Protein Intake Plus Neuromuscular Electrical Stimulation on Muscle Mass in Hospitalized Elderly
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Protein supplementation, Neuromuscular electrostimulation., Placebo (isocaloric supplement), Sham for neuromuscular electrostimulation..
- Who it may be relevant to
- Registry conditions: Atrophy, Muscular. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Protein Intake Plus Neuromuscular Electrical Stimulation on Muscle Mass in Hospitalized Elderly: a Randomized Controlled Clinical Study
Overview
This study aims to investigate the effects of supplementation of protein plus sessions of electrostimulation on muscle mass, length of hospital stay, readmission and mortality of hospitalized elderly.
Detailed description
Hospitalized elderly people show malnutrition, physical inactivity, and pronounced systemic inflammation which may be exacerbated the catabolic state and promote drastic muscle wasting during the hospitalization and, thus increasing the length of stay, morbidity, and mortality. Therefore, the aim of this study is to investigate the effects of supplementation of protein plus sessions of electrostimulation on muscle mass, length of hospital stay, readmission, and mortality of hospitalized elderly.
Interventions
- Dietary supplement Protein supplementation
Patients will receive diary 2 doses of the protein supplement - Device Neuromuscular electrostimulation.
Patients will receive diary sessions of neuromuscular electrostimulation. - Dietary supplement Placebo (isocaloric supplement)
Patients will receive diary 2 doses of the isocaloric supplement - Device Sham for neuromuscular electrostimulation.
Patients will not receive neuromuscular electrostimulation.
Primary outcome measures
- Vastus Lateralis Muscle Cross-sectional Area [Time frame: From date of admission until the date of medical discharge. Up to 30 days.]
Secondary outcome measures (8)
- Muscle function [Time frame: From date of admission until the date of medical discharge. Up to 30 days.]
- Nutritional status [Time frame: From date of admission until the date of medical discharge. Up to 30 days.]
- Handgrip strength [Time frame: From date of admission until the date of medical discharge. Up to 30 days.]
- Functional independence [Time frame: From date of admission until the date of medical discharge. Up to 30 days.]
- Length of hospital stay [Time frame: From date of admission until the date of medical discharge. Up to 30 days.]
- Mortality [Time frame: From date of admission until the date of medical discharge. Up to 30 days.]
- Hospital readmission post-medical discharge [Time frame: 6 months post-medical discharge]
- Health costs [Time frame: 6 months post-medical discharge]
Eligibility criteria
Inclusion criteria
- both sex;
- 65 years and older;
- hospital stay less than 48 hours;
Exclusion criteria
- cancer in the last 5 years;
- delirium;
- cognitive deficit that impossibility the patient to read and sign the informed consent form;
- neurological disease;
- neurodegenerative muscular disease;
- impossibility to receive the intervention.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- University of Sao Paulo — São Paulo
Identifiers
NCT: NCT05008705 · CAAE43707021.5.0000.0068