[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659355":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":42,"studyPopulation":11,"armGroups":43,"interventions":56,"overallOfficials":66,"centralContacts":70,"locations":78,"responsibleParty":90,"collaborators":11,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":11,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":11,"enrollmentInfo":101,"targetDuration":11,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":11,"overallStatus":112,"whyStopped":11,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"NYU Langone Health","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":11},[9,13,15],{"measure":10,"description":11,"timeFrame":12},"Percentage of completed training session",null,"Final Visit (up to 6 months)",{"measure":14,"description":11,"timeFrame":12},"Time required to administer and monitor IMT sessions",{"measure":16,"description":11,"timeFrame":12},"Number of left ventricular assist device (LVAD) implantation or heart transplantation",[18,22,26,28,31,34],{"measure":19,"description":20,"timeFrame":21},"Change in Six-Minute Walk Test (6MWT) in meters","The 6MWT measures the total distance in meters that a person can walk on a flat, hard surface over a period of 6 minutes to evaluate functional exercise capacity. The primary score is the total distance walked in meters. Healthy adults typically walk between 400 and 700 meters.","Baseline, Post-operative",{"measure":23,"description":24,"timeFrame":25},"Change in Borg Category-Ratio (CR) 10 Dyspnea Scale at rest","The Borg CR10 Dyspnea Scale is a numerical rating tool that patients use to report how difficult their breathing feels at a specific moment. The scale ranges from 0 (Nothing at all) to 10 (Maximal (the worst breathing difficulty the person has ever experienced)).","Baseline, Final Visit (up to 6 months)",{"measure":27,"description":24,"timeFrame":25},"Change in Borg CR10 Dyspnea Scale following exertion",{"measure":29,"description":30,"timeFrame":25},"Change in maximal inspiratory pressure (MIP)","MIP measures the strength of your breathing muscles, like the diaphragm and ribs. MIP values are recorded in centimeters of water (cmH₂O) as negative numbers. Note: Because it measures negative pressure, a larger negative number means stronger muscles",{"measure":32,"description":11,"timeFrame":33},"Post-operative ICU length of stay (LOS)","From post-operative admission until discharge (up to 4 weeks)",{"measure":35,"description":11,"timeFrame":33},"Post-operative hospital LOS",{"allocation":37,"interventionModel":38,"interventionModelDescription":11,"primaryPurpose":39,"observationalModel":11,"timePerspective":11,"maskingInfo":40},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":41,"maskingDescription":11,"whoMasked":11},"NONE","This randomized prospective, pilot study will enroll 30 adults hospitalized with heart failure and awaiting advanced therapies (LVAD or Heart Transplant). One group will receive usual care PT while the intervention group will be instructed in the use of an inspiratory muscle trainer to be performed at least 5 days a week with the supervision of a physical therapist. Both groups will undergo testing of Maximal Inspiratory Pressure (MIP) using the POWERbreathe® Inspiratory Muscle Trainer. Data collection will include Maximal Inspiratory Pressure (MIP), 6-minute walk test (6MWT) distance, dyspnea at rest and with exertion, at the start, every two weeks from start, and end of study period.",[44,51],{"label":45,"type":46,"description":47,"interventionNames":48},"Inspiratory Muscle Training (IMT) + Usual Care","EXPERIMENTAL","Participants will perform IMT 1 set of 30 breaths at 50% MIP, 5 days\u002Fweek, in addition to usual care physical therapy.",[49,50],"Device: POWERbreathe KH2","Other: Usual Care",{"label":52,"type":53,"description":54,"interventionNames":55},"Usual Care Only","ACTIVE_COMPARATOR","Participants in this arm will receive usual care physical therapy only.",[50],[57,62],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":11},"DEVICE","POWERbreathe KH2","IMT is a noninvasive, exercise-based intervention designed to improve inspiratory muscle strength and endurance by providing a resistive load during inhalation.",[45],{"type":6,"name":63,"description":64,"armGroupLabels":65,"otherNames":11},"Usual Care","Usual care physical therapy may include functional mobility training, therapeutic activities, gait training, and therapeutic exercise, delivered according to the treating physical therapist's clinical judgment and the patient's medical status.",[45,52],[67],{"name":68,"affiliation":5,"role":69},"Angela