Physical therapy and NLRP3-related ICU-acquired muscle weakness

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized interventional study will assign critically ill, septic patients expected to require prolonged mechanical ventilation to either enhanced physical therapy with Motomed Letto® servo-assisted bed cycling plus standard physiotherapy or to standard physiotherapy alone during the early ICU stay. Researchers will measure markers of NLRP3 inflammasome activation and atrogene expression alongside clinical indicators of muscle degradation and function. The trial focuses on patients with high organ failure scores who are at elevated risk for ICU-acquired weakness, and compares molecular and clinical outcomes between the two physical therapy approaches. The aim is to determine whether early, intensified mobilization reduces inflammatory signaling in skeletal muscle and limits atrophy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Medical diagnosis of sepsis upon ICU admission.
* Receiving invasive mechanical ventilation with a projected requirement ≥7 days.
* SOFA score ≥8 for three consecutive days within the first five days of ICU admission.

Exclusion Criteria:

* Neurocritical illness.
* Prior malnutrition or cachexia.
* Pre-existing neuromuscular disease.
* Coagulopathy (severe liver disease or continuous dialysis).
* Thrombocytopenia \<20,000 platelets/μL.
* Prior Clinical Frailty Scale ≥4.
* Lower limb amputation or fractures.
* Ongoing chemotherapy.
* Pregnancy.
* BMI \>35.
* Uncontrolled epilepsy.
* Allergy to ultrasound gel.
* Prior prolonged corticosteroid therapy.
* Expected ICU stay \<7 days.
* Imminent death.
* Legal guardian refusal to provide informed consent.

Where it's running

• Clínica INDISA
  Santiago, Metropolitan Region, Chile Recruiting
• Hospital de Urgencia Asistencia Pública (HUAP)
  Santiago, Metropolitan Region, Chile Recruiting
• University of Chile
  Santiago, Metropolitan Region, Chile Recruiting

Study contacts

• Study coordinator: Óscar L Arellano-Pérez, MSc.
• Email: oscar.arellano@ug.uchile.cl
• Phone: +56961479414

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Critical-illness–related muscle and nerve weakness in adults hospitalized outside the ICU

  This project will test how often adults hospitalized with acute illness outside the ICU develop severe muscle and nerve weakness by comparing patients with organ failure to those without.

  Recruiting Istituto Clinico Humanitas · Rozzano · NCT07478367

• High-tech rehabilitation program for adults with acute neuromuscular disease

  This trial will test whether a high-tech rehab program using robotics, virtual reality, and balance platforms helps adults with acute neuromuscular conditions improve balance, strength, fatigue, and quality of life more than usual therapy.

  Recruiting Istituti Clinici Scientifici Maugeri SpA · Bari and 7 other locations · NCT06822231

• Improving walking recovery in patients with muscle weakness from critical illness

  This study is testing if using electrical stimulation during rehabilitation can help critically ill patients with muscle weakness walk better and recover faster.

  Recruiting Fondazione Don Carlo Gnocchi ETS · Milan · NCT06786390

• Study on muscle weakness after surgery in intensive care patients

  This study is testing if changes in blood and muscle samples from surgical patients can help us understand and find markers for muscle weakness that happens after being in intensive care.

  Recruiting Technical University of Munich · Vienna, State of Vienna and 2 other locations · NCT03810768

• Observing recovery from weakness after severe respiratory and cardiac failure

  This study looks at how people who had severe breathing and heart problems recover from weakness after being in intensive care and on a special life-support machine, to see what helps or hinders their recovery.

  Recruiting Barts & The London NHS Trust · London · NCT03753412

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.