RecruitingNot ApplicableNCT06316349

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


Sponsor

University of Sao Paulo General Hospital

Enrollment

60 participants

Start Date

Jun 18, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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 32 days, with an initial intervention period of 18 days, followed by a 14-day follow-up period.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing two rehabilitation interventions — resistance exercise and neuromuscular electrical stimulation (NMES, which uses gentle electrical currents to stimulate muscle contractions) — for critically ill patients who have an intra-aortic balloon pump (IABP) inserted in their leg to support their heart. The goal is to prevent muscle weakness in patients who are typically bedbound during this vulnerable period. **You may be eligible if...** - You are 18 years or older - You have an intra-aortic balloon pump in place for more than 48 hours - Your heart and blood pressure are reasonably stable (within defined ranges for heart rate and mean arterial pressure) - You are on low doses of heart support medications (dobutamine ≤20 mcg/kg/min; norepinephrine ≤0.2 mcg/kg/min) - You have had no device failures or bleeding in the last 24 hours **You may NOT be eligible if...** - You have a neurological condition with prior cognitive or motor deficits - You have untreated deep vein thrombosis (blood clot) - You have a prior autoimmune or rheumatic disease - Your hemodynamic (blood pressure/heart rate) status is outside safe ranges Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERIsolated 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.

OTHERNeuromuscular 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.


Locations(1)

Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, Brazil

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NCT06316349


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