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ELECTRICAL STIMULATION AND EXERCISE FOR MUSCLE LOSS IN CIRRHOSIS PATIENTS

FUNCTIONAL CAPACITY ANALYSIS THROUGH NEUROMUSCULAR ELECTRICAL STIMULATION COMBINED WITH RESISTANCE EXERCISE IN HOSPITALIZED SARCOPENIC INDIVIDUALS WITH ALCOHOLIC LIVER CIRRHOSIS: A DOUBLE-BLINDED RANDOMIZED CLINICAL TRIAL.

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07162636
Acronym
E-SEEM
Enrollment
112
Registered
2025-09-09
Start date
2025-09-01
Completion date
2026-12-30
Last updated
2025-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhosis, Sarcopenia

Keywords

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

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.

Interventions

OTHERNMES+

To treat and rehabilitate sarcopenia, participants will undergo physical therapy sessions, using resistance exercises combined with the use of NMES

OTHERNMES -

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

Sponsors

Hospital Universitário Professor Edgard Santos
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
47 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Hospitalized participants with alcoholic cirrhosis.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Efficacy of resistance exercise combined with NMES1 mounthThe 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.

Secondary

MeasureTime frameDescription
Efficacy of resistance exercise combined with NMES1 monthAs a secondary objective, physical performance and functional lower limb strength will be evaluated, as they are directly impacted by sarcopenia. This assessment will be conducted using the five-repetition sit-to-stand test. Participants will be evaluated upon hospital admission and at discharge. A one-month post-discharge follow-up, conducted via telephone, will aim to monitor for potential hospital readmissions. This approach will allow for an investigation into the association between the readmission rate and physical function scores measured at the time of discharge. This study focuses on clinically relevant outcomes that directly impact patients' quality of life.

Contacts

Primary ContactPriscila Meireles Calil Fontana
priscilamcfontana@hotmail.com+55 71 997032722

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026