TerminatedNot Applicable

Neuromuscular Electrical Stimulation in ICU Patients

Stopped: Due to the pandemic we were unable to recruit patients from the hospital

Brazil56 participantsStarted 2022-03-01

Plain-language summary

The aim of the present study is to evaluate the effects of neuromuscular electrical stimulation (NMES) combined with conventional physiotherapy (Experimental Group), compared to conventional physiotherapy only (Control Group) in critically ill Intensive Care Unit (ICU) patients, by means of a randomized controlled clinical trial. The investigators expect that the NMES program will be able to reduce muscle structure and function losses compared to control group, and will improve muscle quality faster, will reduce the ventilation time and the total time spent at the ICU, as well as improve functionality of these patients. In addition, the researchers expect to understand which mechanisms determine such adaptations in the musculoskeletal system of these patients.

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: * Patients with any clinical condition hospitalized in the ICU, which are monitored by the Physiotherapy Service: * Cerebrovascular diseases * Other bacterial diseases * Circulatory and respiratory diseases * Digestive and abdominal diseases * Liver diseases * Time between the patient's ICU entry and the onset of the NMES intervention less than one week. Patients may be in mechanical ventilation, non-invasive ventilation, oxygen therapy or oxygen ambient ventilation (no ventilatory add). Patients re-admitted to the ICU within the same hospitalization period (i.e., did not leave the hospital) may also be included, as well as patients with previous tracheostomy. Exclusion Criteria: * Previously diagnosed neuromuscular diseases: * ALS * Guillain Barre * Chronic stroke * TRM * End-stage malignant disease * Lower limbs' amputation * Body mass index above 40 kg/m2 * Cachexia (defined as the presence of chronic disease and weight loss ≥ 5% in a period shorter than 12 months or BMI \< 20 kg/m2, associated with at least three of the following criteria: (1) decreased muscle strength; (2) fatigue; (3) anorexia; (4) reduction of fat free mass index; and (5) biochemical abnormalities such as inflammation, anemia or reduction of serum albumin concentration). * Lesions on the skin at the electrode placement and/or dynamometer support points * Post-operative transplantation * Patients using a neuromuscular blocker * Hemodynamic instability (nora \> 10; ABCDE criteria)…

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

Total ICU time

Timeframe: Immediately after each patient discharge from the ICU (7 to 15 days after entry at the ICU, on average).

Mechanical ventilation time

Timeframe: Immediately after each patient mechanical ventilation release (2 to 5 days from intubation start, on average).

Weaning time

Timeframe: Immediately after each patient discharge from the ICU (7 to 15 days after entry at the ICU, on average).

Change in knee extensor evoked force

Timeframe: Change from the patient ICU admission to immediately before ICU discharge (e.g., from day 1 to day 7-15, on average).

Knee extensor maximal voluntary isometric contraction

Timeframe: Immediately before each patient ICU discharge (7 to 15 days after admission, on average).

Knee extensor muscle quality: Real-time ultrasound 9 MHz frequency

Timeframe: Immediately after each patient ICU admission and immediately before ICU discharge (7 to 15 days on average).

Trial details

NCT IDNCT04332263

SponsorFederal University of Rio Grande do Sul

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-01

View on ClinicalTrials.gov More Intensive Care Unit Acquired Weakness trials

Plain-language summary

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.

What they're measuring

Total ICU time

Timeframe: Immediately after each patient discharge from the ICU (7 to 15 days after entry at the ICU, on average).

Mechanical ventilation time

Timeframe: Immediately after each patient mechanical ventilation release (2 to 5 days from intubation start, on average).

Weaning time

Timeframe: Immediately after each patient discharge from the ICU (7 to 15 days after entry at the ICU, on average).

Change in knee extensor evoked force

Timeframe: Change from the patient ICU admission to immediately before ICU discharge (e.g., from day 1 to day 7-15, on average).

Knee extensor maximal voluntary isometric contraction

Timeframe: Immediately before each patient ICU discharge (7 to 15 days after admission, on average).

Knee extensor muscle quality: Real-time ultrasound 9 MHz frequency

Timeframe: Immediately after each patient ICU admission and immediately before ICU discharge (7 to 15 days on average).