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| ID | Type | Description | Link |
|---|---|---|---|
| 88356025.7.0000.0049 | Registry Identifier | Research Ethics Committee |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NMES+ | Experimental | Participants will receive resistance exercise combined with NMES treatment. |
|
| NMES - | Active Comparator | To treat and rehabilitate sarcopenia, participants will undergo physical therapy sessions using only resistance exercises |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NMES+ | Other | To treat and rehabilitate sarcopenia, participants will undergo physical therapy sessions, using resistance exercises combined with the use of NMES |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 mounth |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Priscila Meireles Calil Fontana | Contact | +55 71 997032722 | priscilamcfontana@hotmail.com |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| NMES - | Other | To treat and rehabilitate sarcopenia, participants will undergo physical therapy sessions using only resistance exercises. |
|
| 1 month |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |