Respiratory Muscle Training to Improve Cerebrovascular and Immune Function

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorFlorida State University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: High intensity inspiratory muscle strength trainingActive comparator 1 intervention
Group B: Low intensity inspiratory muscle strength trainingSham comparator 1 intervention

Trial outcomes

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

Time frame
Up to 9 weeks

Secondary outcomes

1

Change in immune cell androgenic sensitivity

Isolate peripheral blood mononuclear cells and expose them to catecholamines to determine concentration of cAMP production.

Time frame
Up to 9 weeks
2

Change in dynamic cerebral autoregulation phase

Calculated from middle cerebral artery blood velocity signal using transfer function analysis

Time frame
Up to 9 weeks
3

Change in total resting brain blood flow

Total brain blood flow measured in the internal carotid and vertebral arteries at rest via ultrasound

Time frame
Up to 9 weeks
4

Change in dynamic cerebral autoregulation gain

Calculated from middle cerebral artery blood velocity signal using transfer function analysis

Time frame
Up to 9 weeks

Other outcomes

Sponsors and contacts

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