Breathing-muscle training to improve brain blood flow and immune function in people with obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants with obesity will be randomized to an 8-week program of high‑intensity or low‑intensity inspiratory muscle strength training performed at home. Investigators will measure cerebrovascular reactivity and cerebral autoregulation using transcranial Doppler, along with systemic immune‑inflammation markers before and after the intervention. The protocol is time-efficient and modeled on programs that have improved peripheral vascular and heart health. The single-site study is conducted at Florida State University and excludes people with major cardiovascular, respiratory, metabolic, or recent smoking history.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Body mass index greater than or equal to 30 kg/m2
* Waist circumference greater or equal to 88 cm for females and greater than or equal to 102 cm for males

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 it's running

• Florida State University
  Tallahassee, Florida, United States Recruiting

Study contacts

• Principal investigator: Joseph C Watso, PhD — Florida State University
• Study coordinator: Thomas Bissen, MS
• Email: tgb23@fsu.edu
• Phone: 9522121833

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.