Intensive Care Unit Acquired Weakness

11

Review clinical trials related to Intensive Care Unit Acquired Weakness. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Application of the Concept of Proprioceptive Neuromuscular Facilitation in Trunk Control in Patients Admitted to the ICU.

Muscle weakness acquired in the ICU (FAUTI) is related to the functional decline of patients admitted to an Intensive Care Unit (ICU). For better follow-up, scales such as (Chelsea Critical Care Physical Assessment) CPAx and (Medical Research Council) MRC help to identify early the muscle and functional impairment of these patients. Early mobilization aims to minimize these effects and therefore the search to reach the highest mobility milestone is constant bedside sitting (BSS) is an important milestone in recovery, associated with better functional results when there is good trunk control, as the coordinated activation of muscles in this region is essential for stabilization and reaching higher postures. The physiotherapeutic approach focused on the components of the activities and on the patient's participation is crucial, with the therapeutic option of Proprioceptive Neuromuscular Facilitation (PNF). To evaluate the effect of exercises based on the PNF concept through the Test Control Trunk (TCT) on the trunk balance of patients admitted to the ICU. This is a randomized, crossover clinical trial, carried out at the Pedro Ernesto University Hospital from June 2026 to June 2027. Adults hospitalized for more than 48 hours who meet the inclusion criteria will be screened. and clinical evaluation. The study consists of two blocks of pre- and post-crossover evaluations, conducted by the same blind evaluator. Patients will undergo assessments on the first day of BSS, including assessment of the trunk with TCT and assessment of diaphragm mobility and thickness by ultrasound, before and after intervention (PNF or conventional exercises). Between assessments, there will be a 3-hour rest period.

Participants needed: 58
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Universidade Federal do Rio de JaneiroUpdated: May 22, 2026Locations: 1
Eligibility criteria

Over 18 years of age [+3]

Patients in a coma, with spinal cord instability, metastases, and bone lesions; [+4]

Status: Recruiting

Locomotor Muscle Oxygenation and Activation During Acute Interval Compared to Constant-load Bed-cycling Exercise

Up to 60% of patients admitted to the Intensive Care Unit (ICU) with a prolonged stay in the ICU develop complications such as intensive care unit acquired weakness (ICUAW) characterized by limb and respiratory muscle weakness. ICUAW is associated with worse prognosis, longer ICU stay and increased morbidity and mortality. Physical therapy (PT) interventions in the intensive care unit (ICU), can improve patients' outcomes. However, improvements in muscle function achieved with standard physical activity interventions aiming at early mobilization are highly variable due to lack of consistency in definition of the interventions, lack of consideration for the complexity of exercise dose and/or insufficient stimulation of muscles during interventions. It has been suggested that modifying early mobilization and exercise protocols towards shorter intervals consisting of higher intensity exercises might result in more optimal stimulation of muscles. In the present study the researchers therefore aim to simultaneously assess (by non-invasive technologies) locomotor muscle oxygenation and activation along with the measurements of the load imposed on respiration and circulation during two different training modalities i.e., moderate intensity continuous bed-cycling (endurance training) vs high-intensity alternated by lower intensity periods of bed-cycling (interval training).

Participants needed: 100
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: KU LeuvenUpdated: Mar 18, 2026Locations: 1
Eligibility criteria

Full cooperatively adult patients indicated by the Adequacy Score of standardize... [+3]

Pre-existing functional limitations [+26]

Status: Recruiting

Clinical Effectiveness of the "PICU Up!" Multifaceted Early Mobility Intervention for Critically Ill Children

