|

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

RECRUITINGN/ASponsored by University of Sao Paulo General Hospital
Actively Recruiting
PhaseN/A
SponsorUniversity of Sao Paulo General Hospital
Started2024-06-18
Est. completion2025-03-18
Eligibility
Age18 Years+
Healthy vol.Accepted

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions4

Heart DiseaseHeart FailureNeuromuscular Electrical StimulationPhysical Therapy

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.