Multidimensional Determinants of Functional Health In Women Aged 45-60

NCT07667699 | Not Yet Recruiting

• 1 other identifier: 2026/010.99/26/11
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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:

• 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

Conditions

Healthy; Perimenopausal Depression; Menopausal Complaints; Bone Mineral Density; Sarcopenia; Sleep Quality; Quality of Life

Keywords

Menopause; Perimenopause; Bone mineral density; Sarcopenia; Sleep Quality; Quality of life

Outcome Measures

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).

  Baseline

Secondary Outcomes (14)

• Bone Mineral Density measured by DXA (g/cm²)

  Baseline

• Hand-Grip Strength measured by hydraulic hand dynamometer (kg)

  Baseline

• Lower Extremity Functional Strength assessed by 30-Second Chair Stand Test (number of repetitions)

  Baseline

• Total Body Fat Mass measured by BIA (kg)

  Baseline

• Total Body Fat Percentage measured by BIA (%)

  Baseline

Other Outcomes (15)

• Serum 25-Hydroxyvitamin D concentration (nmol/L)

  Baseline

• Serum Calcium concentration (mmol/L)

  Baseline

• Serum Phosphorus concentration (mmol/L)

  Baseline

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Women aged 45 to 60 years
• Ability to read and complete study questionnaires
• Provision of written informed consent
• Ability to complete physical performance assessments

You may not qualify if:

• Acute systemic illness
• Active malignancy
• Severe neurological or orthopedic impairment limiting physical performance assessment
• Cognitive impairment precluding informed consent or questionnaire completion

Sponsors & Collaborators

• Kartal City Hospital: lead

Related Publications (4)

• 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.

  PMID: 34319208 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.

  PMID: 25982160 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.

  PMID: 10380242 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.

  PMID: 41622331 BACKGROUND

MeSH Terms

Conditions

Sarcopenia; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Study Officials

• Elif Unlugedik Sayın, MD, PhD

  University of Health Sciences, Kartal Dr Lütfi Kırdar City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ELIF UNLUGEDIK SAYIN, MD, PhD

CONTACT

+90 532 234 80 83; elif.unlugedik@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 25, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 25, 2026

Record last verified: 2026-06