While mortality in U.S. pediatric intensive care units (PICUs) is improving, surviving children frequently develop persistent physical, cognitive, and psychological impairments. Over half of critically ill children experience potentially preventable PICU-acquired morbidities, with mechanically ventilated children being at greatest risk. In critically ill adults, randomized trials have shown that progressive mobility, started early (within 3 days of initiating mechanical ventilation), decreases muscle weakness and the duration of mechanical ventilation. However, similar randomized studies have not been conducted in the PICU. The investigator's prior studies revealed that less than 10 percent of critically ill children at the highest risk of functional decline are evaluated by a physical or occupational therapist within 3 days of PICU admission. Given the interplay of sedation, delirium, sleep, and immobility in the PICU, single-component interventions, such as sedation protocolization, have not consistently shown benefit for decreasing mechanical ventilation duration. Thus, the investigators developed the first pediatric-specific, interprofessional intervention (PICU Up!) to integrate goal-directed sedation, delirium prevention, sleep promotion, and family engagement into daily PICU care in order to facilitate early and progressive mobility. The investigators have demonstrated the safety and feasibility of this pragmatic, multifaceted strategy in both single-site and multicenter pilot studies. Hence, the next phase of the investigators research is to evaluate the clinical effectiveness and delivery of the PICU Up! intervention across a range of PICU patients and health systems. The investigators propose a pragmatic, stepped-wedge, cluster randomized controlled trial that will include 10 academic and community hospitals in the United States, with the following Aims: 1) Evaluate if the PICU Up! intervention, delivered under real-world conditions, decreases mechanical ventilation duration (primary outcome) and improves delirium and functional status compared to usual care in critically ill children; and 2) Conduct a multi-stakeholder, mixed-methods process evaluation to identify key contextual factors associated with delivery of PICU Up!. If proven effective, the PICU Up! intervention has potential to profoundly change medical care in the PICU and substantially impact public health by improving outcomes for the growing number of pediatric survivors of critical illness.

Participants needed: 1,440
Trial details
Age: Up to 18Biological sex: AllType: InterventionalSponsor: Johns Hopkins UniversityUpdated: Mar 18, 2026Locations: 11
Eligibility criteria

Invasive mechanical ventilation via oral or nasal endotracheal tube ≥ 48 hours a...

Active or anticipated withdrawal of life support within 48 hours [+2]

Status: Recruiting

Technology-Assisted Early Mobilization Program Among Patients in the Intensive Care Units

This single-blind, three-group parallel randomized controlled trial will involve 138 patients with critical illness, randomly assigned at a 1:1:1 ratio to the technology-assisted early mobilization group (46 patients), the systematic early mobilization group (46 patients), or the control group (46 patients). The technology-assisted early mobilization group will receive interventions within 72 hours of ventilator use. The interventions include protocol-oriented early mobilization program carried out by physiotherapist and researcher and technology-assisted in-bed activities primarily assisted by family members. The systematic early mobilization group will receive only the similar protocol-oriented early mobilization program within 72 hours of ventilator use. The control group will receive routine rehabilitation as usual. The primary outcomes include occurrence of intensive care unit-acquired weakness (ICUAW). Secondary outcomes include muscle strength, delirium, sleep status, clinical outcomes, activities of daily living, and quality of life. Measurements will be assessed on the day of enrollment, during the ICU stay, on the day of ICU discharge (or up to 28 days), on the day of hospital discharge, and six months after hospital discharge.

Participants needed: 138
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Hsiao-Yean ChiuUpdated: Mar 9, 2026Locations: 1
Eligibility criteria

Aged ≥ 18 years [+5]

Have developed delirium before enrollment (ICDSC > 4) [+2]

Status: Recruiting

Functional Assessment in Critically Ill Patients

This longitudinal, prospective observational study aims to evaluate functional status in critically ill adult patients in the Intensive Care Unit using the Chelsea Critical Care Physical Assessment Tool (CPAx). The primary objective is to analyze CPAx score variation as a potential predictor of clinical outcomes, including mortality and duration of mechanical ventilation. Functional assessments will be performed at intensive care unit (ICU) admission and discharge to monitor changes in physical function and to predict adverse clinical outcomes.

Participants needed: 186
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Universidade Federal do Rio de JaneiroUpdated: Sep 25, 2025Locations: 1Duration: 10 Days
Eligibility criteria

Pregnancy [+3]

Status: Not yet recruiting

Virtual Reality in Intensive Care Unit: Patient Satisfaction, Clinical and Functional Outcomes, Feasibility

Background: Virtual reality is recognized as a progressive technology with the potential to enhance the rehabilitation process. Immersive virtual reality-based treatments can improve motor outcomes in physical rehabilitation, reduce stress caused by the intensive care unit environment and maximize patients' recovery processes. Objective: To analyze the efficacy of rehabilitation using immersive virtual reality on patient satisfaction and experience, functional and clinical outcomes and the feasibility of its application during the hospitalization period in an intensive care unit (ICU). Methods: This is a randomized controlled clinical trial involving ICU patients aged 18 years or older, with an estimated ICU stay of ≥ 72 hours, the ability to understand and follow verbal instructions and no diagnosis of psychotic disorders, visual impairment, or hearing loss. Patients will be divided into two groups: one undergoing traditional physiotherapy rehabilitation - control group (CG), and the other receiving physiotherapy using immersive virtual reality (IVR group). The following evaluations will be conducted: mobility condition, physical and psychological discomfort, estimated physical activity level, occurrence of delirium, cognitive decline screening, functionality classification, motivation level, patient experience, sense of immersion in the virtual reality environment, patient satisfaction during the rehabilitation process, occurrence of adverse events, and protocol feasibility. Data will be presented in graphs and tables. Results will be considered statistically significant at a 5% significance level (p ≤ 0.05), and all analyses will be performed using SPSS Statistics version 22. Expected results: The investigators expect to find evidence that rehabilitation using immersive virtual reality can promote and enable a more pleasant and less traumatic experience during the patient's hospitalization, with greater satisfaction and adherence to the proposed rehabilitation, in addition to being an effective tool to optimize patients' functional and clinical outcomes.

Participants needed: 90
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Hospital Sirio-LibanesUpdated: Sep 12, 2025Locations: 1
Eligibility criteria

Aged ≥18 years [+7]

Hemodynamic instability [+3]

Status: Not yet recruiting

Early Assessment of Quadriceps Muscle Recovery by Dynamometry and 3D Ultrasound in Intensive Care Patients Under Invasive Mechanical Ventilation

Patients in intensive care often develop acquired muscle weakness (ICUAW or Intensive Care Unit Acquired Weakness) due to immobilization and muscle atrophy. Early mobilization can help reduce weakness and improve functional recovery, but practices vary. Muscle strength assessment, particularly using the MRC (Medical Research Council) score, is crucial, though it has precision limitations. Additional methods, such as manual dynamometry and functional scales, are needed to better track muscle recovery. The quadriceps, important for function, requires early evaluation, but there is a lack of specific data in intensive care to predict medium-term functional recovery.

Participants needed: 100
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Nantes University HospitalUpdated: Jul 17, 2025Locations: 1
Eligibility criteria

Adults aged > 18 years [+5]

Pregnant or breastfeeding women [+10]

Status: Recruiting

AI Based Muscular Ultrasound to Assess Intensive Care Unit-acquired Weakness

The aim of this observational case-control study is to investigate, whether artificial intelligence can detect ultrasound-derived imaging characteristics typical for intensive care unit-acquired weakness. The main questions it aims to answer are: 1. Is the evaluation of specific parameters of neuromuscular ultrasound using AI-based image analysis suitable for detecting and monitoring critically ill ICU patients with ICUAW? 2. Do the results of AI-based ultrasound image analysis correlate with: (A) the severity of ICUAW (B) the visual grading of muscle echogenicity (C) the 30- and 90-day-outcome?

Participants needed: 50
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Jena University HospitalUpdated: Jan 9, 2025Locations: 1
Eligibility criteria

Patients aged 18 years or above [+3]

No informed consent [+5]

Status: Recruiting

Skeletal Muscle Regeneration in Survivors of Critical Illness: How to Prevent Satellite Cell Failure?

