NCT06316349Recruiting
Isolated Resistance Training and Neuromuscular Electrical Stimulation in Patients With Femoral 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
Source: ClinicalTrials.gov · Last updated 23 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 19 Feb 2024
- Start date
- 18 Jun 2024
- Primary completion date
- 18 Mar 2025
- Lead sponsor
- University of Sao Paulo General Hospital
- Diseases
- Heart failure
- NCT number
- NCT06316349
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 18 Jun 2024 to the primary completion date, 18 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Need for invasive mechanical ventilatory support
- If the patient or responsible family member fails to sign or withdraws the informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.