[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609605":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":53,"centralContacts":57,"locations":63,"responsibleParty":83,"collaborators":43,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":43,"eligibilityCriteria":92,"healthyVolunteers":93,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":43,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":43,"overallStatus":65,"whyStopped":43,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Embry-Riddle Aeronautical University","OTHER",[8,15,21,27],{"label":9,"type":10,"description":11,"interventionNames":12},"RMT + Nitrate Supplementation","EXPERIMENTAL","Participants complete a multi-week respiratory muscle training (RMT) program using a handheld breathing device that provides progressive inspiratory and expiratory resistance. Participants also consume a daily standardized dose of beetroot juice concentrate containing dietary nitrate. This combination is expected to enhance breathing muscle strength, vascular function, and exercise tolerance under simulated altitude.",[13,14],"Device: Respiratory Muscle Training (RMT)","Dietary Supplement: Dietary Supplement: Beetroot Juice Concentrate",{"label":16,"type":17,"description":18,"interventionNames":19},"Respiratory Muscle Training + Placebo","PLACEBO_COMPARATOR","Participants perform the same RMT program as in Arm 1 but consume a placebo beverage that is visually and taste-matched to the nitrate drink but contains no active nitrate. This group allows assessment of the independent effects of respiratory muscle training.",[13,20],"Dietary Supplement: placebo beverage",{"label":22,"type":23,"description":24,"interventionNames":25},"Sham Respiratory Muscle Training + Nitrate Supplementation","SHAM_COMPARATOR","Participants perform sham RMT with a very low resistance load that does not provide a training stimulus, while consuming the active nitrate beverage daily. This group isolates the independent effect of nitrate supplementation on exercise tolerance under hypoxic conditions.",[26,14],"Device: Sham Respiratory Muscle Training",{"label":28,"type":17,"description":29,"interventionNames":30},"Sham Respiratory Muscle Training + Placebo","Participants complete sham RMT with minimal breathing resistance and consume a placebo beverage identical in appearance and flavor to the nitrate supplement but containing no active ingredients. This serves as the control condition for comparison with all other intervention groups.",[26,20],[32,39,44,49],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"DEVICE","Respiratory Muscle Training (RMT)","Participants perform supervised respiratory muscle training (RMT) using a handheld resistive breathing device designed to strengthen the inspiratory and expiratory muscles. Training sessions are conducted 5 days per week for approximately 4-6 weeks. Each session includes a series of resisted breathing maneuvers with progressively increased load as tolerated. The device is calibrated to maintain a constant pressure threshold to ensure consistent training intensity.",[9,16],[38],"Inspiratory Muscle Training",{"type":33,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"Sham Respiratory Muscle Training","Participants use an identical handheld breathing device with minimal resistance, providing no meaningful training stimulus. The training schedule and session duration match those of the active RMT group to maintain participant blinding.",[22,28],null,{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":43},"DIETARY_SUPPLEMENT","Dietary Supplement: Beetroot Juice Concentrate","Participants consume a standardized dose of concentrated beetroot juice daily for the duration of the training period (approximately 4-6 weeks). The supplement provides a fixed quantity of dietary nitrate known to enhance nitric oxide availability and support vascular and metabolic function during exercise.",[9,22],{"type":45,"name":50,"description":51,"armGroupLabels":52,"otherNames":43},"placebo beverage","Participants consume a placebo beverage identical in color, taste, and appearance to the nitrate supplement but containing no active nitrate. The beverage is consumed daily following the same schedule as the active supplement.",[16,28],[54],{"name":55,"affiliation":5,"role":56},"Scott K Ferguson, Ph.D.","PRINCIPAL_INVESTIGATOR",[58],{"name":59,"role":60,"phone":61,"phoneExt":43,"email":62},"Scott Ferguson K Ferguson, Ph.D.","CONTACT","386-226-7381","ferguss8@erau.edu",[64],{"facility":5,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"RECRUITING","Daytona Beach","Florida","32114","United States","US",{"type":72,"coordinates":73},"Point",[74,75],-81.02283,29.21081,{"lat":75,"lon":74},[78,82],{"name":79,"role":60,"phone":80,"phoneExt":43,"email":81},"Teri Gabriel","1386-226-7179","teri.gabriel@erau.edu",{"name":55,"role":56,"phone":43,"phoneExt":43,"email":43},{"type":56,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"Scott Kohman Ferguson","Assistant Professor","100609605","effects-of-breathing-training-and-nitrate-on-exercise-at-simulated-altitude-100609605",false,"NCT07216755","Effects of Breathing Training and Nitrate on Exercise at Simulated Altitude","Impact of Respiratory Muscle Training and Nitrate Therapy on Exercise Tolerance in Simulated Altitude","Inclusion Criteria:\n\n* Healthy adults between 18 and 40 years old.\n\nRecreationally active (performing ≥3 hours of structured physical activity per week).\n\nNon-smokers for at least the past 6 months.\n\nFree from any known cardiovascular, pulmonary, metabolic, or neuromuscular disease as determined by health screening questionnaire and medical history.\n\nAble to perform cycle ergometer exercise to volitional fatigue.\n\nWilling to abstain from high-nitrate foods and supplements (e.g., beets, spinach, arugula) for 48 hours prior to each testing session.\n\nAble and willing to provide written informed consent and comply with all study procedures.\n\nExclusion Criteria:\n\n* Diagnosis of or history of heart disease, hypertension, diabetes, or chronic respiratory disorders (e.g., asthma, COPD).\n\nCurrent use of medications or supplements known to affect cardiovascular, metabolic, or respiratory function (e.g., beta-blockers, nitrates, stimulants).\n\nSmoking, vaping, or tobacco use within the past 6 months.\n\nKnown allergy or intolerance to beetroot products or nitrates.\n\nParticipation in another interventional research study within the past 30 days.\n\nPregnant or breastfeeding women.\n\nAny orthopedic or musculoskeletal limitation preventing safe exercise testing.\n\nFailure to meet inclusion criteria or inability to complete familiarization and baseline testing.",true,"ALL","18 Years","40 Years",{"count":98,"type":99},80,"ESTIMATED","INTERVENTIONAL",[102],"NA","This study investigates whether respiratory muscle training (RMT) and dietary nitrate supplementation can improve exercise tolerance under simulated moderate altitude conditions. Exposure to reduced oxygen availability at altitude places additional strain on the cardiovascular and respiratory systems, which may limit endurance performance. By combining RMT-designed to strengthen the muscles involved in breathing-with nitrate therapy, which enhances nitric oxide availability and vascular function, this study aims to determine whether these interventions independently or synergistically improve oxygen delivery, reduce physiological strain, and enhance exercise performance. The findings will help identify non-pharmacological strategies to improve physical performance and tolerance to hypoxia in both clinical and operational environments.",[105,106,107,108,109,110,111,38],"Healthy Adults","Mechanical Ventilation Dependence","Hypoxia","Exercise Training","Exercise Intolerance","Dietary Supplement","Nitrate Supplementation","2025-10-13",{"date":114,"type":115},"2025-10-15","ACTUAL",{"date":117,"type":115},"2025-09-01",{"date":119,"type":99},"2028-08-31",{"name":5,"class":6},1]