Modern intensive care enables patients to survive insults that in the past would have been supralethal. Nonetheless, increased number of survivors suffer from failed functional outcomes associated with prolonged muscle weakness and fatiguability. Whilst alterations of skeletal muscle biology that occur during critical illness slowly disappear over the period of months, muscle weakness remains. Recent pilot studies have shown that muscle weakness is associated with loss and alteration of satellite skeletal muscle cells, which are supposed to proliferate and repair damaged muscle tissue. The pathogenesis of this phenomenon has not been fully understood. In this grant project, we will study function and structure of satellite cells and their organelles (particularly mitochondria) using both classical bioenergetics and advanced microscopic techniques. Satellite cells will be isolated from biopsies taken from critically ill patients with developed muscle weakness in the acute and protracted phase of a disease and after 6 months. In time points, an ultrasound examination of muscle mass will be performed, and metabolism will be assessed using insulin clamps. In an in vitro experiments, we will test also effect of nutritional and anabolic factors and drugs, commonly used in ICU, on satellite cells. In a control branch, cells will be isolated from skeletal muscle of volunteers undergoing elective hip replacement surgery. Results of this study could significantly contribute to understanding of mechanisms leading to ICU acquired muscle weakness and to identify therapeutic strategy in future.

Participants needed: 50
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Charles University, Czech RepublicUpdated: Jan 1, 2025Locations: 1
Eligibility criteria

Critically ill patients receiving mechanical ventilation, to be enrolled within... [+2]

Unlikely to survive 6 months [+5]

Status: Recruiting

Hemodynamic Phenotype-Based,Capillary Refill Time-Targeted Resuscitation In Early Septic Shock:ANDROMEDA-SHOCK-2

Over-resuscitation including fluid overload has been associated with increased morbidity (prolonged duration of organ failure) and mortality in septic shock. "One-size-fits-all" resuscitation strategies may increase septic shock mortality. However, clinical studies on individualized resuscitation are lacking. Hemodynamic phenotyping may allow to individualize septic shock resuscitation. The ANDROMEDA-SHOCK trial found that a simple clinical and bedside CRT-targeted resuscitation reduces organ dysfunction and 28-day mortality in septic shock. The current study will examine the hypothesis that a CRT-targeted resuscitation based on hemodynamic phenotyping considering within an decision tree usual bedside clinical parameters such as pulse pressure, diastolic blood pressure, fluid responsiveness and cardiac performance can further decrease mortality in septic shock as compared to usual care.

Participants needed: 180
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Assistance Publique - Hôpitaux de ParisUpdated: Dec 5, 2024Locations: 1
Eligibility criteria

Consecutive adult patients (≥ 18 years) [+2]

More than 4 hours since septic shock diagnosis, [+14]

Status: Recruiting

Feasibility and Safety of Early Mobilization and Rehabilitation in Intensive Care Unit Patients

Intensive Care Unit Acquired Weakness (ICU-AW) is a common complication of critical illnesses, occurring in approximately 50% of ICU patients and is strongly associated with increased morbidity, physical impairments, and both short- and long-term mortality. The main characteristics of ICU-AW are symmetrical generalised muscle weakness affecting both respiratory and limb muscles; however, the clinical phenotype may differ depending on age, disease burden, length of ICU stay, and mechanical ventilation duration. The objective of the present study is to evaluate the feasibility achieved and the safety outcomes reported in a cohort of critically ill patients who undergo early mobilisation and rehabilitation in intensive care units. This research is a multicentre prospective cohort study.

Participants needed: 220
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Claudia AristizábalUpdated: Oct 23, 2024Locations: 4
Eligibility criteria

Patients ≥ 18 years of age admitted to the intensive care units.

Patients requiring extracorporeal membrane oxygenation (ECMO). [+2]