Breathing-muscle training to improve brain blood flow and immune function in people with obesity
Novel Respiratory Muscle Training for Improving Cerebrovascular Function and Immune Status in Adults With Obesity
NA · Florida State University · NCT07406295
This study will test whether 8 weeks of inspiratory muscle strength training (a short daily breathing workout) can improve brain blood flow and immune markers in otherwise healthy young adults with obesity.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Florida State University (other) |
| Locations | 1 site (Tallahassee, Florida) |
| Trial ID | NCT07406295 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Otherwise healthy young adults with obesity (BMI ≥30 kg/m2 and waist circumference ≥88 cm for females or ≥102 cm for males) who are weight-stable and without major chronic illnesses are ideal candidates.
Not a fit: People with overt cardiovascular, neurological, renal, liver, or metabolic disease (including diabetes), diagnosed obstructive sleep apnea, recent tobacco/nicotine use, prior bariatric surgery, overt airway disease, pregnancy or lactation, or who are post‑menopausal are unlikely to be eligible or to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, this could provide a low-cost, home-based way to improve brain vascular health and reduce inflammation in younger adults with obesity.
How similar studies have performed: Early studies have shown IMST can improve peripheral vascular and some cerebrovascular measures in adults with elevated blood pressure, but its effects in younger adults with obesity remain novel and unconfirmed.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Tallahassee, Florida
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obesity, Cerebrovascular Function, Immune Cells Activity, Transcranial Doppler, Inspiratory Muscle Strength Training, Cerebrovascular Reactivity