ELECTRICAL STIMULATION AND EXERCISE FOR MUSCLE LOSS IN CIRRHOSIS PATIENTS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-12-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Sarcopenia Liver Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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NMES+

Participants will receive resistance exercise combined with NMES treatment.

Group Type EXPERIMENTAL

NMES -

Intervention Type OTHER

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

NMES -

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

Group Type ACTIVE_COMPARATOR

NMES+

Intervention Type OTHER

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

Interventions

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NMES+

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

Intervention Type OTHER

NMES -

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

47 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No