Combining exercise with electrical stimulation for heart failure patients using an intra-aortic balloon pump
Official title: 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
Run by University of Sao Paulo General Hospital · NCT06316349 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | University of Sao Paulo General Hospital Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Status | Recruiting |
| Started | June 18, 2024 |
| Main results expected | March 18, 2025 |
| Study ends | May 30, 2027 |
| Registry record updated | June 23, 2026 |
| Trial ID | NCT06316349 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients requiring invasive mechanical ventilation or those with significant hemodynamic instability may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
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
- Email: rafael.ianotti@hc.fm.usp.br
- Phone: +55 11 26615319
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.