protocolSection identificationModule nctId: NCT06316349, orgStudyIdInfo id: CAAE: 75727323.3.0000.0068, briefTitle: Isolated Resistance Training and Neuromuscular Electrical Stimulation in Patients With Femoral Intra Aortic Balloon Pump., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2025-01-10, completionDateStruct date: 2025-10-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: University of Sao Paulo General Hospital, class: OTHER, descriptionModule briefSummary: 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:* Assessing the ultrasonographic parameters: echo intensity (echogenicity), cross-sectional area, thickness, and pennation angle of the rectus femoris muscle in both lower limbs.* Evaluating the strength of the femoral quadriceps muscle* Evaluating the changes in the chronaxie of the rectus femoris muscle in both lower limbs The protocol will have a total duration of 35 days, with an initial intervention period of 21 days (5 days per week), followed by a 14-day follow-up period., conditionsModule conditions: Heart Failure, conditions: Physical Therapy, conditions: Neuromuscular Electrical Stimulation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Rondomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The researcher responsible for conducting the ultrasonographic measurements will be blinded regarding the randomization and allocation groups., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 68, type: ESTIMATED, armsInterventionsModule interventions name: Isolated Resistance Training Program, interventions name: Neuromuscular electrical stimulation, outcomesModule primaryOutcomes measure: To investigate echo intensity of the rectus femoris muscle, secondaryOutcomes measure: To investigate cross-sectional area of the rectus femoris muscle, secondaryOutcomes measure: To investigate pennation angle of the rectus femoris muscle, secondaryOutcomes measure: To investigate changes in quadriceps femoral muscle strength, secondaryOutcomes measure: To investigate changes in arterial blood pressure during the protocol, secondaryOutcomes measure: To investigate changes in heart rate during the protocol, secondaryOutcomes measure: To investigate changes in peripheral oxygen saturation during the protocol, secondaryOutcomes measure: To investigate changes in the veno-arterial difference in carbon dioxide partial pressure, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, city: Sao Paulo, zip: 05403-000, country: Brazil, contacts name: Silvia HG Lage, MD,PhD, role: SUB_INVESTIGATOR, contacts name: Kelly CO Abud, PT,PhD, role: SUB_INVESTIGATOR, geoPoint lat: -23.5475, lon: -46.63611, hasResults: False