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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 112
- Primary Endpoint
- Efficacy of resistance exercise combined with NMES
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 47 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
NMES+
Participants will receive resistance exercise combined with NMES treatment.
Intervention: NMES - (Other)
NMES -
To treat and rehabilitate sarcopenia, participants will undergo physical therapy sessions using only resistance exercises
Intervention: NMES+ (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Efficacy of resistance exercise combined with NMES(1 month)
Investigators
Priscila Meireles Calil Fontana
Lead Investigator, M.S. in Rehabilitation Sciences.
Hospital Universitário Professor Edgard Santos