[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540400":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":40,"responsibleParty":59,"collaborators":25,"id":62,"slug":25,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":25,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":25,"enrollmentInfo":70,"targetDuration":25,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":81,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"University of Sao Paulo General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Isolated Resistance Training Program Group","ACTIVE_COMPARATOR","Four sets of 10 knee extension repetitions will be performed with a 90-second rest interval between sets.",[13],"Other: Isolated Resistance Training Program",{"label":15,"type":16,"description":17,"interventionNames":18},"Neuromuscular Electrical Stimulation Group","EXPERIMENTAL","Neuromuscular electrical stimulation will be performed in muscles of the femoral quadriceps, simultaneously with the same resistance exercise program as the Isolated Resistance Training Program Group.",[19],"Other: Neuromuscular electrical stimulation",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Isolated Resistance Training Program","The hip range of motion (ROM) will be fixed at 45 degrees due to the limitation imposed by the femoral insertion of the intra-aortic balloon pump in both lower limbs to allow for a 45-degree knee extension ROM. Four sets of 10 knee extension repetitions will be performed with a 90-second rest interval between sets. The intensity (resistive load) will be set at 60% of the baseline load, calculated using the one-repetition maximum (1RM) test and increased by 10% after every 5 interventions.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Neuromuscular electrical stimulation","For NMES, two electrodes (area of 5 x 9 cm) will be positioned perpendicular to the muscles of the femoral quadriceps. The parameters of NMES will remain fixed throughout the study: pulsed, biphasic current, with a frequency of 35Hz, pulse width of 1000µs, on-time of 7 seconds (with 3 seconds of rise, 1 second of sustainment, and 3 seconds of descent), and off-time switched off. These settings allow the onset of NMES to be synchronous with the start and end of hip extension for simultaneous execution with resistance exercises and a total of 40 stimulations. The intensity will be gradually adjusted until evoked contractions of grade 4 to 5 (partial muscle recruitment and total muscle recruitment) or the maximum intensity tolerated by the patient is achieved.",[15],[31],{"name":32,"affiliation":33,"role":34},"Rafael M Ianotti, PT","Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo","PRINCIPAL_INVESTIGATOR",[36],{"name":32,"role":37,"phone":38,"phoneExt":25,"email":39},"CONTACT","+55 11 26615319","rafael.ianotti@hc.fm.usp.br",[41],{"facility":33,"status":42,"city":43,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","São Paulo","05403-000","Brazil","BR",{"type":48,"coordinates":49},"Point",[50,51],-46.63611,-23.5475,{"lat":51,"lon":50},[54,57],{"name":55,"role":56,"phone":25,"phoneExt":25,"email":25},"Silvia HG Lage, MD,PhD","SUB_INVESTIGATOR",{"name":58,"role":56,"phone":25,"phoneExt":25,"email":25},"Kelly CO Abud, PT,PhD",{"type":34,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Rafael M. Ianotti, P.T., Ph.D.","Clinical Research Coordinator - Physiotherapy Division - Heart Institute (InCor)","100540400",false,"NCT06316349","Isolated Resistance Training and Neuromuscular Electrical Stimulation in Patients With Femoral Intra Aortic Balloon Pump.","Isolated Resistance Training Program Versus Combined With Neuromuscular Electrical Stimulation for Femoral Quadriceps in Patients With Femoral Intra Aortic Balloon Pump: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Intra-aortic balloon pump (IABP) for more than 48 hours\n* Dobutamine ≤ 20 mcg\u002Fkg\u002Fmin\n* Norepinephrine ≤ 0.2 mcg\u002Fkg\u002Fmin (35)\n* Absence of device failures or bleeding in the last 24 hours\n* Mean arterial pressure (MAP) ≥ 60 mmHg and ≤ 120 mmHg\n* Heart rate (HR) ≥ 60 bpm and ≤ 120 bpm\n* Absence of neurological event with previous cognitive or motor deficit\n* Presence of untreated deep venous thrombosis\n* Absence of previous autoimmune diseases\n* Absence of previous rheumatic diseases\n\nProtocol Discontinuation Criteria:\n\n* Need for norepinephrine \\> 0.2 mcg\u002Fkg\u002Fmin\n* Acute arrhythmia of any etiology with hemodynamic instability\n* Hemodynamic instability: MAP \\\u003C 60 mmHg or \\>120 mmHg or HR \\\u003C 60 bpm or \\> 120 bpm\n* Occurrence of neurological event with cognitive or motor deficit\n\nExclusion Criteria:\n\n* Need for invasive mechanical ventilatory support\n* If the patient or responsible family member fails to sign or withdraws the informed consent","ALL","18 Years",{"count":71,"type":72},60,"ESTIMATED","INTERVENTIONAL",[75],"NA","The objective of this randomized clinical trial is to compare the effects of a standardized exercise program alone versus the same program combined with neuromuscular electrical stimulation in patients undergoing heart failure . The main questions it aims to answer are:\n\n* Assessing the ultrasonographic parameters: echo intensity (echogenicity), cross-sectional area, thickness, and pennation angle of the rectus femoris muscle in both lower limbs.\n* Evaluating the strength of the femoral quadriceps muscle\n* Evaluating the changes in the chronaxie of the rectus femoris muscle in both lower limbs.\n\nThe protocol will have a total duration of 32 days, with an initial intervention period of 18 days, followed by a 14-day follow-up period.",[78,79,80],"Heart Failure","Physical Therapy","Neuromuscular Electrical Stimulation",[78,82,83,80,84],"Intra-Aortic Ballom Pump","Acquired Muscle Weakness","Muscular echo intensity","2026-06-18",{"date":87,"type":88},"2026-06-23","ACTUAL",{"date":90,"type":88},"2024-06-18",{"date":92,"type":72},"2027-05-30",{"name":5,"class":6},1]