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NOT YET RECRUITING
NCT07017517
NA

NLRP3 Inflammasome and Physical Therapy in ICU-Acquired Weakness

Sponsor: University of Chile

View on ClinicalTrials.gov

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.

Official title: Effect of Physical Therapy on NLRP3 Inflammasome Activation and Muscle Atrophy in Critical Illness Myopathy (PT-NLRP3-CIM).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2025-11

Completion Date

2027-05

Last Updated

2025-09-25

Healthy Volunteers

No

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.

Locations (3)

Clínica INDISA

Santiago, Metropolitan Region, Chile

Hospital de Urgencia Asistencia Pública (HUAP)

Santiago, Metropolitan Region, Chile

University of Chile

Santiago, Metropolitan Region, Chile