Atrophy, Muscular
Conditions
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.
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_SUPPLEMENTProtein supplementation
Patients will receive diary 2 doses of the protein supplement
DEVICENeuromuscular electrostimulation.
Patients will receive diary sessions of neuromuscular electrostimulation.
DIETARY_SUPPLEMENTPlacebo (isocaloric supplement)
Patients will receive diary 2 doses of the isocaloric supplement
DEVICESham for neuromuscular electrostimulation.
Patients will not receive neuromuscular electrostimulation.
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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 |
| Muscle function | From date of admission until the date of medical discharge. Up to 30 days. | Muscle function evaluated trough battery of test |
Countries
Brazil
Contacts
Primary ContactHamilton Roschel, PhD
Outcome results
None listed