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

NCT ID: NCT05008705

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-25

Study Completion Date

2025-11-01

Brief Summary

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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

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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.

Conditions

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Atrophy, Muscular

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Intervention

Patients allocated to this arm will be submitted to intervention (protein supplementation plus neuromuscular electrostimulation).

Group Type EXPERIMENTAL

Protein supplementation

Intervention Type DIETARY_SUPPLEMENT

Patients will receive diary 2 doses of the protein supplement

Neuromuscular electrostimulation.

Intervention Type DEVICE

Patients will receive diary sessions of neuromuscular electrostimulation.

Placebo

Patients allocated to this arm will be submitted to a placebo intervention (isocaloric supplement plus sham for neuromuscular electrostimulation).

Group Type PLACEBO_COMPARATOR

Placebo (isocaloric supplement)

Intervention Type DIETARY_SUPPLEMENT

Patients will receive diary 2 doses of the isocaloric supplement

Sham for neuromuscular electrostimulation.

Intervention Type DEVICE

Patients will not receive neuromuscular electrostimulation.

Interventions

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Protein supplementation

Patients will receive diary 2 doses of the protein supplement

Intervention Type DIETARY_SUPPLEMENT

Neuromuscular electrostimulation.

Patients will receive diary sessions of neuromuscular electrostimulation.

Intervention Type DEVICE

Placebo (isocaloric supplement)

Patients will receive diary 2 doses of the isocaloric supplement

Intervention Type DIETARY_SUPPLEMENT

Sham for neuromuscular electrostimulation.

Patients will not receive neuromuscular electrostimulation.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hamilton Augusto Roschel da Silva

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hamilton Roschel, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo General Hospital

Locations

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University of Sao Paulo

São Paulo, , Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Hamilton Roschel, PhD

Role: CONTACT

Phone: +551130618789

Email: [email protected]

Facility Contacts

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Hamilton Roschel, PhD

Role: primary

Other Identifiers

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CAAE43707021.5.0000.0068

Identifier Type: -

Identifier Source: org_study_id