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

NCT05008705 | Recruiting

• 1 other identifier: CAAE43707021.5.0000.0068
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrophy, Muscular

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Muscle function

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

• Nutritional status

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

• Handgrip strength

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

• Functional independence

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

• Length of hospital stay

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

Study Arms (2)

Intervention

EXPERIMENTAL

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

Dietary Supplement: Protein supplementation; Device: Neuromuscular electrostimulation.

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo (isocaloric supplement); Device: Sham for neuromuscular electrostimulation.

Interventions

Protein supplementation DIETARY_SUPPLEMENT

Patients will receive diary 2 doses of the protein supplement

Intervention

Neuromuscular electrostimulation. DEVICE

Patients will receive diary sessions of neuromuscular electrostimulation.

Intervention

Placebo (isocaloric supplement) DIETARY_SUPPLEMENT

Patients will receive diary 2 doses of the isocaloric supplement

Placebo

Sham for neuromuscular electrostimulation. DEVICE

Patients will not receive neuromuscular electrostimulation.

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• both sex;
• years and older;
• hospital stay less than 48 hours;

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

University of Sao Paulo

São Paulo, 05508-030, Brazil

RECRUITING

MeSH Terms

Conditions

Muscular Atrophy

Condition Hierarchy (Ancestors)

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

Study Officials

• Hamilton Roschel, PhD

  University of Sao Paulo General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hamilton Roschel, PhD

CONTACT

+551130618789; hars@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 17, 2021
• Study Start: August 25, 2021
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)