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Evaluation of Sarcopenia in Women in Different Stages of Life and in Hormonal Therapy or Not

NCT06792201 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-01-24

No results posted yet for this study

Summary

The three-year interventional study has the following objectives:

The study aims to assess the prevalence of sarcopenia in menopausal women receiving hormone replacement therapy or not compared with pre-menopausal women. The study population will be divided into groups according to the intake or not of hormonal therapy of menopause as per normal clinical practice and the menopausal state:

GROUP A - menopausal patient taking hormone therapy GROUP B - menopausal patient not taking hormone therapy GROUP C - pre-menopausal patients who do not take hormonal products The primary objective is to compare the strength and muscle mass outcomes of HRT in menopausal women compared with those who do not use it and women in pre-menopausal age. Survey methods such as SARC-F, Handgrip test, Chair stand test and bio impedance

Conditions

Interventions

DIAGNOSTIC_TEST

SARC-F, Handgrip test, Chair stand test

The SARC-F questionnaire is a simple to use questionnaire consisting of five questions about daily actions.To test the force will be used: Hand-grip test and Chair stand test. The tool used for the hand-grip test is the GRIP-A (Takei). The test is performed on the dominant limb and repeated three times. The position taken by the patient will be: sitting with shoulders and elbows flexed, forearms in neutral position. The Chair stand test measures the time it takes for a patient to get up five times from a sitting position without the help of her upper limbs. The test will be timed.The measurement of lean mass will be carried out by means of a bio impedance meter. This instrument does not measure muscle mass directly but estimates it based on the electrical conductivity of the whole body. Bioimpedance is a method that is easy and safe for the patient to use.

Sponsors & Collaborators

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Principal Investigators

  • Maria C Meriggiola · IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-14
Primary Completion
2025-06-14
Completion
2026-06-14

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06792201 on ClinicalTrials.gov