏ธ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 13 July 2022
  • First Submitted that Met QC Criteria 13 July 2022
  • First Posted 15 July 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 19 June 2024
  • Last Update Posted 21 June 2024
  • Last Verified June 2024