Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 5:52 AM
Study NCT ID:
NCT07406295
Status:
RECRUITING
Last Update Posted:
2026-02-13
First Post:
2026-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Respiratory Muscle Training to Improve Cerebrovascular and Immune Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There is high intensity training group and low intensity (sham) group. Randomization is 2:1 for high to low intensity groups.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-11', 'studyFirstSubmitDate': '2026-02-06', 'studyFirstSubmitQcDate': '2026-02-06', 'lastUpdatePostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in middle cerebral artery blood velocity reactivity to hypercapnia', 'timeFrame': 'Up to 9 weeks', 'description': 'Middle cerebral artery blood velocity will be measured via transcranial Doppler ultrasound'}], 'secondaryOutcomes': [{'measure': 'Change in immune cell androgenic sensitivity', 'timeFrame': 'Up to 9 weeks', 'description': 'Isolate peripheral blood mononuclear cells and expose them to catecholamines to determine concentration of cAMP production.'}, {'measure': 'Change in dynamic cerebral autoregulation phase', 'timeFrame': 'Up to 9 weeks', 'description': 'Calculated from middle cerebral artery blood velocity signal using transfer function analysis'}, {'measure': 'Change in total resting brain blood flow', 'timeFrame': 'Up to 9 weeks', 'description': 'Total brain blood flow measured in the internal carotid and vertebral arteries at rest via ultrasound'}, {'measure': 'Change in dynamic cerebral autoregulation gain', 'timeFrame': 'Up to 9 weeks', 'description': 'Calculated from middle cerebral artery blood velocity signal using transfer function analysis'}, {'measure': 'Middle cerebral artery blood velocity pulsatility index', 'timeFrame': 'Up to 9 weeks', 'description': 'Calculated from middle cerebral artery blood velocity signal'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Transcranial Doppler', 'Inspiratory Muscle Strength Training', 'Cerebrovascular Reactivity'], 'conditions': ['Obesity', 'Cerebrovascular Function', 'Immune Cells Activity']}, 'descriptionModule': {'briefSummary': '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.\n\nThese 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.\n\nObesity 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.', 'detailedDescription': "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.\n\nGiven 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.\n\nAim 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.\n\nAim 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index greater than or equal to 30 kg/m2\n* Waist circumference greater or equal to 88 cm for females and greater than or equal to 102 cm for males\n\nExclusion Criteria:\n\n* Not weight stable (\\<5% change in body mass over the past six months)\n* Overt cardiovascular, neurological, renal, liver, and/or metabolic illness (e.g., diabetes mellitus)\n* Current, or history of uncontrolled, Stage 2 hypertension (blood pressure \\>140 / 90 mmHg; anti-hypertensive medications are permitted)\n* Diagnosed obstructive sleep apnea\n* Previous bariatric surgery\n* Diagnosis or signs (e.g., values below the lower limit of normal) of overt airway disease(s)\n* Current or recent (regular use within the past 6 months) use of tobacco or nicotine products (e.g., cigarettes, vaping)\n* Pregnant (self-reported and confirmed via urine pregnancy test), lactating (self-reported), or post-menopausal (self-reported) females\n* Prisoners\n\nPer the POWERbreathe® company:\n\n* Patients who have undergone recent abdominal surgery and those with abdominal hernia.\n* Asthma patients who have a very low symptom perception and suffer from frequent, severe exacerbations or with an abnormally low perception of dyspnea.\n* If a patient is suffering from a ruptured eardrum or any other condition of the ear.\n* Patients with marked elevated left ventricular end-diastolic volume and pressure.\n* 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.'}, 'identificationModule': {'nctId': 'NCT07406295', 'briefTitle': 'Respiratory Muscle Training to Improve Cerebrovascular and Immune Function', 'organization': {'class': 'OTHER', 'fullName': 'Florida State University'}, 'officialTitle': 'Novel Respiratory Muscle Training for Improving Cerebrovascular Function and Immune Status in Adults With Obesity', 'orgStudyIdInfo': {'id': 'STUDY00006611'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High intensity inspiratory muscle strength training', 'description': '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.', 'interventionNames': ['Device: High intensity inspiratory muscle strength training']}, {'type': 'SHAM_COMPARATOR', 'label': 'Low intensity inspiratory muscle strength training', 'description': '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.', 'interventionNames': ['Device: Low intensity']}], 'interventions': [{'name': 'High intensity inspiratory muscle strength training', 'type': 'DEVICE', 'description': 'This intervention will aim to increase inspiratory strength in adults with obesity to improve cerebrovascular function and immune status.', 'armGroupLabels': ['High intensity inspiratory muscle strength training']}, {'name': 'Low intensity', 'type': 'DEVICE', 'description': 'Very-low-resistance inspiratory muscle strength training', 'armGroupLabels': ['Low intensity inspiratory muscle strength training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32303', 'city': 'Tallahassee', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Florida State University Facilities Specialist', 'role': 'CONTACT', 'email': 'jrm10@fsu.edu', 'phone': '8506447764'}], 'facility': 'Florida State University', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}], 'centralContacts': [{'name': 'Thomas Bissen, MS', 'role': 'CONTACT', 'email': 'tgb23@fsu.edu', 'phone': '9522121833'}], 'overallOfficials': [{'name': 'Joseph C Watso, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Florida State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Florida State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Joseph Watso', 'investigatorAffiliation': 'Florida State University'}}}}