Protein Intake Plus Neuromuscular Electrical Stimulation on Muscle Mass in Hospitalized Elderly
Primary Purpose
Atrophy, Muscular
Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Protein supplementation
Neuromuscular electrostimulation.
Placebo (isocaloric supplement)
Sham for neuromuscular electrostimulation.
Sponsored by
About this trial
This is an interventional treatment trial for Atrophy, Muscular
Eligibility 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.
Sites / Locations
- University of Sao PauloRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention
Placebo
Arm Description
Patients allocated to this arm will be submitted to intervention (protein supplementation plus neuromuscular electrostimulation).
Patients allocated to this arm will be submitted to a placebo intervention (isocaloric supplement plus sham for neuromuscular electrostimulation).
Outcomes
Primary Outcome Measures
Vastus Lateralis Muscle Cross-sectional Area
Vastus Lateralis Muscle Cross-sectional Area will be assessed through ultrasound
Secondary Outcome Measures
Muscle function
Muscle function evaluated trough battery of test
Nutritional status
Nutritional status will be assessed through nutritional records during hospital stay
Handgrip strength
Strength will be evaluated using handgrip strength test
Functional independence
Functional independence will be assessed using Barthel Index
Length of hospital stay
Length of hospital stay will be the time (in days) until medical discharge.
Mortality
Mortality rate in percent
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.
Health costs
Health costs will be estimated by means of the questionnaire with questions about the use of health services or equipment.
Full Information
NCT ID
NCT05008705
First Posted
July 29, 2021
Last Updated
November 1, 2022
Sponsor
University of Sao Paulo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05008705
Brief Title
Protein Intake Plus Neuromuscular Electrical Stimulation on Muscle Mass in Hospitalized Elderly
Official Title
Effects of Protein Intake Plus Neuromuscular Electrical Stimulation on Muscle Mass in Hospitalized Elderly: a Randomized Controlled Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 25, 2021 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophy, Muscular
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Patients allocated to this arm will be submitted to intervention (protein supplementation plus neuromuscular electrostimulation).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients allocated to this arm will be submitted to a placebo intervention (isocaloric supplement plus sham for neuromuscular electrostimulation).
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein supplementation
Intervention Description
Patients will receive diary 2 doses of the protein supplement
Intervention Type
Device
Intervention Name(s)
Neuromuscular electrostimulation.
Intervention Description
Patients will receive diary sessions of neuromuscular electrostimulation.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo (isocaloric supplement)
Intervention Description
Patients will receive diary 2 doses of the isocaloric supplement
Intervention Type
Device
Intervention Name(s)
Sham for neuromuscular electrostimulation.
Intervention Description
Patients will not receive neuromuscular electrostimulation.
Primary Outcome Measure Information:
Title
Vastus Lateralis Muscle Cross-sectional Area
Description
Vastus Lateralis Muscle Cross-sectional Area will be assessed through ultrasound
Time Frame
From date of admission until the date of medical discharge. Up to 30 days.
Secondary Outcome Measure Information:
Title
Muscle function
Description
Muscle function evaluated trough battery of test
Time Frame
From date of admission until the date of medical discharge. Up to 30 days.
Title
Nutritional status
Description
Nutritional status will be assessed through nutritional records during hospital stay
Time Frame
From date of admission until the date of medical discharge. Up to 30 days.
Title
Handgrip strength
Description
Strength will be evaluated using handgrip strength test
Time Frame
From date of admission until the date of medical discharge. Up to 30 days.
Title
Functional independence
Description
Functional independence will be assessed using Barthel Index
Time Frame
From date of admission until the date of medical discharge. Up to 30 days.
Title
Length of hospital stay
Description
Length of hospital stay will be the time (in days) until medical discharge.
Time Frame
From date of admission until the date of medical discharge. Up to 30 days.
Title
Mortality
Description
Mortality rate in percent
Time Frame
From date of admission until the date of medical discharge. Up to 30 days.
Title
Hospital readmission post-medical discharge
Description
Hospital readmission post-medical discharge will be the number of times that he is admitted in the hospital post-medical discharge.
Time Frame
6 months post-medical discharge
Title
Health costs
Description
Health costs will be estimated by means of the questionnaire with questions about the use of health services or equipment.
Time Frame
6 months post-medical discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hamilton Roschel, PhD
Phone
+551130618789
Email
hars@usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamilton Roschel, PhD
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo
City
São Paulo
ZIP/Postal Code
05508-030
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hamilton Roschel, PhD
Phone
+55 11 3061-8789
Email
hars@usp.br
12. IPD Sharing Statement
Plan to Share IPD
No
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Protein Intake Plus Neuromuscular Electrical Stimulation on Muscle Mass in Hospitalized Elderly
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