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

Launched by UNIVERSITY OF SAO PAULO GENERAL HOSPITAL · Mar 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two different exercise programs for patients with heart failure who are receiving treatment with an intra-aortic balloon pump (IABP). One group of participants will follow a standard exercise program, while the other group will do the same exercises but with the addition of neuromuscular electrical stimulation, a technique that uses electrical impulses to help strengthen muscles. The trial aims to see how these approaches affect muscle strength and other important muscle measurements over a total of 32 days, which includes 18 days of active participation followed by a 14-day follow-up.

To be eligible for this trial, participants must be at least 18 years old and have been on the IABP for more than 48 hours, among other health criteria. They should not have serious complications like significant bleeding or unstable blood pressure. Participants can expect to engage in supervised exercise sessions and have their muscle strength and other measurements monitored throughout the study. This research could help determine the best ways to support muscle health in patients undergoing this type of heart treatment.

Gender

ALL

Eligibility criteria

• 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