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The goal of this observational study is to learn about the multidimensional determinants of functional health in women aged 45 to 60 years. The study will focus on the role of muscle strength, bone mineral density, body composition, physical activity, sleep quality, depressive symptoms, and menopause-related symptoms in functional health.
The main questions it aims to answer are:
Participants will:
This is a single-center, cross-sectional observational study designed to evaluate the multidimensional determinants of functional health in women aged 45 to 60 years. The study will be conducted at the Department of Obstetrics and Gynecology, Kartal Dr. Lütfi Kırdar City Hospital, Istanbul, Turkey.
Midlife and the menopausal transition are associated with changes in muscle strength, bone mineral density, body composition, metabolic profile, physical performance, sleep quality, mood, and menopause-related symptoms. Functional health is a multidimensional construct encompassing physical capacity, independence in daily activities, psychological well-being, and health-related quality of life. This study will assess functional health using biological, behavioral, psychological, and symptom-related indicators rather than relying on a single test or questionnaire score.
Inclusion Criteria are:
Exclusion Criteria are:
Muscle strength and physical performance will be assessed using handgrip strength measurement with a dynamometer and the 30-second chair stand test. Anthropometric measurements, including body weight and waist circumference, will be obtained. Body composition will be assessed using a bioelectrical impedance analysis device.
Bone health will be evaluated using dual-energy X-ray absorptiometry data. Existing bone mineral density data obtained within the previous 6 months will be used, and no repeat DXA assessment will be carried out. Laboratory parameters include complete blood count, 25-hydroxyvitamin D, vitamin B12, ferritin, liver function tests, lipid profile, glucose-related parameters, HbA1c, and/or HOMA-IR.
Participants will complete validated questionnaires assessing physical activity, vulvovaginal symptoms, menopausal symptoms, menopause-specific quality of life, general health-related quality of life, depressive symptoms, and sleep quality. The questionnaires planned for use include the International Physical Activity Questionnaire-Short Form, Vulvovaginal Symptoms Questionnaire, Menopause Rating Scale, Menopause-Specific Quality of Life Questionnaire-II, SF-36 Health Survey, Beck Depression Inventory, and Pittsburgh Sleep Quality Index.
Data will be collected using standardized case report forms. Questionnaire forms will be provided by the principal investigator and completed by the participants during the study visit. Physical performance tests will be performed in the outpatient clinic by the principal investigator. Body composition measurements will be performed by the co-investigator.
Data quality will be supported by predefined study variables, standardized data-collection forms, and consistency checks during data entry. The database will be reviewed for missing, out-of-range, or inconsistent values. When a variable is unavailable in the medical record, it will be coded as missing. No imputation is planned for unavailable variables; analyses will be conducted using available data, and the number of participants included in each analysis will be reported.
Approximately 200 women are planned for inclusion. This sample size was selected to allow multivariable analyses and structural equation modeling. The planned model is expected to include approximately 15 to 20 observed variables and 20 to 25 free parameters. A minimum sample size of approximately 180 participants was estimated based on the recommended ratio of participants to free parameters in structural equation modeling. Therefore, enrollment of at least 200 participants is planned to improve model stability and allow reliable estimation of model fit indices.
Descriptive statistics will be used to summarize demographic, clinical, functional, densitometric, laboratory, and questionnaire-based variables. Associations between variables will be evaluated using correlation analyses and multivariable regression models. Age, body mass index, menopausal duration, and comorbidities will be considered as covariates. Statistical significance will be set at p < 0.05. Structural equation modeling will be used to examine the structural relationships among muscle health, bone health, body composition, physical activity, sleep quality, depressive symptoms, menopausal symptoms, and functional health.
The study is expected to provide a multidimensional model of functional health in women aged 45 to 60 years and to clarify the independent contribution of muscle and bone health to functional capacity and health-related quality of life during midlife.
