Respiratory Muscle Training to Improve Cerebrovascular and Immune Function

Part of paid clinical trials in Tallahassee, Florida.

Sponsor
Florida State University
Study ID
NCT07406295
Status
Recruiting

Conditions

  • Cerebrovascular Function
  • Immune Cells Activity
  • Obesity

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

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.
  • Low intensity — DEVICE
    Very-low-resistance inspiratory muscle strength training

Study Details

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.

Key Dates

Start date
Jan 27, 2026
Status verified
Feb 2026
Primary completion
Dec 1, 2027
Completion
May 1, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • 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.
  • 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.

Primary Outcome Measure

Change in middle cerebral artery blood velocity reactivity to hypercapnia [ Time Frame: Up to 9 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Florida State UniversityTallahasseeFlorida32303
Florida State University Facilities Specialist
8506447764

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