Respiratory Muscle Training to Improve Cerebrovascular and Immune Function

NCT07406295 | Recruiting FDA Device

• 1 other identifier: STUDY00006611
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Cerebrovascular Function; Immune Cells Activity

Keywords

Transcranial Doppler; Inspiratory Muscle Strength Training; Cerebrovascular Reactivity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in immune cell androgenic sensitivity

  Up to 9 weeks

• Change in dynamic cerebral autoregulation phase

  Up to 9 weeks

• Change in total resting brain blood flow

  Up to 9 weeks

• Change in dynamic cerebral autoregulation gain

  Up to 9 weeks

• Middle cerebral artery blood velocity pulsatility index

  Up to 9 weeks

Study Arms (2)

High intensity inspiratory muscle strength training

ACTIVE COMPARATOR

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

Low intensity inspiratory muscle strength training

SHAM COMPARATOR

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

Interventions

High intensity inspiratory muscle strength training DEVICE

This intervention will aim to increase inspiratory strength in adults with obesity to improve cerebrovascular function and immune status.

High intensity inspiratory muscle strength training

Low intensity DEVICE

Very-low-resistance inspiratory muscle strength training

Low intensity inspiratory muscle strength training

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Florida State University

Tallahassee, Florida, 32303, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joseph C Watso, PhD

  Florida State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Bissen, MS

CONTACT

9522121833; tgb23@fsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: There is high intensity training group and low intensity (sham) group. Randomization is 2:1 for high to low intensity groups.

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 12, 2026
• Study Start: January 27, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: June 26, 2026

Record last verified: 2026-06

Locations

US (1)