Combining exercise with electrical stimulation for heart failure patients using an 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

This study is testing if adding electrical stimulation to an exercise program can help heart failure patients using an intra-aortic balloon pump get stronger and feel better compared to just doing the exercise alone.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Sao Paulo General Hospital (other)
• Locations: 1 site (São Paulo)
• Trial ID: NCT06316349 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the effects of a standardized exercise program alone versus the same program combined with neuromuscular electrical stimulation (NMES) in patients undergoing treatment with an intra-aortic balloon pump due to heart failure. The study will assess muscle architecture and strength through ultrasonographic parameters and evaluate the effectiveness of the interventions over a 32-day period. Participants will be randomly assigned to either the exercise-only group or the exercise plus NMES group, with outcomes measured at the end of the intervention and during follow-up.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have been on an intra-aortic balloon pump for more than 48 hours and meet specific hemodynamic criteria.

Not a fit: Patients requiring invasive mechanical ventilation or those with significant hemodynamic instability may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance muscle strength and function in heart failure patients, potentially improving their recovery and quality of life.

How similar studies have performed: While the combination of exercise and NMES has been explored in other contexts, this specific application in heart failure patients with an intra-aortic balloon pump is relatively novel.

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

Where this trial is running

São Paulo

• Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo — São Paulo, Brazil (RECRUITING)

Study contacts

• Principal investigator: Rafael M Ianotti, PT — Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
• Study coordinator: Rafael M Ianotti, PT

Conditions: Heart Failure, Physical Therapy, Neuromuscular Electrical Stimulation, Intra-Aortic Ballom Pump, Acquired Muscle Weakness, Muscular echo intensity