Multidimensional Determinants of Functional Health In Women Aged 45-60

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age45-60
SponsorKartal City Hospital

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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).

Time frame
Baseline

Secondary outcomes

1

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).

Time frame
Baseline
2

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.

Time frame
Baseline
3

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.

Time frame
Baseline
4

Total Body Fat Mass measured by BIA (kg)

Total body fat mass (kg) assessed by bioelectrical impedance analysis (BIA).

Time frame
Baseline

Other outcomes

1

Serum 25-Hydroxyvitamin D concentration (nmol/L)

Fasting venous serum 25-hydroxyvitamin D measured by chemiluminescence immunoassay.

Time frame
Baseline
2

Serum Calcium concentration (mmol/L)

Fasting venous serum total calcium measured by colorimetric method.

Time frame
Baseline
3

Serum Phosphorus concentration (mmol/L)

Fasting venous serum inorganic phosphorus measured by colorimetric method.

Time frame
Baseline
4

Serum Parathyroid Hormone (PTH) concentration (pg/mL)

Fasting venous intact PTH measured by electrochemiluminescence immunoassay.

Time frame
Baseline

Locations

This trial has no locations.

Sponsors and contacts

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