Atrophy, Muscular Clinical Trial
Official title:
Effects of Protein Intake Plus Neuromuscular Electrical Stimulation on Muscle Mass in Hospitalized Elderly: a Randomized Controlled Clinical Study
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | November 1, 2024 |
Est. primary completion date | November 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Brazil | University of Sao Paulo | São Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo General Hospital |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Muscle function | Muscle function evaluated trough battery of test | From date of admission until the date of medical discharge. Up to 30 days. | |
Secondary | 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. | |
Secondary | Handgrip strength | Strength will be evaluated using handgrip strength test | From date of admission until the date of medical discharge. Up to 30 days. | |
Secondary | Functional independence | Functional independence will be assessed using Barthel Index | From date of admission until the date of medical discharge. Up to 30 days. | |
Secondary | 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. | |
Secondary | Mortality | Mortality rate in percent | From date of admission until the date of medical discharge. Up to 30 days. | |
Secondary | 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 | |
Secondary | 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 |
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