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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Protein Intake Plus Neuromuscular Electrical Stimulation on Muscle Mass in Hospitalized Elderly: a Randomized Controlled Clinical Study

Conditions
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Atrophy, Muscular

Intervention / Treatment
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* Dietary Supplement: Protein supplementation
* Device: Neuromuscular electrostimulation.
* Dietary Supplement: Placebo (isocaloric supplement)
* Device: Sham for neuromuscular electrostimulation.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Patients allocated to this arm will be submitted to intervention (protein supplementation plus neuromuscular electrostimulation). | Dietary Supplement: Protein supplementation<br>* Patients will receive diary 2 doses of the protein supplement<br>Device: Neuromuscular electrostimulation.<br>* Patients will receive diary sessions of neuromuscular electrostimulation.<br>|
| Placebo Comparator: Placebo<br>Patients allocated to this arm will be submitted to a placebo intervention (isocaloric supplement plus sham for neuromuscular electrostimulation). | Dietary Supplement: Placebo (isocaloric supplement)<br>* Patients will receive diary 2 doses of the isocaloric supplement<br>Device: Sham for neuromuscular electrostimulation.<br>* Patients will not receive neuromuscular electrostimulation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vastus Lateralis Muscle Cross-sectional Area | Vastus Lateralis Muscle Cross-sectional Area will be assessed through ultrasound | From date of admission until the date of medical discharge. Up to 30 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle function | Muscle function evaluated trough battery of test | From date of admission until the date of medical discharge. Up to 30 days. | 
| Nutritional status | Nutritional status will be assessed through nutritional records during hospital stay | From date of admission until the date of medical discharge. Up to 30 days. | 
| Handgrip strength | Strength will be evaluated using handgrip strength test | From date of admission until the date of medical discharge. Up to 30 days. | 
| Functional independence | Functional independence will be assessed using Barthel Index | From date of admission until the date of medical discharge. Up to 30 days. | 
| Length of hospital stay | Length of hospital stay will be the time (in days) until medical discharge. | From date of admission until the date of medical discharge. Up to 30 days. | 
| Mortality | Mortality rate in percent | From date of admission until the date of medical discharge. Up to 30 days. | 
| Hospital readmission post-medical discharge | Hospital readmission post-medical discharge will be the number of times that he is admitted in the hospital post-medical discharge. | 6 months post-medical discharge | 
| Health costs | Health costs will be estimated by means of the questionnaire with questions about the use of health services or equipment. | 6 months post-medical discharge |