Skeletal Muscle Mass on Prognosis and Recovery in Clinical Trial

NCT ID: NCT07034170

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2028-12-31

Brief Summary

The objective of this research project is to develop an automated muscle mass measurement system based on computed tomography (CT) images using deep learning and artificial intelligence, and to construct a prognostic prediction model for patients who have experienced cardiac arrest and undergone resuscitation. The model will be validated using multicenter registry data and medical imaging. Furthermore, a clinical trial involving core muscle rehabilitation for post-resuscitation patients will be conducted to evaluate both short-term and long-term outcomes, aiming to comprehensively understand the impact of muscle mass on the prognosis of patients after cardiac arrest.

Conditions

Out of Hospital Cardiac Arrest; Inhospital Cardiac Arrest

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention Group

Group Type: EXPERIMENTAL

Enhanced Rehabilitation Program

Intervention Type: BEHAVIORAL

Participants in the intervention group receive an enhanced rehabilitation program, including muscular electrical stimulation, guided active rehabilitation sessions, and structured physical engagement during periods of consciousness. The intervention is designed to promote functional improvement in post-cardiac arrest patients.

Interventions

Enhanced Rehabilitation Program

Participants in the intervention group receive an enhanced rehabilitation program, including muscular electrical stimulation, guided active rehabilitation sessions, and structured physical engagement during periods of consciousness. The intervention is designed to promote functional improvement in post-cardiac arrest patients.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Non-traumatic adult patients who experienced sudden cardiac arrest
• Achieved sustained return of spontaneous circulation (ROSC) for more than five minutes following successful resuscitation
• Admitted to the ICU
• Survived beyond 72 hours without successful weaning from mechanical ventilation

Exclusion Criteria

• Age under 18 years
• Pregnancy
• Expected to be weaned from mechanical ventilation within 48 hours
• Terminal-stage cancer or unwillingness to receive aggressive treatment
• Unavailability of ICU care due to overcrowding in the emergency intensive care unit
• Refusal to participate in the study by the patient or family members
• Presence of an implanted pacemaker or defibrillator
• Open wounds, severe edema, or deep vein thrombosis in the lower limbs
• Pre-arrest status limited to wheelchair use or bedridden, unable to ambulate

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Emergency Medicine, National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

202501085RIND

Identifier Type: -

Identifier Source: org_study_id