Evaluation of Balance and Functionality in Postmenopausal Osteoporosis Using Quadriceps Femoris Muscle Thickness, Beyond Thoracic Hyperkyphosis

NCT06760598 | Completed

• 1 other identifier: E-83045809-604.01.01-439462
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 2

Brief Summary

To determine the impact of thoracic hyperkyphosis, sarcopenia and quadriceps muscle thickness evaluated by ultrasonography (USG) on balance, fall risk and functional parameters in women with postmenopausal osteoporosis, to assess their interrelationships and to compare the clinical characteristics of sarcopenia and thoracic hyperkyphosis.

Conditions

Osteoporosis; Sarcopenia; Ultrasonography; Hyperkyphosis

Keywords

muscle thickness; sarcopenia; hyperkyphosis; ultrasonography

Outcome Measures

Primary Outcomes (6)

• tandem stance and gait test

  static and dynamic balance was measured.

  Data were collected over a single measurement period of 6 months.

• berg balance scale

  Berg balance scale was originally developed for the assessment of postural control and is widely used in many areas of rehabilitation. There are 14 items in the scale, like commonly performing in daily activities sitting and standing balance, transfers, turning, and retrieving objects from the floor. The highest total score is 56 points. If the patient scores between 0-20 points, they are considered wheelchair dependent, between 21-40 points they can walk with assistance and between 41-56 points they are considered independent in mobilization activities.

  Data were collected over a single measurement period of 6 months.

• Timed up and go test

  There is a significant relationship between TUG times and functional mobility level

  Data were collected over a single measurement period of 6 months.

• chair stand test

  The five times CST evaluates the strength, power, and endurance of the lower extremity muscle group, particularly the quadriceps femoris muscle

  Data were collected over a single measurement period of 6 months.

• quadriceps femoris muscle thickness

  evaluated by ultrasound

  Data were collected over a single measurement period of 6 months.

• thoracic kyphosis

  The lateral thoracic vertebra radiographs were taken while standing position, the Cobb angle was automatically obtained by computer-aided method by marking the parallel lines drawn from the upper edge of the upper thoracic vertebra (T4), and the lower edge of the lower thoracic vertebra (T12)

  Data were collected over a single measurement period of 6 months.

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: Women with Postmenopausal Osteoporosis
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 50 years and over with postmenopausal osteoporosis and/or osteoporotic vertebral fractures according to WHO criteria who applied to the outpatient clinic of the Department of Physical Medicine and Rehabilitation, Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine

You may qualify if:

• Patient who were 50 years of age or older, had postmenopausal osteoporosis and/or osteoporotic vertebral fractures according to WHO criteria,
• Patient who were able to ambulate without any assistive devices

You may not qualify if:

• History of neurological disease which may affect balance and proprioception,
• Visual and vestibular disease
• Previous major lower extremity surgery or previous vertebra surgery
• Advanced heart, liver, or renal failure
• Stage 4 knee osteoarthritis
• Psychiatric disorders
• Use of any medication affecting the central nervous system.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (2)

Istanbul University Cerrahpasa

Istanbul, Istanbul, 59030, Turkey (Türkiye)

Location

Istanbul University Cerrahpasa, Cerrahpasa Medical Faculty

Istanbul, SÜLEYMANPAŞA, 59030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoporosis; Sarcopenia; Kyphosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Spinal Curvatures; Spinal Diseases

Study Officials

• ESLEM PEKER BELENE

  Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty

  PRINCIPAL INVESTIGATOR

• ZEYNEP ÜLKÜ AKARIRMAK

  Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty

  STUDY DIRECTOR

• RANA TERLEMEZ

  Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty

  STUDY CHAIR

• OSMAN AYKAN KARGIN

  Istanbul University- Cerrahpasa, Cerrahpasa Medical Faculty

  STUDY CHAIR

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: Medical Doctor

Study Record Dates

• First Submitted: December 27, 2024
• First Posted: January 7, 2025
• Study Start: July 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: November 29, 2023
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 12 months after publication of primary results
• Access Criteria: Academic and Clinical Researchers, Regulatory Authorities and Non-commercial Researchers and Public Health Organizations can access the data Demographic and Clinical Data, Outcome Measures,Study protocols, statistical analysis plans, and publications can be accessed Submit a Request, Approval Process, Secure Access will be accessed

Locations

TU (2)