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| Measure | Description | Time Frame |
|---|---|---|
| Physical Functional Performance Score assessed by 30-Second Chair Stand Test and Hand-Grip Dynamometry (composite z-score) | Functional performance will be operationalised as a composite of two validated measures: (1) number of repetitions completed in the 30-second chair stand test as a measure of lower extremity strength, and (2) dominant hand grip strength (kg) will be measured by calibrated hydraulic hand dynamometer following EWGSOP2 protocol. A standardised composite functional performance z-score will be derived by summing the z-scores of both measures. The primary analysis will examine the independent contributions of bone mineral density and skeletal muscle mass to this composite score using multivariable linear regression and structural equation modelling (SEM). | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Bone Mineral Density measured by DXA (g/cm²) | Lumbar spine (L1-L4) and Femoral neck areal BMD (g/cm²) will be measured by dual-energy X-ray absorptiometry (DXA). The values will be compared across three age subgroups (45-50, 50-55, 55-60 years). | Baseline |
| Hand-Grip Strength measured by hydraulic hand dynamometer (kg) |
| Measure | Description | Time Frame |
|---|---|---|
| Serum 25-Hydroxyvitamin D concentration (nmol/L) | Fasting venous serum 25-hydroxyvitamin D measured by chemiluminescence immunoassay. | Baseline |
| Serum Calcium concentration (mmol/L) | Fasting venous serum total calcium measured by colorimetric method. |
Inclusion Criteria are:
Exclusion Criteria are:
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The study population will be drawn from women attending the Obstetrics and Gynecology outpatient clinic of Kartal Dr. Lütfi Kırdar City Hospital, Istanbul, Turkey. Participants will be identified among patients presenting for routine outpatient gynecologic care and will undergo study-specific assessments during a single outpatient visit.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ELIF UNLUGEDIK SAYIN, MD, PhD | Contact | +90 532 234 80 83 | elif.unlugedik@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Elif Unlugedik Sayın, MD, PhD | University of Health Sciences, Kartal Dr Lütfi Kırdar City Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34319208 | Background | Lorentzon M, Johansson H, Harvey NC, Liu E, Vandenput L, McCloskey EV, Kanis JA. Osteoporosis and fractures in women: the burden of disease. Climacteric. 2022 Feb;25(1):4-10. doi: 10.1080/13697137.2021.1951206. Epub 2021 Jul 28. | |
| 25982160 | Background | Leong DP, Teo KK, Rangarajan S, Lopez-Jaramillo P, Avezum A Jr, Orlandini A, Seron P, Ahmed SH, Rosengren A, Kelishadi R, Rahman O, Swaminathan S, Iqbal R, Gupta R, Lear SA, Oguz A, Yusoff K, Zatonska K, Chifamba J, Igumbor E, Mohan V, Anjana RM, Gu H, Li W, Yusuf S; Prospective Urban Rural Epidemiology (PURE) Study investigators. Prognostic value of grip strength: findings from the Prospective Urban Rural Epidemiology (PURE) study. Lancet. 2015 Jul 18;386(9990):266-73. doi: 10.1016/S0140-6736(14)62000-6. Epub 2015 May 13. |
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The decision to share individual participant data has not yet been finalized. The study includes clinical, questionnaire-based, functional, densitometric, and laboratory data obtained from outpatient assessments and hospital records. Any future data sharing would be limited to de-identified data and would require appropriate ethical and institutional approval.
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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Dominant hand grip strength (kg) will be measured by calibrated hydraulic hand dynamometer following EWGSOP2 protocol. Among the three trials performed; mean value will be recorded. |
| Baseline |
| Lower Extremity Functional Strength assessed by 30-Second Chair Stand Test (number of repetitions) | Number of full sit-to-stand repetitions completed within 30 seconds without arm support, following standardised protocol. | Baseline |
| Total Body Fat Mass measured by BIA (kg) | Total body fat mass (kg) assessed by bioelectrical impedance analysis (BIA). | Baseline |
| Total Body Fat Percentage measured by BIA (%) | Total body fat percentage (%) assessed by bioelectrical impedance analysis (BIA). | Baseline |
| Fat-Free Mass measured by BIA (kg) | Total fat-free mass (kg) assessed by bioelectrical impedance analysis (BIA). | Baseline |
