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Isolated Resistance Training and Neuromuscular Electrical Stimulation in Patients With Femoral Intra Aortic Balloon Pump.

RecruitingNAAges 18 Years - anyAllUniversity of Sao Paulo General Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 18 years * Intra-aortic balloon pump (IABP) for more than 48 hours * Dobutamine ≤ 20 mcg/kg/min * Norepinephrine ≤ 0.2 mcg/kg/min (35) * Absence of device failures or bleeding in the last 24 hours * Mean arterial pressure (MAP) ≥ 60 mmHg and ≤ 120 mmHg * Heart rate (HR) ≥ 60 bpm and ≤ 120 bpm * Absence of neurological event with previous cognitive or motor deficit * Presence of untreated deep venous thrombosis * Absence of previous autoimmune diseases * Absence of previous rheumatic diseases Protocol Discontinuation Criteria: * Need for norepinephrine \> 0.2 mcg/kg/min * Acute arrhythmia of any etiology with hemodynamic instability * Hemodynamic instability: MAP \< 60 mmHg or \>120 mmHg or HR \< 60 bpm or \> 120 bpm * Occurrence of neurological event with cognitive or motor deficit Exclusion Criteria: * Need for invasive mechanical ventilatory support * If the patient or responsible family member fails to sign or withdraws the informed consent
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What it tests

  • Isolated Resistance Training Program
  • Neuromuscular electrical stimulation
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Where

1 site
Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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