Exercise with or without electrical muscle stimulation in heart failure patients
Compares exercise alone with exercise plus electrical stimulation in adults with heart failure.
Plain-language title generated from the registry record
Registry title: Isolated Resistance Training and Neuromuscular Electrical Stimulation in Patients With Femoral Intra Aortic Balloon Pump.
Key facts
- Where
- São Paulo, BrazilSee the site
Where in Brazil
- Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São PauloSão Paulo, BrazilTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Sao Paulo General Hospital
- Trial code
- NCT06316349
- Record updated
- 23 June 2026
- Original description
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:Read full original descriptionShow less
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
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.
Inclusion: 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: Need for invasive mechanical ventilatory support; If the patient or responsible family member fails to sign or withdraws the informed consent.