ELECTRICAL STIMULATION AND EXERCISE FOR MUSCLE LOSS IN CIRRHOSIS PATIENTS (E-SEEM)

Hospital Universitário Professor Edgard Santos

Status: Not yet enrolling

Conditions: Liver Cirrhosis; Sarcopenia

Treatments: Other: NMES+; Other: NMES -

Study type: Interventional

Funder types: Other

Identifiers

NCT07162636

88356025.7.0000.0049 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 112 estimated patients

Sex: All

Ages: 47 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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112 participants in 2 patient groups

NMES+

Experimental group

Description:

Participants will receive resistance exercise combined with NMES treatment.

Treatment:

Other: NMES -

NMES -

Active Comparator group

Description:

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

Treatment:

Other: NMES+