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NLRP3 Inflammasome and Physical Therapy in ICU-Acquired Weakness

NCT07017517 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-05-06

No results posted yet for this study

Summary

The goal of this clinical trial is to study whether physical therapy can reduce NLRP3 inflammasome activation and muscle atrophy in patients with critical illness myopathy (CIM). It will also explore the role of NLRP3 inflammasome in the pathophysiology of CIM.

The main questions this study aims to answer are:

Is NLRP3 inflammasome activation associated with muscle atrophy through the upregulation of atrogenes?

Does physical therapy attenuate NLRP3 inflammasome activation in skeletal muscle, thereby contributing to the prevention or reduction of muscle atrophy in CIM?

Researchers will compare enhanced physical therapy using servo-assisted bed cycling (Motomed Letto®) in critically ill patients at risk of developing CIM during the early phase of ICU stay to conventional physical therapy (standard physiotherapy), to assess whether physical therapy reduces NLRP3 inflammasome activation and muscle degradation.

Participants will:

Be randomized to receive either conventional physical therapy or enhanced physical therapy (Motomed Letto®) for 7 consecutive days. A control group of patients without CIM will also be included.

Undergo assessments of NLRP3 activity, muscle atrophy markers, and transcriptomic profiles from serum and vastus lateralis muscle biopsies.

Be clinically evaluated using the SOFA scale and muscle ultrasound for CIM diagnosis.

Be followed up for changes in muscle strength and physical functionality.

Provide sociodemographic and clinical information to be recorded throughout the study.

Conditions

  • Critical Illness Myopathy

Interventions

DEVICE

Motomed Letto® servo-assisted cycling + standard physiotherapy

Servo-assisted cycling using the Motomed Letto® device with a cadence target of 30 revolutions per minute (rpm), performed for 60 minutes twice daily for 7 days. This intervention is administered in addition to standard ICU physiotherapy to critically ill patients at risk of critical illness myopathy (CIM).

BEHAVIORAL

Standard physiotherapy

Standard physiotherapy including mobilization and passive/active range-of-motion exercises, delivered during routine ICU care for 7 days.

Sponsors & Collaborators

  • Clinica Indisa

    collaborator OTHER

  • Hospital de Urgencia y Asistencia Pública

    collaborator UNKNOWN

  • University of Chile

    lead OTHER

Principal Investigators

  • Paola A Llanos, PhD · University of Chile

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-20
Primary Completion
2027-05-31
Completion
2027-05-31

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07017517 on ClinicalTrials.gov