Protein Intake Plus Neuromuscular Electrical Stimulation on Muscle Mass in Hospitalized Elderly
- Conditions
- Atrophy, Muscular
- Interventions
- Dietary Supplement: Placebo (isocaloric supplement)Dietary Supplement: Protein supplementationDevice: Sham for neuromuscular electrostimulation.Device: Neuromuscular electrostimulation.
- Registration Number
- NCT05008705
- Lead Sponsor
- University of Sao Paulo General Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- both sex;
- 65 years and older;
- hospital stay less than 48 hours;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo (isocaloric supplement) Patients allocated to this arm will be submitted to a placebo intervention (isocaloric supplement plus sham for neuromuscular electrostimulation). Intervention Protein supplementation Patients allocated to this arm will be submitted to intervention (protein supplementation plus neuromuscular electrostimulation). Placebo Sham for neuromuscular electrostimulation. Patients allocated to this arm will be submitted to a placebo intervention (isocaloric supplement plus sham for neuromuscular electrostimulation). Intervention Neuromuscular electrostimulation. Patients allocated to this arm will be submitted to intervention (protein supplementation plus neuromuscular electrostimulation).
- Primary Outcome Measures
Name Time Method 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
Name Time Method Muscle function From date of admission until the date of medical discharge. Up to 30 days. Muscle function evaluated trough battery of test
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.
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
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.
Functional independence From date of admission until the date of medical discharge. Up to 30 days. Functional independence will be assessed using Barthel Index
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.
Trial Locations
- Locations (1)
University of Sao Paulo
🇧🇷São Paulo, Brazil