| Skeletal Muscle Mass measured by BIA (kg) | Appendicular and total skeletal muscle mass (kg) assessed by bioelectrical impedance analysis (BIA). | Baseline |
| Total Body Water measured by BIA (litres) | Total body water (litres) assessed by bioelectrical impedance analysis (BIA). | Baseline |
| Body Mass Index (BMI) calculated from measured height and weight (kg/m²) | Body weight (kg) and height (cm) is measured by standardised anthropometry; BMI will be calculated as weight divided by height squared (kg/m²). | Baseline |
| Physical Component Summary Score of SF-36 (units on a scale 0-100) | Physical Component Summary (PCS) score derived from the validated Turkish version of the Short Form-36 (SF-36) questionnaire. Score range 0-100; higher scores indicate better physical health-related quality of life. | Baseline |
| Mental Component Summary Score of SF-36 (units on a scale 0-100) | Mental Component Summary (MCS) score derived from the validated Turkish version of the SF-36. Score range 0-100; higher scores indicate better mental health-related quality of life. | Baseline |
| Menopause-Specific Quality of Life (MENQOL) Total Score (units on a scale 1-8) | Total score from the validated Turkish version of the Menopause-Specific Quality of Life Questionnaire (MENQOL), a 29-item instrument. Score range 1-8 per item; higher scores indicate greater symptom burden across vasomotor, psychosocial, physical, and sexual domains. | Baseline |
| Global Sleep Quality Score assessed by Pittsburgh Sleep Quality Index - PSQI (units on a scale 0-21) | Global PSQI score from the validated Turkish version of the Pittsburgh Sleep Quality Index. Score range 0-21; scores above 5 indicate poor sleep quality. | Baseline |
| Physical Activity Level assessed by IPAQ-Short Form (MET-minutes per week) | Total weekly physical activity expressed as metabolic equivalent of task minutes per week (MET-min/week), calculated from the validated Turkish version of the International Physical Activity Questionnaire - Short Form (IPAQ-SF). | Baseline |
| Baseline |
| Serum Phosphorus concentration (mmol/L) | Fasting venous serum inorganic phosphorus measured by colorimetric method. | Baseline |
| Serum Parathyroid Hormone (PTH) concentration (pg/mL) | Fasting venous intact PTH measured by electrochemiluminescence immunoassay. | Baseline |
| Serum Alkaline Phosphatase (ALP) activity (U/L) | Fasting venous serum ALP measured as a marker of bone and liver metabolic activity. | Baseline |
| Serum Osteocalcin concentration - bone formation marker (ng/mL) | Fasting venous serum osteocalcin measured by immunoassay as a marker of osteoblast activity. | Baseline |
| Fasting Plasma Glucose concentration (mg/dL) | Venous fasting plasma glucose measured by enzymatic colorimetric method after minimum 8-hour fast. | Baseline |
| Glycated Haemoglobin (HbA1c) (%) | HbA1c measured by high-performance liquid chromatography (HPLC) as an index of 3-month glycaemic control. | Baseline |
| Fasting Serum Insulin concentration (µIU/mL) | Fasting venous serum insulin measured by electrochemiluminescence immunoassay. | Baseline |
| Serum Total Cholesterol concentration (mg/dL) | Fasting venous serum total cholesterol measured by enzymatic colorimetric method. | Baseline |
| Serum LDL Cholesterol concentration (mg/dL) | : Fasting venous serum LDL cholesterol measured by direct homogeneous assay | Baseline |
| Serum HDL Cholesterol concentration (mg/dL) | Fasting venous serum HDL cholesterol measured by direct homogeneous assay. | Baseline |
| Serum Triglycerides concentration (mg/dL) | Fasting venous serum triglycerides measured by enzymatic colorimetric method after minimum 8-hour fast. | Baseline |
| Serum Follicle-Stimulating Hormone (FSH) concentration (mIU/mL) | Fasting venous serum FSH measured by electrochemiluminescence immunoassay as an endocrine indicator of menopausal transition stage. | Baseline |
| Serum Estradiol (E2) concentration (pg/mL) | Fasting venous serum estradiol measured by electrochemiluminescence immunoassay. | Baseline |
| 10380242 | Background | Jones CJ, Rikli RE, Beam WC. A 30-s chair-stand test as a measure of lower body strength in community-residing older adults. Res Q Exerc Sport. 1999 Jun;70(2):113-9. doi: 10.1080/02701367.1999.10608028. |
| 41622331 | Background | Geraldi MV, Brattemark E, Lorentzon M. Longitudinal associations of dietary intake, physical activity, and short-chain fatty acids with bone development in early postmenopausal women. Osteoporos Int. 2026 Apr;37(4):879-892. doi: 10.1007/s00198-026-07861-6. Epub 2026 Feb 2. |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D001523 | Mental Disorders |