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Could a jolt of electricity help heart patients rebuild leg muscle faster?

NCT ID NCT06316349

Disease control Sponsor: University of Sao Paulo General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares a standard leg exercise program alone versus the same program combined with neuromuscular electrical stimulation (NMES) in heart failure patients who have a temporary heart pump (intra-aortic balloon pump) in their leg. The goal is to see if adding NMES helps preserve or restore thigh muscle size, strength, and quality. Participants will follow an 18-day exercise protocol, with muscle measurements taken via ultrasound and strength tests, followed by a 14-day observation period.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
neuromuscular electrical stimulation
What this could lead to
If effective, this approach could speed up muscle recovery and improve mobility for heart failure patients who need temporary mechanical heart support.
What could go wrong
This is a small, early-stage trial with only 60 participants, so results may not apply to all patients. The intervention is short-term, and long-term benefits are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure Neuromuscular electrical stimulation Physical therapy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

    RECRUITING

    São Paulo, São Paulo, 05403-000, Brazil

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