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临床试验/NCT07162636
NCT07162636尚未招募不适用

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.

Hospital Universitário Professor Edgard Santos0 个研究点目标入组 112 人开始时间: 2025年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
112
主要终点
Efficacy of resistance exercise combined with NMES

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
47 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Hospitalized participants with alcoholic cirrhosis.

排除标准

  • •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.

研究组 & 干预措施

NMES+

Experimental

Participants will receive resistance exercise combined with NMES treatment.

干预措施: NMES - (Other)

NMES -

Active Comparator

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

干预措施: NMES+ (Other)

结局指标

主要结局

Efficacy of resistance exercise combined with NMES

时间窗: 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.

次要结局

  • Efficacy of resistance exercise combined with NMES(1 month)

研究者

发起方
Hospital Universitário Professor Edgard Santos
申办方类型
Other
责任方
Principal Investigator
主要研究者

Priscila Meireles Calil Fontana

Lead Investigator, M.S. in Rehabilitation Sciences.

Hospital Universitário Professor Edgard Santos

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