ObesityNCT07406295
Respiratory Muscle Training to Improve Cerebrovascular and Immune Function
A study testing High intensity inspiratory muscle strength training and Low intensity in people with Obesity and Cerebrovascular Function, run by Florida State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Obesity, Cerebrovascular Function, Immune Cells Activity
- What is being tested?
- High intensity inspiratory muscle strength training and Low intensity
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2026to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Florida State University
Tallahassee, Florida, 32303
Florida State University Facilities Specialist, 8506447764, jrm10@fsu.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity, Cerebrovascular Function, Immune Cells Activity
- Being tested
- High intensity inspiratory muscle strength training, Low intensity
- Keywords
- Transcranial Doppler, Inspiratory Muscle Strength Training, Cerebrovascular Reactivity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity inspiratory muscle strength trainingDevice
This intervention will aim to increase inspiratory strength in adults with obesity to improve cerebrovascular function and immune status.
Low intensityDevice
Very-low-resistance inspiratory muscle strength training
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Low intensity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in middle cerebral artery blood velocity reactivity to hypercapnia
Middle cerebral artery blood velocity will be measured via transcranial Doppler ultrasound
Measured: Up to 9 weeks
Secondary outcomes (5)
Change in immune cell androgenic sensitivity
Isolate peripheral blood mononuclear cells and expose them to catecholamines to determine concentration of cAMP production.
Measured: Up to 9 weeks
Change in dynamic cerebral autoregulation phase
Calculated from middle cerebral artery blood velocity signal using transfer function analysis
Measured: 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
Measured: Up to 9 weeks
Change in dynamic cerebral autoregulation gain
Calculated from middle cerebral artery blood velocity signal using transfer function analysis
Measured: Up to 9 weeks
Middle cerebral artery blood velocity pulsatility index
Calculated from middle cerebral artery blood velocity signal
Measured: Up to 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start27 Jan 2026
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There is high intensity training group and low intensity (sham) group. Randomization is 2:1 for high to low intensity groups.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Watso, Florida State University
- Investigators
- Joseph C Watso, PhD, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07406295
- Sponsor's protocol ID
- STUDY00006611
- Status last verified
- Oct 2026
- First submitted
- 6 Feb 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Respiratory Muscle Training for Improving Cerebrovascular Function and Immune Status in Adults With Obesity
- ClinicalTrials.gov ID
- NCT07406295
- Acronym / sponsor ID
- STUDY00006611
- Conditions
- Obesity, Cerebrovascular Function, Immune Cells Activity
- Keywords
- Transcranial Doppler, Inspiratory Muscle Strength Training, Cerebrovascular Reactivity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 27 Jan 2026 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- There is high intensity training group and low intensity (sham) group. Randomization is 2:1 for high to low intensity groups.
| Arm | Type | Receives |
|---|---|---|
| High intensity inspiratory muscle strength training | Active comparator | Device: High intensity inspiratory muscle strength trainingParticipants 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. |
| Low intensity inspiratory muscle strength training | Sham comparator | Device: Low intensityParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High intensity inspiratory muscle strength trainingThis intervention will aim to increase inspiratory strength in adults with obesity to improve cerebrovascular function and immune status. | Device | High intensity inspiratory muscle strength training |
| Low intensityVery-low-resistance inspiratory muscle strength training | Device | Low intensity inspiratory muscle strength training |
Primary outcome
Change in middle cerebral artery blood velocity reactivity to hypercapnia
Time frame: Up to 9 weeks
Middle cerebral artery blood velocity will be measured via transcranial Doppler ultrasound
5 secondary outcomes
Change in immune cell androgenic sensitivity
Time frame: Up to 9 weeks
Change in dynamic cerebral autoregulation phase
Time frame: Up to 9 weeks
Change in total resting brain blood flow
Time frame: Up to 9 weeks
Change in dynamic cerebral autoregulation gain
Time frame: Up to 9 weeks
Middle cerebral artery blood velocity pulsatility index
Time frame: Up to 9 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joseph C Watso, PhD principal investigator
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity inspiratory muscle strength training and Low intensity in people with Obesity and Cerebrovascular Function, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Bissen, MS (9522121833, tgb23@fsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in middle cerebral artery blood velocity reactivity to hypercapnia (time frame: Up to 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.