[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100468594":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":39,"centralContacts":44,"locations":54,"responsibleParty":75,"collaborators":77,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":31,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":31,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":103,"overallStatus":56,"whyStopped":31,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"University of Florida","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Daily IMT (dIMT)","EXPERIMENTAL","IMT (inspiratory muscle training) is a treatment strategy aimed to strengthen the muscles of inspiration, the diaphragm and external intercostals, by increasing their force-generating capacity. Participants in the dIMT (daily IMT) will complete daily inspiratory training exercises 2-4 weeks prior to surgery. A pressure threshold training device containing an adjustable-tension spring to provide resistance during inspiration will be used. Subjects will complete 5 sets of 5 maximal volume and speed breaths daily at a pressure 70% of MIP and will rest 1 minute between sets. They will be asked to keep a log to track their sessions to evaluate compliance with the exercise regimen.",[13],"Behavioral: Daily Inspiratory Muscle Training (dIMT)",{"label":15,"type":16,"description":17,"interventionNames":18},"Acute IMT (aIMT)","ACTIVE_COMPARATOR","Patients in the aIMT (acute IMT) experimental group will complete a single session of IMT guided by a physical therapist within 30 minutes of anesthesia induction in addition to standard of care. The adjustable pressure threshold training device to provide resistance during inspiration will be used. Subjects will complete 5 sets of 5 maximal volume and speed breaths, and rest 1 minute between sets. The training intensity will be set at 70% of MIP.",[19],"Behavioral: Acute Inspiratory Muscle Training (aIMT)",{"label":21,"type":16,"description":22,"interventionNames":23},"Standard of Care (SOC)","The SOC group will receive the usual surgical standard of care only.",[24],"Other: Standard of Care (SOC)",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"BEHAVIORAL","Daily Inspiratory Muscle Training (dIMT)","Daily IMT training sessions for 2-4 weeks prior to surgery",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Acute Inspiratory Muscle Training (aIMT)","A single session of IMT provided within 30 minutes prior to anesthesia induction.",[15],{"type":6,"name":21,"description":37,"armGroupLabels":38,"otherNames":31},"Standard of care only pre and post-operatively.",[21],[40],{"name":41,"affiliation":42,"role":43},"Barbara Smith, PhD","University of Florida, College of Public Health and Health Professions - Gainesville","PRINCIPAL_INVESTIGATOR",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":31,"email":49},"Maribel Z Ciampitti","CONTACT","904-891-6403","maribel.ciampitti@jax.ufl.edu",{"name":51,"role":47,"phone":52,"phoneExt":31,"email":53},"Tatiana Elias-Grajeda","(904) 244-9687","Tatiana.Elias-Grajeda@jax.ufl.edu",[55],{"facility":5,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"RECRUITING","Jacksonville","Florida","32209","United States","US",{"type":63,"coordinates":64},"Point",[65,66],-81.65565,30.33218,{"lat":66,"lon":65},[69,72],{"name":70,"role":47,"phone":71,"phoneExt":31,"email":49},"Maribel Ciampitti, MS","904-244-4690",{"name":73,"role":47,"phone":31,"phoneExt":31,"email":74},"Jennifer Bowman","Jennifer.Bowman@jax.ufl.edu",{"type":76,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[78],{"name":79,"class":80},"National Institute on Aging (NIA)","NIH","100468594","pre-operative-inspiratory-muscle-strength-training-in-total-joint-surgery-100468594",false,"NCT05381818","Pre-operative Inspiratory Muscle Strength Training in Total Joint Surgery","Preoperative Inspiratory Muscle Strength Training and Pulmonary Complications After Surgery","Inclusion Criteria:\n\n* 18 or older\n* History of current or previous tobacco use (including vaping containing nicotine products)\n* One or more risk factors for post operative pulmonary complications including history of current or previous tobacco use, a clinically diagnosed lung disease, shortness of breath with minimal exertion, FEV1 or FVC less than 80% than predicted or respiratory muscles strength below lower limit of normal for age and sex.\n* History of smoking related lung disease\n* Projected surgical time \\> 30 minutes\n* Ability to follow instructions to complete IMT exercises\n* Ability to communicate adverse effects such as pain or fatigue or the need for assistance\n\nExclusion Criteria:\n\n* American Society of Anesthesiologists physical status classification of 4 or greater .\n* Recent history of acute pneumonia or lower respiratory infection in the previous two weeks requiring acute corticosteroid or antibiotic medication,\n* Preoperative dependence on continuous supplemental oxygen dependence.\n* Preoperative dependence on positive pressure breathing support while awake and upright (night time CPAP permitted),\n* Diagnosis of a neurologic condition (i.e. MS, ALS, Parkinson's, stroke),\n* Participating in a pulmonary rehabilitation program\n* Severe obstructive pulmonary disease (Classification of Global Initiative for Chronic Obstructive Lung Disease (GOLD) 3 or higher, indicating FEV1\\\u003C50% predicted.\n* Patients with an infectious disease requiring isolation (i.e. COVID-19).","ALL","18 Years","100 Years",{"count":92,"type":93},36,"ESTIMATED","INTERVENTIONAL",[96],"NA","The purpose of this research study is to evaluate effects of respiratory strengthening exercises on breathing function, in people who have orthopedic surgery. It is known that breathing function decreases for a few days after surgery. in In this study, we want to see if exercising before surgery strengthens the breathing muscles and improves recovery after surgery.",[99,100,101,102],"Arthropathy of Knee","Arthropathy of Hip","Lower Extremity Fracture","Orthopedic Disorder",[104,105,106],"Inspiratory muscle training","Pulmonary complications","Total joint replacement","2026-05-13",{"date":109,"type":110},"2026-05-15","ACTUAL",{"date":112,"type":110},"2022-07-01",{"date":114,"type":93},"2026-12",{"name":5,"class":6},1]