SarcopeniaNCT06792201
Evaluation of Sarcopenia in Women in Different Stages of Life and in Hormonal Therapy or Not
A study testing SARC-F, Handgrip test, Chair stand test in people with Sarcopenia, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- SARC-F, Handgrip test, Chair stand test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteItaly
- Study dates
- 14 Jun 2021to 14 Jun 2026
- 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- no exclusion criteria are provided
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria Bologna
Bologna, 40138
Maria C Meriggiola, +390512143716, cristina.meriggiola@unibo.it
About this study
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
Read the detailed description
The present one-center cross-sectional observational study involves the recruitment of 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 the first visit and women in pre-menopause but similar age group compared to the first group.
Patients will be asked to participate in this study during the outpatient follow-up visit.
The study will involve data collection through consultation of health records.
The objectives of the study will therefore be achieved by analysing certain parameters that can be deduced from the medical records of the subjects in the study:
- Collection of anamnestic (eating habits and sports, pathologies of importance, medication intake, previous surgical interventions, smoking habit, gynecological history).
- Physical examination: calculation of BMI, blood pressure measurement, gynecological examination
- Blood tests (blood count, lipid profile, glycemic, liver, kidney, hormonal status) and urine
- Reports of other visits and specialist examinations performed by the patients brought to view during the visit
- During the visit, the following tests will be proposed:
Questionnaire SARC-F Handgrip test Chair stand test bioimpedance Study population
Inclusion criteria:
- Patients attending the O.U. of Gynecology and Human Reproduction Pathophysiology in menopause who take or do not take hormone replacement therapy at the time of the first visit and women in pre-menopause.
- Patients for whom informed consent has been obtained. Exclusion criteria: no exclusion criteria are provided
Visits and evaluations Visits and assessment scheme Each patient will be invited to participate in this study at the usual outpatient checkup according to current clinical practice. Patients will be free to decide whether or not to participate in the study
Information will be collected from the patients attending the U.O. of Gynecology and Pathophysiology of Human Reproduction in menopause who take or do not take hormone replacement therapy at the time of the first visit and women in pre-menopausemenopause but similar age group compared to the first group.
An estimated sample of 180 subjects.
- Conditions
- Sarcopenia
- Being tested
- SARC-F, Handgrip test, Chair stand test
- Keywords
- Sarcopenia, Menopause, Hormonal therapy
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARC-F, Handgrip test, Chair stand testDiagnostic test
Also called Bioimpedance
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: SARC-F, Handgrip test, Chair stand test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment (1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start14 Jun 2021
- Primary completion14 Jun 2025 (estimated)
- Study completion14 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria C Meriggiola, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06792201
- Sponsor's protocol ID
- SARCWOMEN-20
- Status last verified
- Nov 2024
- First submitted
- 30 Dec 2024
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- 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 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sarcopenia in Women in Different Stages of Life and in Hormonal Therapy or Not
- ClinicalTrials.gov ID
- NCT06792201
- Acronym / sponsor ID
- SARCWOMEN-20
- Conditions
- Sarcopenia
- Keywords
- Sarcopenia, Menopause, Hormonal therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 14 Jun 2025 (estimated)
- Study completion
- 14 Jun 2026 (estimated)
- First posted
- 24 Jan 2025 (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.
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
Detailed description
The present one-center cross-sectional observational study involves the recruitment of 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 the first visit and women in pre-menopause but similar age group compared to the first group.
Patients will be asked to participate in this study during the outpatient follow-up visit.
The study will involve data collection through consultation of health records.
The objectives of the study will therefore be achieved by analysing certain parameters that can be deduced from the medical records of the subjects in the study:
- Collection of anamnestic (eating habits and sports, pathologies of importance, medication intake, previous surgical interventions, smoking habit, gynecological history).
- Physical examination: calculation of BMI, blood pressure measurement, gynecological examination
- Blood tests (blood count, lipid profile, glycemic, liver, kidney, hormonal status) and urine
- Reports of other visits and specialist examinations performed by the patients brought to view during the visit
- During the visit, the following tests will be proposed:
Questionnaire SARC-F Handgrip test Chair stand test bioimpedance Study population
Inclusion criteria:
- Patients attending the O.U. of Gynecology and Human Reproduction Pathophysiology in menopause who take or do not take hormone replacement therapy at the time of the first visit and women in pre-menopause.
- Patients for whom informed consent has been obtained. Exclusion criteria: no exclusion criteria are provided
Visits and evaluations Visits and assessment scheme Each patient will be invited to participate in this study at the usual outpatient checkup according to current clinical practice. Patients will be free to decide whether or not to participate in the study
Information will be collected from the patients attending the U.O. of Gynecology and Pathophysiology of Human Reproduction in menopause who take or do not take hormone replacement therapy at the time of the first visit and women in pre-menopausemenopause but similar age group compared to the first group.
An estimated sample of 180 subjects.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intake or not of hormonal therapy of menopause | Other | Diagnostic Test: SARC-F, Handgrip test, Chair stand testThe 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- no exclusion criteria are provided
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 |
|---|---|---|
| SARC-F, Handgrip test, Chair stand testAlso: BioimpedanceThe 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. | Diagnostic test | Intake or not of hormonal therapy of menopause |
Primary outcome
Strength and muscle mass outcomes
Time frame: From enrollment to the end of treatment (1 year)
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.
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 24 Jan 2025.
- 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.
Maria C Meriggiola principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SARC-F, Handgrip test, Chair stand test in people with Sarcopenia, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 2 inclusion and 1 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 24 Jan 2025. 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 Italy. 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. 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 Giulia Gava, MD (0512143716 ext. +39, gava.giulia@hotmail.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strength and muscle mass outcomes (time frame: From enrollment to the end of treatment (1 year)). 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 24 Jan 2025.