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Not yet recruitingNCT07162636E-SEEMUpdated Sep 9, 2025

ELECTRICAL STIMULATION AND EXERCISE FOR MUSCLE LOSS IN CIRRHOSIS PATIENTS

An interventional study of NMES+ and NMES - in Sarcopenia and Liver Cirrhosis, sponsored by Hospital Universitário Professor Edgard Santos. Not yet recruiting. Open to participants aged 47 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-09-09.

Sponsored by Hospital Universitário Professor Edgard Santos · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
112
Allocation
Randomized
Ages
47 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Sarcopenia
  • Liver Cirrhosis

Keywords

  • SARCOPENIA
  • LIVER CIRRHOSIS
  • NMES
  • HAND GRIP TEST
  • Five-Repetition Sit-to-Stand Test
03

In context

Sarcopenia

1,329 studies on the registry are indexed under Sarcopenia; 420 are open to participants now.

This study's planned enrollment of 112 is above the median of 60 across 855 interventional studies indexed under Sarcopenia.

Browse Sarcopenia studies →

Lead sponsor

Hospital Universitário Professor Edgard Santos is the lead sponsor of 17 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
47 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Hospitalized participants with alcoholic cirrhosis.

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
112 participants (estimated)

Study arms

  • Experimental
    NMES+

    Participants will receive resistance exercise combined with NMES treatment.

    Other: NMES -

  • Active comparator
    NMES -

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

    Other: NMES+

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.

06

What researchers measure

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.

    Time frame: 1 mounth

Secondary outcomes

  1. Efficacy of resistance exercise combined with NMES

    As 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.

    Time frame: 1 month

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Informed consent form

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07162636
Lead sponsor
Hospital Universitário Professor Edgard Santos
Responsible party
Priscila Meireles Calil Fontana (Lead Investigator, M.S. in Rehabilitation Sciences., Hospital Universitário Professor Edgard Santos) — Principal investigator
First posted
Sep 9, 2025
Start date
Sep 1, 2025 (estimated)
Primary completion
Sep 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Sep 9, 2025

Study contacts

Priscila Meireles Calil Fontana
Contact
priscilamcfontana@hotmail.com
+55 71 997032722

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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