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

NCT06792201 | Recruiting

• 1 other identifier: SARCWOMEN-20
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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

Sarcopenia

Keywords

Sarcopenia; Menopause; Hormonal therapy

Outcome Measures

Primary Outcomes (1)

• Strength and muscle mass outcomes

  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 will be used for this purpose.

  From enrollment to the end of treatment (1 year)

Study Arms (1)

Intake or not of hormonal therapy of menopause

OTHER

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

Diagnostic Test: SARC-F, Handgrip test, Chair stand test

Interventions

SARC-F, Handgrip test, Chair stand test DIAGNOSTIC_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.

Also known as: Bioimpedance

Intake or not of hormonal therapy of menopause

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients attending the O.U. of Gynecology and Pathophysiology of Human Reproduction in menopause who take or do not take hormone replacement therapy at the time of visit as normal clinical practice and women in pre-menopause.
• Patients for whom informed consent has been obtained.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria Bologna

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Maria C Meriggiola

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giulia Gava, MD

CONTACT

0512143716; gava.giulia@hotmail.it

Maria C Meriggiola, MD

CONTACT

0512143716; cristina.meriggiola@unibo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 24, 2025
• Study Start: June 14, 2021
• Primary Completion: June 14, 2025
• Study Completion: June 14, 2026
• Last Updated: January 24, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)