NCT07406295 Respiratory Muscle Training to Improve Cerebrovascular and Immune Function
| NCT ID | NCT07406295 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Florida State University |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-01-27 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2026-01-27 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Millions of adults in America have too much body fat, resulting in obesity. Obesity is detrimental to health and causes disease. Obesity reduces brain health, which causes the brain to function less effectively. Additionally, a lack of exercise contributes to poorer brain health. Most individuals feel they do not have time to exercise. There is a need for a quicker type of training that improves brain health. Newly developed breathing exercises could be a time-efficient, cost-effective, and home-based practice to increase brain health. This practice acts as weightlifting for breathing muscles. These new breathing exercises have already been shown to increase heart health. Heart health is linked to brain health; if an intervention helps the heart, it is likely to also help the brain. It is currently unknown if breathing training can improve brain health in younger adults with obesity. The investigators will utilize the same 8-week program shown to improve heart health. Testing will be conducted before and after the breathing training. The first part of the study will determine if breathing exercises help brain health. Obesity also causes inflammation. This is measured via blood but affects the entire body. It is thought to cause some of the negative outcomes of obesity. By lowering inflammation, it is likely to improve overall health. Breathing exercises may reduce inflammation, but more research is required. The second part of this study will determine whether breathing exercises help reduce inflammation. This study will determine if brain health can be improved in adults with obesity. This could help 40% of American adults with obesity to live longer and healthier lives.
Eligibility 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.
Contact & Investigator
Joseph C Watso, PhD
PRINCIPAL INVESTIGATOR
Florida State University
Frequently Asked Questions
Who can join the NCT07406295 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07406295 currently recruiting?
Yes, NCT07406295 is actively recruiting participants. Contact the research team at tgb23@fsu.edu for enrollment information.
Where is the NCT07406295 trial being conducted?
This trial is being conducted at Tallahassee, United States.
Who is sponsoring the NCT07406295 clinical trial?
NCT07406295 is sponsored by Florida State University. The principal investigator is Joseph C Watso, PhD at Florida State University. The trial plans to enroll 30 participants.
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