Protein Intake Plus Neuromuscular Electrical Stimulation on Muscle Mass in Hospitalized Elderly
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention Patients allocated to this arm will be submitted to intervention (protein supplementation plus neuromuscular electrostimulation). |
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.
|
| Placebo Comparator: Placebo Patients allocated to this arm will be submitted to a placebo intervention (isocaloric supplement plus sham for 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.
|
Outcome Measures
Primary Outcome Measures
- Vastus Lateralis Muscle Cross-sectional Area [From date of admission until the date of medical discharge. Up to 30 days.]
Vastus Lateralis Muscle Cross-sectional Area will be assessed through ultrasound
Secondary Outcome Measures
- Muscle function [From date of admission until the date of medical discharge. Up to 30 days.]
Muscle function evaluated trough battery of test
- Nutritional status [From date of admission until the date of medical discharge. Up to 30 days.]
Nutritional status will be assessed through nutritional records during hospital stay
- Handgrip strength [From date of admission until the date of medical discharge. Up to 30 days.]
Strength will be evaluated using handgrip strength test
- Functional independence [From date of admission until the date of medical discharge. Up to 30 days.]
Functional independence will be assessed using Barthel Index
- Length of hospital stay [From date of admission until the date of medical discharge. Up to 30 days.]
Length of hospital stay will be the time (in days) until medical discharge.
- Mortality [From date of admission until the date of medical discharge. Up to 30 days.]
Mortality rate in percent
- Hospital readmission post-medical discharge [6 months post-medical discharge]
Hospital readmission post-medical discharge will be the number of times that he is admitted in the hospital post-medical discharge.
- Health costs [6 months post-medical discharge]
Health costs will be estimated by means of the questionnaire with questions about the use of health services or equipment.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Sao Paulo | São Paulo | Brazil | 05508-030 |
Sponsors and Collaborators
- University of Sao Paulo General Hospital
Investigators
- Principal Investigator: Hamilton Roschel, PhD, University of Sao Paulo General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CAAE43707021.5.0000.0068