Inspiratory Muscle Strength Training in Adults With Obesity

Last updated: February 4, 2025
Sponsor: Florida State University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obesity

Diabetes Prevention

Treatment

Very-low-resistance inspiratory muscle strength training

High-resistance inspiratory muscle strength training

Clinical Study ID

NCT05459636
STUDY00003098
K01HL160772
  • Ages 18-45
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to determine whether inspiratory muscle strength training reduces blood pressure in adults with obesity.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Body mass index 30 - 40 kg/m2

Exclusion

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 / 90mmHg; 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 airwaydisease(s)

  • Current or recent (regular use within the past 6 months) use of tobacco or nicotineproducts (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 POWERbreathe® company:

  • Patients who have undergone recent abdominal surgery and those with abdominalhernia.

  • Asthma patients who have a very low symptom perception and suffer fromfrequent, severe exacerbations or with an abnormally low perception of dyspnea.

  • If a patient is suffering from a ruptured eardrum or any other condition of theear.

  • Patients with marked elevated left ventricular end-diastolic volume andpressure.

  • Patients with worsening heart failure signs and symptoms after training.

  • If an individual is suffering from a cold, sinusitis or respiratory tractinfection, it is advised that they do not use the POWERbreathe device.

Study Design

Total Participants: 44
Treatment Group(s): 2
Primary Treatment: Very-low-resistance inspiratory muscle strength training
Phase:
Study Start date:
December 07, 2023
Estimated Completion Date:
July 31, 2027

Study Description

Obesity affects four-in-ten American adults and is associated with hypertension and greater all-cause mortality. Irrespective of weight loss, aerobic exercise reduces arterial blood pressure (BP) and improves cardiometabolic health. However, nearly half of adults with obesity do not perform aerobic exercise because of low leisure time availability and exertional dyspnea secondary to high chest wall mass-related inspiratory muscle dysfunction. In other clinical populations, emerging data demonstrates time-efficient high-resistance inspiratory muscle strength training (IMST) reduces BP and improves respiratory muscle function. Therefore, the investigators will determine whether eight weeks of daily high-resistance IMST reduces BP, improves respiratory muscle function, and concomitantly reduces exertional dyspnea in a randomized, double-blinded, sham-controlled (i.e., very low-resistance IMST) clinical trial among adults with obesity

Connect with a study center

  • Florida State University

    Tallahassee, Florida 32306
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.