Isolated Resistance Training and Neuromuscular Electrical Stimulation in Patients With Femoral In… (NCT06316349) | Clinical Trial Compass
RecruitingNot Applicable
Isolated Resistance Training and Neuromuscular Electrical Stimulation in Patients With Femoral Intra Aortic Balloon Pump.
Brazil60 participantsStarted 2024-06-18
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To investigate echo intensity of the rectus femoris muscle.
Timeframe: The data will be collected on the day of protocol initiation (baseline), on the first day after the 10th and 15th days of intervention and on the 14th day after the last day of intervention.