Isolated Resistance Training and Neuromuscular Electrical Stimulation in Patients With Femoral Intra Aortic Balloon Pump.
Recruiting · NCT06316349 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Sao Paulo General Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
1 location listed.
- Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - São Paulo, São Paulo, Brazil