Atrophy, MuscularNCT05008705
Protein Intake Plus Neuromuscular Electrical Stimulation on Muscle Mass in Hospitalized Elderly
A study testing Protein supplementation and Neuromuscular electrostimulation. in people with Atrophy, Muscular, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Atrophy, Muscular
- What is being tested?
- Protein supplementation and Neuromuscular electrostimulation.
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Aug 2021to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- both sex;
- 65 years and older;
- hospital stay less than 48 hours;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
University of Sao Paulo
São Paulo, 05508-030
Hamilton Roschel, PhD, +55 11 3061-8789, hars@usp.br
About this study
Official title: 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.
Read the 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.
- Conditions
- Atrophy, Muscular
- Being tested
- Protein supplementation, Neuromuscular electrostimulation., Placebo (isocaloric supplement), Sham for neuromuscular electrostimulation.
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein supplementationDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients allocated to this arm will be submitted to intervention (protein supplementation plus neuromuscular electrostimulation). Receives: 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). Receives: Dietary Supplement: Placebo (isocaloric supplement); Device: Sham for neuromuscular electrostimulation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vastus Lateralis Muscle Cross-sectional Area
Vastus Lateralis Muscle Cross-sectional Area will be assessed through ultrasound
Measured: From date of admission until the date of medical discharge. Up to 30 days.
Secondary outcomes (8)
Muscle function
Muscle function evaluated trough battery of test
Measured: From date of admission until the date of medical discharge. Up to 30 days.
Nutritional status
Nutritional status will be assessed through nutritional records during hospital stay
Measured: From date of admission until the date of medical discharge. Up to 30 days.
Handgrip strength
Strength will be evaluated using handgrip strength test
Measured: From date of admission until the date of medical discharge. Up to 30 days.
Functional independence
Functional independence will be assessed using Barthel Index
Measured: From date of admission until the date of medical discharge. Up to 30 days.
Length of hospital stay
Length of hospital stay will be the time (in days) until medical discharge.
Measured: From date of admission until the date of medical discharge. Up to 30 days.
Mortality
Mortality rate in percent
Measured: From date of admission until the date of medical discharge. Up to 30 days.
Hospital readmission post-medical discharge
Hospital readmission post-medical discharge will be the number of times that he is admitted in the hospital post-medical discharge.
Measured: 6 months post-medical discharge
Health costs
Health costs will be estimated by means of the questionnaire with questions about the use of health services or equipment.
Measured: 6 months post-medical discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start25 Aug 2021
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophy, MuscularStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamilton Augusto Roschel da Silva, University of Sao Paulo General Hospital
- Investigators
- Hamilton Roschel, PhD, Principal investigator, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05008705
- Sponsor's protocol ID
- CAAE43707021.5.0000.0068
- Status last verified
- Dec 2024
- First submitted
- 29 Jul 2021
- Last updated
- 5 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Protein Intake Plus Neuromuscular Electrical Stimulation on Muscle Mass in Hospitalized Elderly: a Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT05008705
- Acronym / sponsor ID
- CAAE43707021.5.0000.0068
- Conditions
- Atrophy, Muscular
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 17 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Protein supplementation, Device: Neuromuscular electrostimulation.Patients allocated to this arm will be submitted to intervention (protein supplementation plus neuromuscular electrostimulation). |
| Placebo | Placebo comparator | Dietary Supplement: Placebo (isocaloric supplement), Device: Sham for neuromuscular electrostimulation.Patients allocated to this arm will be submitted to a placebo intervention (isocaloric supplement plus sham for neuromuscular electrostimulation). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- both sex;
- 65 years and older;
- hospital stay less than 48 hours;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protein supplementationPatients will receive diary 2 doses of the protein supplement | Dietary supplement | Intervention |
| Neuromuscular electrostimulation.Patients will receive diary sessions of neuromuscular electrostimulation. | Device | Intervention |
| Placebo (isocaloric supplement)Patients will receive diary 2 doses of the isocaloric supplement | Dietary supplement | Placebo |
| Sham for neuromuscular electrostimulation.Patients will not receive neuromuscular electrostimulation. | Device | Placebo |
Primary outcome
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
8 secondary outcomes
Muscle function
Time frame: 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.
Handgrip strength
Time frame: 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.
Length of hospital stay
Time frame: 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.
Hospital readmission post-medical discharge
Time frame: 6 months post-medical discharge
Health costs
Time frame: 6 months post-medical discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hamilton Roschel, PhD principal investigator
University of Sao Paulo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein supplementation and Neuromuscular electrostimulation. in people with Atrophy, Muscular, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hamilton Roschel, PhD (+551130618789, hars@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vastus Lateralis Muscle Cross-sectional Area (time frame: From date of admission until the date of medical discharge. Up to 30 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024; AzTrials last refreshed its copy on 6 Nov 2026.