NCT06316349 Isolated Resistance Training and Neuromuscular Electrical Stimulation in Patients With Femoral Intra Aortic Balloon Pump.
| NCT ID | NCT06316349 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Sao Paulo General Hospital |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-06-18 |
| Primary Completion | 2025-03-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-06-18 with a primary completion date of 2025-03-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Rafael M Ianotti, PT
PRINCIPAL INVESTIGATOR
Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Frequently Asked Questions
Who can join the NCT06316349 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06316349 currently recruiting?
Yes, NCT06316349 is actively recruiting participants. Contact the research team at rafael.ianotti@hc.fm.usp.br for enrollment information.
Where is the NCT06316349 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT06316349 clinical trial?
NCT06316349 is sponsored by University of Sao Paulo General Hospital. The principal investigator is Rafael M Ianotti, PT at Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo. The trial plans to enroll 60 participants.
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