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New treatment option for Heart Failure
Official title Isolated Resistance Training and Neuromuscular Electrical Stimulation in Patients With Femoral Intra Aortic Balloon Pump.
ClinicalTrials.gov ID: NCT06316349
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Need for invasive mechanical ventilatory support
- If the patient or responsible family member fails to sign or withdraws the informed consent
See the full eligibility 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 \ 120 mmHg or HR \ 120 bpm
- Occurrence of neurological event with cognitive or motor deficit
- Need for invasive mechanical ventilatory support
- If the patient or responsible family member fails to sign or withdraws the informed consent
The study team makes the final eligibility decision.
Where it's taking place
- São Paulo, São Paulo, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include São Paulo, São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.