SarcopeniaE-SEEMNCT07162636
ELECTRICAL STIMULATION AND EXERCISE FOR MUSCLE LOSS IN CIRRHOSIS PATIENTS
A study testing NMES+ and NMES - in people with Sarcopenia and Liver Cirrhosis, run by Hospital Universitário Professor Edgard Santos.
Trial 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. Read more about this study
- Who is it for?
- Ages 47 to 70 years
- Conditions the study is for
- Sarcopenia, Liver Cirrhosis
- What is being tested?
- NMES+ and NMES -
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 47 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized participants with alcoholic cirrhosis.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
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.
Read more
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.
- Conditions
- Sarcopenia, Liver Cirrhosis
- Being tested
- NMES+, NMES -
- Keywords
- SARCOPENIA, LIVER CIRRHOSIS, NMES, HAND GRIP TEST, Five-Repetition Sit-to-Stand Test
- Medical subject headings
- Sarcopenia, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMES+Other
To treat and rehabilitate sarcopenia, participants will undergo physical therapy sessions, using resistance exercises combined with the use of NMES
NMES -Other
To treat and rehabilitate sarcopenia, participants will undergo physical therapy sessions using only resistance exercises.
| Study group | Role | What they receive |
|---|---|---|
| NMES+ | Experimental | Participants will receive resistance exercise combined with NMES treatment. Receives: Other: NMES - |
| NMES - | Active comparator | To treat and rehabilitate sarcopenia, participants will undergo physical therapy sessions using only resistance exercises Receives: Other: NMES+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitário Professor Edgard Santos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Priscila Meireles Calil Fontana, Hospital Universitário Professor Edgard Santos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07162636
- Sponsor's protocol ID
- 88356025.7.0000.0049
- Other IDs
- 88356025.7.0000.0049
- Acronym
- E-SEEM
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07162636
- Acronym / sponsor ID
- E-SEEM / 88356025.7.0000.0049
- Conditions
- Sarcopenia, Liver Cirrhosis
- Keywords
- SARCOPENIA, LIVER CIRRHOSIS, NMES, HAND GRIP TEST, Five-Repetition Sit-to-Stand Test
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Hospital Universitário Professor Edgard SantosUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NMES+ | Experimental | Other: NMES -Participants will receive resistance exercise combined with NMES treatment. |
| NMES - | Active comparator | Other: NMES+To treat and rehabilitate sarcopenia, participants will undergo physical therapy sessions using only resistance exercises |
Who may qualify
- Ages
- 47 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hospitalized participants with alcoholic cirrhosis.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NMES+To treat and rehabilitate sarcopenia, participants will undergo physical therapy sessions, using resistance exercises combined with the use of NMES | Other | NMES - |
| NMES -To treat and rehabilitate sarcopenia, participants will undergo physical therapy sessions using only resistance exercises. | Other | NMES+ |
Primary outcome
Efficacy of resistance exercise combined with NMES
Time frame: 1 mounth
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.
1 secondary outcome
Efficacy of resistance exercise combined with NMES
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing NMES+ and NMES - in people with Sarcopenia and Liver Cirrhosis, run by Hospital Universitário Professor Edgard Santos.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Priscila Meireles Calil Fontana (+55 71 997032722, priscilamcfontana@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of resistance exercise combined with NMES (time frame: 1 mounth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.