Protein Intake Plus Neuromuscular Electrical Stimulation on Muscle Mass in Hospitalized Elderly

University of Sao Paulo General Hospital

Status: Enrolling

Conditions: Atrophy, Muscular

Treatments: Dietary Supplement: Placebo (isocaloric supplement); Device: Neuromuscular electrostimulation.; Device: Sham for neuromuscular electrostimulation.; Dietary Supplement: Protein supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT05008705

CAAE43707021.5.0000.0068

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

Patients allocated to this arm will be submitted to intervention (protein supplementation plus neuromuscular electrostimulation).

Treatment:

Dietary Supplement: Protein supplementation

Device: Neuromuscular electrostimulation.

Placebo

Placebo Comparator group

Description:

Patients allocated to this arm will be submitted to a placebo intervention (isocaloric supplement plus sham for neuromuscular electrostimulation).

Treatment:

Device: Sham for neuromuscular electrostimulation.

Dietary Supplement: Placebo (isocaloric supplement)