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

December 3, 2024 updated by: Hamilton Augusto Roschel da Silva, University of Sao Paulo General Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hamilton Roschel, PhD
  • Phone Number: +551130618789
  • Email: hars@usp.br

Study Locations

  • Brazil
      • São Paulo, Brazil, 05508-030
        • Recruiting
        • University of Sao Paulo
        • Contact:
          • Hamilton Roschel, PhD
          • Phone Number: +55 11 3061-8789
          • Email: hars@usp.br

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Patients allocated to this arm will be submitted to intervention (protein supplementation plus neuromuscular electrostimulation).
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.
Placebo Comparator: Placebo
Patients allocated to this arm will be submitted to a placebo intervention (isocaloric supplement plus sham for 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vastus Lateralis Muscle Cross-sectional Area
Time Frame: 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
From date of admission until the date of medical discharge. Up to 30 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle function
Time Frame: From date of admission until the date of medical discharge. Up to 30 days.
Muscle function evaluated trough battery of test
From date of admission until the date of medical discharge. Up to 30 days.
Nutritional status
Time Frame: 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
From date of admission until the date of medical discharge. Up to 30 days.
Handgrip strength
Time Frame: From date of admission until the date of medical discharge. Up to 30 days.
Strength will be evaluated using handgrip strength test
From date of admission until the date of medical discharge. Up to 30 days.
Functional independence
Time Frame: From date of admission until the date of medical discharge. Up to 30 days.
Functional independence will be assessed using Barthel Index
From date of admission until the date of medical discharge. Up to 30 days.
Length of hospital stay
Time Frame: 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.
From date of admission until the date of medical discharge. Up to 30 days.
Mortality
Time Frame: From date of admission until the date of medical discharge. Up to 30 days.
Mortality rate in percent
From date of admission until the date of medical discharge. Up to 30 days.
Hospital readmission post-medical discharge
Time Frame: 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.
6 months post-medical discharge
Health costs
Time Frame: 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.
6 months post-medical discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Hamilton Roschel, PhD, University of Sao Paulo General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2021

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

July 29, 2021

First Submitted That Met QC Criteria

August 9, 2021

First Posted (Actual)

August 17, 2021

Study Record Updates

Last Update Posted (Estimated)

December 5, 2024

Last Update Submitted That Met QC Criteria

December 3, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE43707021.5.0000.0068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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