Respiratory Muscle Training to Improve Cerebrovascular and Immune Function

Novel Respiratory Muscle Training for Improving Cerebrovascular Function and Immune Status in Adults With Obesity

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Immune Cells Activity; Cerebrovascular Function
• Intervention / Treatment: Device: High intensity inspiratory muscle strength training; Device: Low intensity

Detailed Description

Obesity, a growing global epidemic in America, is linked to cerebrovascular dysfunction and increases the risk of stroke, the nation's fourth leading cause of death. Cerebrovascular dysfunction is defined by impaired cerebrovascular reactivity and reduced cerebral autoregulation. Inspiratory muscle strength training (IMST) has proven to be a time-efficient, effective, low-cost, and highly feasible intervention for improving peripheral vascular function.

Given the link between the peripheral vasculature and cerebrovasculature systems, it is highly plausible that IMST may improve cerebrovasculature function. Emerging data show that in adults with elevated blood pressure, IMST improves cerebrovascular function. Thus, the study team will examine whether 8 weeks of IMST improves cerebrovascular function in otherwise healthy young adults with obesity.

Aim 1 will test the hypothesis that IMST will favorably increase cerebrovascular reactivity and improve cerebral autoregulation. Obesity-induced cerebrovascular dysfunction may be driven by chronic low-grade inflammation resulting from excessive sympathetic signaling. Additionally, inflammation is associated with reduced immune function. In adults with obesity, the systemic immune-inflammation index is elevated and positively associated with all-cause mortality. Emerging studies show IMST has the potential to reduce sympathetic activity and improve inflammation status.

Aim 2 will test the hypothesis that IMST will reduce inflammation and improve immune function in otherwise healthy young adults with obesity. It is hypothesized that IMST will improve cerebrovascular reactivity and autoregulation, suggesting improved cerebrovascular health. Additionally, IMST will reduce the systemic immune-inflammation index and improve immune function in otherwise healthy young adults with obesity. This project explores the potential of IMST as a time-efficient and cost-effective intervention to improve cerebrovascular function and mitigate inflammation-related immune dysfunction in adults with obesity, potentially enhancing healthspan and lifespan. These findings could inform public health initiatives targeting approximately 40% of American adults with obesity, improving overall cerebrovascular function in the short term and reducing stroke incidence later in life.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas Bissen, MS; Phone Number: 9522121833; Email: tgb23@fsu.edu

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32303
      • Recruiting
      • Florida State University
      • Contact: Florida State University Facilities Specialist; Phone Number: 8506447764; Email: jrm10@fsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: High intensity inspiratory muscle strength training; Participants will perform high-resistance inspiratory muscle strength training on a daily basis for eight weeks using a handheld device that produces resistance that increases the effort of breathing in.	Device: High intensity inspiratory muscle strength training; This intervention will aim to increase inspiratory strength in adults with obesity to improve cerebrovascular function and immune status.
Sham Comparator: Low intensity inspiratory muscle strength training; Participants will perform very-low-resistance inspiratory muscle strength training on a daily basis for eight weeks using a handheld device that produces resistance that increases the effort of breathing in.	Device: Low intensity; Very-low-resistance inspiratory muscle strength training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in middle cerebral artery blood velocity reactivity to hypercapnia	Middle cerebral artery blood velocity will be measured via transcranial Doppler ultrasound	Up to 9 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in dynamic cerebral autoregulation phase	Calculated from middle cerebral artery blood velocity signal using transfer function analysis	Up to 9 weeks
Change in dynamic cerebral autoregulation gain	Calculated from middle cerebral artery blood velocity signal using transfer function analysis	Up to 9 weeks
Change in total resting brain blood flow	Total brain blood flow measured in the internal carotid and vertebral arteries at rest via ultrasound	Up to 9 weeks
Middle cerebral artery blood velocity pulsatility index	Calculated from middle cerebral artery blood velocity signal	Up to 9 weeks
Change in immune cell androgenic sensitivity	Isolate peripheral blood mononuclear cells and expose them to catecholamines to determine concentration of cAMP production.	Up to 9 weeks

Collaborators and Investigators

• Sponsor: Florida State University
• Investigators: Principal Investigator: Joseph C Watso, PhD, Florida State University

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: February 6, 2026
• First Submitted That Met QC Criteria: February 6, 2026
• First Posted (Actual): February 12, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Inspiratory Muscle Strength Training; Transcranial Doppler; Cerebrovascular Reactivity
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity
• Other Study ID Numbers: STUDY00006611

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No