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Not yet recruiting NCT07162636

ELECTRICAL STIMULATION AND EXERCISE FOR MUSCLE LOSS IN CIRRHOSIS PATIENTS

No phase Interventional Sarcopenia Liver Cirrhosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NMES+, NMES -.
Who it may be relevant to
Registry conditions: Sarcopenia, Liver Cirrhosis. Basic parameters: 47 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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.

Overview

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

  • Other NMES+
    To treat and rehabilitate sarcopenia, participants will undergo physical therapy sessions, using resistance exercises combined with the use of NMES
  • Other NMES -
    To treat and rehabilitate sarcopenia, participants will undergo physical therapy sessions using only resistance exercises.

Primary outcome measures

  • Efficacy of resistance exercise combined with NMES [Time frame: 1 mounth]
Secondary outcome measures (1)
  • Efficacy of resistance exercise combined with NMES [Time frame: 1 month]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07162636 · 88356025.7.0000.0049 · 88356025.7.0000.0049

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