Sarcopenia
Conditions
Interventions
This is a randomized, controlled, two-arm, double-blind clinical trial. It will have a total of 128 participants divided into two groups: the Intervention Group, which will perform physical exercises
G11.427.410.698.277
Sponsors
Universidade Federal do Amapá
Hospital Universitário da Universidade Federal do Amapá
Eligibility
Age
65 Years to 80 Years
Inclusion criteria
Inclusion criteria: Individuals between 65 and 80 years old; With a SARC-CalF score > or = 11 points, suggestive of sarcopenia (Barbosa-Silva et al, 2016); • Minimum score on the Mini Mental State Examination > 24 points; • Capacity to consent: ability to provide written informed consent; • Medication stability: participants who are on a stable medication regimen (no changes in the last 4 weeks before the start of the study), if during the follow-up they require a substantial change in the medication regimen, the participant may be excluded.
Exclusion criteria
Exclusion criteria: Serious medical conditions: Individuals with serious medical conditions that could interfere with safe participation in the study or interpretation of the results, such as unstable heart disease, severe renal or hepatic impairment. Supplement use: Use of other nutraceutical supplements or changes in usual supplementation in the last 4 weeks before the start of the study. Neurological diseases that affect mobility or muscle strength. Active cancer: Patients diagnosed with active cancer or undergoing treatment for cancer in the last 5 years. Recent dietary changes: Significant changes in diet in the last 3 months. Participation in other studies: Participation in other clinical studies in the last 6 months. Individuals who perform intense physical activity or strength training regularly (more than 3 times per week) in the last three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in muscle strength, assessed by palmar grip with an increase of at least 5 kgf compared to the control group 48 hours after the end of the intervention protocol | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in functionality, assessed by the gait speed test with an increase of at least 0.1 m/s compared to the control group 48 hours after the end of the intervention protocol;Improvement in quality of life, assessed by the WHOQOL-OLD test with an increase of at least 0.5 points, compared to the control group 48 hours after the end of the intervention protocol;Safety in use, assessed by the adverse event record diary with an acceptable value of up to 10% risk. | — |
Countries
Brazil
Contacts
Public ContactIgor Silva
Hospital Universitário da Universidade Federal do Amapá
Outcome results
None listed