Health TrialsbyHealthPanel

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

ConditionAtrophy, Muscular
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Sao Paulo General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

both sex;

65 years and older;

hospital stay less than 48 hours;

Disqualifiers

cancer in the last 5 years;

delirium;

cognitive deficit that impossibility the patient to read and sign the informed consent form;

neurological disease;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 2 interventions
Group B: PlaceboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Vastus Lateralis Muscle Cross-sectional Area

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 outcomes

1

Muscle function

Muscle function evaluated trough battery of test

Time frame
From date of admission until the date of medical discharge. Up to 30 days.
2

Nutritional status

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.
3

Handgrip strength

Strength will be evaluated using handgrip strength test

Time frame
From date of admission until the date of medical discharge. Up to 30 days.
4

Functional independence

Functional independence will be assessed using Barthel Index

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Sao Paulo General Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now