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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05008705
• Other study ID #: CAAE43707021.5.0000.0068
• Status: Recruiting
• Phase: N/A
• Start date: August 25, 2021
• Est. completion date: November 1, 2024

Study information

• Verified date: November 2023
• Source: University of Sao Paulo General Hospital
• Contact: Hamilton Roschel, PhD
• Phone: +551130618789
• Email: hars[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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.

Related Conditions & MeSH terms

• Atrophy, Muscular
• Muscular Atrophy

Intervention

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.

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.

Locations

Country	Name	City	State
Brazil	University of Sao Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

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