Inspiratory muscle strength training for adults with obesity

Time-Efficient Inspiratory Muscle Strength Training as a New Approach to Lower Blood Pressure, Improve Respiratory Function, and Reduce Exertional Dyspnea in Adults With Obesity

This study is testing if a special breathing exercise can help lower blood pressure in adults with obesity who have trouble doing regular workouts.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Florida State University (other)
• Locations: 1 site (Tallahassee, Florida)
• Trial ID: NCT05459636 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effects of high-resistance inspiratory muscle strength training (IMST) on blood pressure in adults with obesity. Participants will undergo eight weeks of daily IMST, with a control group receiving very-low-resistance IMST. The study is designed as a randomized, double-blinded, sham-controlled trial to assess improvements in blood pressure, respiratory muscle function, and exertional dyspnea. The research addresses the challenge that many adults with obesity face in performing aerobic exercise due to physical limitations.

Who should consider this trial

Good fit: Ideal candidates are adults with a body mass index between 30 and 40 kg/m2 who are stable in weight.

Not a fit: Patients with uncontrolled hypertension, significant comorbidities, or recent tobacco use may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could provide a novel, accessible method for reducing blood pressure and improving respiratory function in adults with obesity.

How similar studies have performed: Emerging data from other clinical populations suggest that high-resistance inspiratory muscle strength training may be effective, but this specific application in obesity is relatively novel.

Eligibility criteria

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 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 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.

Where this trial is running

Tallahassee, Florida

• Florida State University — Tallahassee, Florida, United States (RECRUITING)

Study contacts

• Study coordinator: Joseph C Watso, PhD

Conditions: Obesity