Evaluation of Sarcopenia in Women in Different Stages of Life and in Hormonal Therapy or Not
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Strength and muscle mass outcomes
研究概览
简要总结
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
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •no exclusion criteria are provided
研究组 & 干预措施
Intake or not of hormonal therapy of menopause
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
干预措施: SARC-F, Handgrip test, Chair stand test (Diagnostic Test)
结局指标
主要结局
Strength and muscle mass outcomes
时间窗: 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.
次要结局
未报告次要终点