Respiratory Muscle Training to Improve Cerebrovascular and Immune Function
Recruiting · NCT07406295 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 is running
1 location listed across 1 US state.
- Florida State University - Tallahassee, Florida, United States