Stolfi, PT, DPT","PRINCIPAL_INVESTIGATOR",[71,75],{"name":68,"role":72,"phone":73,"phoneExt":11,"email":74},"CONTACT","212-263-6074","Angela.stolfi@nyulangone.org",{"name":76,"role":72,"phone":73,"phoneExt":11,"email":77},"Corinne Natale","Corinne.natale@nyulangone.org",[79],{"facility":5,"status":11,"city":80,"state":80,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":11},"New York","10016","United States","US",{"type":85,"coordinates":86},"Point",[87,88],-74.00597,40.71427,{"lat":88,"lon":87},{"type":91,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100659355","inspiratory-muscle-training-in-hospitalized-patients-with-heart-failure-awaiting-advanced-therapies-a-single-center-pilot-feasibility-study-100659355",false,"NCT07862738","Inspiratory Muscle Training in Hospitalized Patients With Heart Failure Awaiting Advanced Therapies: a Single-center Pilot Feasibility Study","Comparing the Addition of Inspiratory Muscle Training (IMT) to Usual Care Physical Therapy in Hospitalized Patients With Heart Failure Awaiting Advanced Therapies: a Single-center Pilot Feasibility Study","Inclusion Criteria:\n\n1. 18 years old or older\n2. Able to provide consent and willing to participate in study procedures\n3. Currently hospitalized awaiting advanced therapies (LVAD or heart transplant)\n4. Diagnosed with NYHA class III or IV heart failure\n5. Able to follow instructions including the use of the Borg Dyspnea scale\n6. Physically able to independently hold and use the IMT\n7. Patients will undergo screening with or without active PT orders. To be enrolled in the study, patient must have an active physical therapy order. . If no active order exists, one will be requested from medical team following the screening and prior to enrollment.\n8. Participants must meet institutional criteria for participation in physical therapy and mobility activities prior to enrollment and before each IMT session. Medical stability may include:\n\n   * Mean arterial pressure (MAP) ≥ 60 mmHg and ≤ 120 mmHg\n   * Resting heart rate between 40 and 140 beats per minute\n   * No evidence of active myocardial ischemia or unstable angina\n   * No uncontrolled atrial or ventricular arrhythmias\n   * No escalating vasopressor or inotropic support at time of intervention\n   * Oxygen saturation ≥ 94% on current oxygen support\n   * Respiratory rate between 8 and 35 breaths per minute\n   * Ability to follow simple commands and participate in study procedures\n   * No acute neurologic, respiratory, or hemodynamic deterioration requiring immediate escalation of care\n   * Clearance by the treating medical team to participate in rehabilitation activities\n\nExclusion Criteria:\n\n1. Patients discharged from the hospital to await advanced therapies (LVAD or heart transplant)\n2. Patients with an expectedpreoperative inpatient hospital stay of less than 10 days, based onreview of clinical status, treatment plan, and timing of expected surgery\n3. Patients with acute pneumothorax\n4. Presence of acute rib fracture(s)\n5. Patients with acute cerebrovascular accident\n6. Untreated hypertension, defined as systolic blood pressure consistently \\>140 mmHg or diastolic blood pressure consistently \\>90 mmHg in the absence of antihypertensive therapy.\n7. Acute delirium\n8. Perforated tympanic membrane\n9. Hemodynamic instability\n10. Abdominal surgery during present admission\n11. Patients with planned multiple organ transplant (e.g. heart and kidney, heart and lung)\n12. Patients currently requiring mechanical ventilatory support\n13. A burst eardrum that has not fully healed, or any other condition of the eardrum\n14. Patients with asthma who suffer from frequent severe exacerbations\n15. Patients with marked elevated left ventricular end-diastolic volume and pressure\n16. Patients with worsening heart failure signs and symptoms after IMT\n17. If you have suffered from or are likely to suffer from costochondritis","ALL","18 Years",{"count":102,"type":103},30,"ESTIMATED","INTERVENTIONAL",[106],"NA","The primary objective of this study is to evaluate the feasibility and safety of inspiratory muscle training (IMT) when implemented as part of routine inpatient physical therapy care in patients undergoing evaluation for advanced heart therapies. The secondary aim is to determine if IMT improves 6-minute walk test (6MWT), dyspnea, Maximal Inspiratory Pressure (MIP) pre-operatively. Thirdly, to determine if IMT decreases ICU and hospital length of stay post-operatively.",[109,110,111],"Heart Failure","Heart Failure New York Heart Association Class III","Heart Failure New York Heart Association Class IV","NOT_YET_RECRUITING","2026-10-02",{"date":115,"type":116},"2026-10-07","ACTUAL",{"date":118,"type":103},"2026-11-10",{"date":120,"type":103},"2027-11-10",{"name":5,"class":6},1]