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NCT Number: NCT05008705

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

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.

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Key information

Conditions

Atrophy, Muscular Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Protein supplementation

Dietary Supplement

Patients will receive diary 2 doses of the protein supplement

Neuromuscular electrostimulation.

Device

Patients will receive diary sessions of neuromuscular electrostimulation.

Placebo (isocaloric supplement)

Dietary Supplement

Patients will receive diary 2 doses of the isocaloric supplement

Sham for neuromuscular electrostimulation.

Device

Patients will not receive neuromuscular electrostimulation.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  6. Mortality

    Time frame: From date of admission until the date of medical discharge. Up to 30 days.

    Mortality rate in percent

  7. 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.

  8. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hamilton Roschel, PhD

CONTACT

[email protected]

+551130618789

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

Effects of Protein Intake Plus Neuromuscular Electrical Stimulation on Muscle Mass in Hospitalized Elderly: a Randomized Controlled Clinical Study

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Aug 17, 2021
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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