ELECTRICAL STIMULATION AND EXERCISE FOR MUSCLE LOSS IN CIRRHOSIS PATIENTS

NCT07162636 | Not Yet Recruiting

• 1 other identifier: 88356025.7.0000.0049
• Study Type: interventional
• Target: 112
• Locations: 0 countries
• Sites: N/A

Brief Summary

Introduction: Sarcopenia, whether primary or secondary, substantially impacts the quality of life of patients post-hospital discharge. Compromised functional capacity can lead to a high prevalence of readmissions. In this context, neuromuscular electrical stimulation (NMES), when combined with voluntary contraction (NMES+), emerges as a promising strategy for optimizing muscle strength gain. Objective: To evaluate the efficacy of NMES+ in improving lower limb muscle strength and physical performance in hospitalized sarcopenic individuals with alcoholic cirrhosis. Methods: This is a double-blind, randomized clinical trial. The Intervention Group will undergo NMES+, while the Control Group will perform resistance exercises. The sample will consist of individuals aged 47 to 70 years, diagnosed with sarcopenia through functional tests: handgrip strength and the 5-repetition sit-to-stand test. The protocol will be applied six times per week. Assessments will be conducted at hospital admission and discharge. Data will be analyzed using Student's T-tests for intergroup and intragroup comparisons; Spearman's or Pearson's correlation will assess the association between hospital readmission rates and physical function at hospital discharge. A p-value of 0.05 was set as statistically significant. Expected Results: To observe a statistically significant increase in muscle strength and physical performance in the Intervention Group, and to find a negative correlation between improved physical function and hospital readmission rates. Conclusion: This study is expected to contribute to more effective rehabilitation protocols, improving functionality and reducing hospital readmission in hospitalized patients with alcoholic liver cirrhosis.

Conditions

Sarcopenia; Liver Cirrhosis

Keywords

SARCOPENIA; LIVER CIRRHOSIS; NMES; HAND GRIP TEST; Five-Repetition Sit-to-Stand Test

Outcome Measures

Primary Outcomes (1)

• Efficacy of resistance exercise combined with NMES

  The primary objective of this clinical trial is to increase muscle strength. This will be measured using the Handgrip Strength (HGS) test, a validated indicator that is particularly useful for hospitalized patients.

  1 mounth

Secondary Outcomes (1)

• Efficacy of resistance exercise combined with NMES

  1 month

Study Arms (2)

NMES+

EXPERIMENTAL

Participants will receive resistance exercise combined with NMES treatment.

Other: NMES -

NMES -

ACTIVE COMPARATOR

To treat and rehabilitate sarcopenia, participants will undergo physical therapy sessions using only resistance exercises

Other: NMES+

Interventions

NMES - OTHER

To treat and rehabilitate sarcopenia, participants will undergo physical therapy sessions using only resistance exercises.

NMES+

Eligibility Criteria

• Age: 47 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized participants with alcoholic cirrhosis.

You may not qualify if:

• Five times sit-to-stand test (5xSTS) below the reference value according to the equation 5xSTS = 3.89 + (0.10 x age).
• Handgrip strength test (HGS) below 27Kgf for men and 16Kgf for women.

Sponsors & Collaborators

• Hospital Universitário Professor Edgard Santos: lead

MeSH Terms

Conditions

Sarcopenia; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes

Central Study Contacts

Priscila Meireles Calil Fontana

CONTACT

+55 71 997032722; priscilamcfontana@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lead Investigator, M.S. in Rehabilitation Sciences.

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: September 9, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF