About this trial
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:
1. Does muscle strength contribute to functional health in women aged 45 to 60 years? 2. Does bone mineral density contribute to functional health in women aged 45 to 60 years? 3. How are physical activity, sleep quality, depressive symptoms, body composition, and menopause-related quality of life associated with functional health?
Participants will:
* Undergo handgrip strength measurement * Perform a 30-second chair stand test * Undergo bone mineral density and body composition assessment * Complete questionnaires about physical activity, sleep quality, depressive symptoms, menopausal symptoms, and quality of life * Provide demographic and clinical information
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Women aged 45 to 60 years
Ability to read and complete study questionnaires
Provision of written informed consent
Ability to complete physical performance assessments
Disqualifiers
Acute systemic illness
Active malignancy
Severe neurological or orthopedic impairment limiting physical performance assessment
Cognitive impairment precluding informed consent or questionnaire completion
Trial population
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.
Trial design
Other
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
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).
Hand-Grip Strength measured by hydraulic hand dynamometer (kg)
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.
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.
Total Body Fat Mass measured by BIA (kg)
Total body fat mass (kg) assessed by bioelectrical impedance analysis (BIA).
Other outcomes
Serum 25-Hydroxyvitamin D concentration (nmol/L)
Fasting venous serum 25-hydroxyvitamin D measured by chemiluminescence immunoassay.
Serum Calcium concentration (mmol/L)
Fasting venous serum total calcium measured by colorimetric method.
Serum Phosphorus concentration (mmol/L)
Fasting venous serum inorganic phosphorus measured by colorimetric method.
Serum Parathyroid Hormone (PTH) concentration (pg/mL)
Fasting venous intact PTH measured by electrochemiluminescence immunoassay.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: