Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05008705
Other study ID # CAAE43707021.5.0000.0068
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 25, 2021
Est. completion date November 1, 2024

Study information

Verified date November 2023
Source University of Sao Paulo General Hospital
Contact Hamilton Roschel, PhD
Phone +551130618789
Email hars@usp.br
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date November 1, 2024
Est. primary completion date November 1, 2024
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Protein supplementation
Patients will receive diary 2 doses of the protein supplement
Device:
Neuromuscular electrostimulation.
Patients will receive diary sessions of neuromuscular electrostimulation.
Dietary Supplement:
Placebo (isocaloric supplement)
Patients will receive diary 2 doses of the isocaloric supplement
Device:
Sham for neuromuscular electrostimulation.
Patients will not receive neuromuscular electrostimulation.

Locations

Country Name City State
Brazil University of Sao Paulo São Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Muscle function Muscle function evaluated trough battery of test From date of admission until the date of medical discharge. Up to 30 days.
Secondary Nutritional status Nutritional status will be assessed through nutritional records during hospital stay From date of admission until the date of medical discharge. Up to 30 days.
Secondary Handgrip strength Strength will be evaluated using handgrip strength test From date of admission until the date of medical discharge. Up to 30 days.
Secondary Functional independence Functional independence will be assessed using Barthel Index From date of admission until the date of medical discharge. Up to 30 days.
Secondary Length of hospital stay Length of hospital stay will be the time (in days) until medical discharge. From date of admission until the date of medical discharge. Up to 30 days.
Secondary Mortality Mortality rate in percent From date of admission until the date of medical discharge. Up to 30 days.
Secondary 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. 6 months post-medical discharge
Secondary Health costs Health costs will be estimated by means of the questionnaire with questions about the use of health services or equipment. 6 months post-medical discharge
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05670080 - Does MI Have a Therapeutic Role in Arthroscopic Rotator Cuff Repair? N/A
Recruiting NCT04436523 - Blood Flow Restriction After Meniscus Repair N/A
Completed NCT00964340 - A Clinical Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral SRT2104 Capsules Administered to Healthy Elderly Subjects for 28 Days Phase 1
Not yet recruiting NCT05093985 - Blood Flow Restricted Electrical Stimulation During Immobilisation N/A
Not yet recruiting NCT04861857 - Effects of Parmigiano Reggiano on Muscle and Inflammatory Response to Eccentric Resistance Training in Older Adults N/A
Recruiting NCT05776862 - Study Testing Benefits of Ursolic Acid (UA) as a Countermeasure To Myopenia and Insulin Resistance in Chronic Spinal Cord Injury (SCI) Phase 2
Withdrawn NCT01039909 - A Clinical Study to Assess the Effects of SRT2104 Upon Immobilization-Induced Skeletal Muscle Atrophy in Healthy Human Volunteers Phase 1
Completed NCT05773469 - Energy Balance in Extreme Environments: Finding the EI Limit
Withdrawn NCT06032247 - Bilateral Versus Unilateral Strength Training After ACLR N/A
Not yet recruiting NCT05760066 - Effects of Resistance Training Preconditioning on Skeletal Muscle Recovery From a Period of Disuse in Young Adults N/A
Completed NCT01476072 - 31P MRS Ischaemic Exercise Optimisation and COPD Phase 1