Clinical trial NCT06687889: Effect of Muscle Stiffness on Vertebral Fractures in Women Over 60
Official title: The Effect of Abdominal and Lumbar Muscle Stiffness Assessed by Elastography on Vertebral Fractures: a Cross-Sectional Study in Women Over 60
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoporosis in Post-menopausal Women
Vertebral Body Fractures
Balance, Postural
Keywords: vertebral fractures
osteoporosis
abdominal muscles
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
Collaborators: name: Samsun Education and Research Hospital
First posted: 2024-11-14
Enrollment: 54
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Female, aged ≥ 60 years

Brief summary: This study aims to assess the quality of lumbar and abdominal core muscles through elastography and evaluate its impact on vertebral fracture risk. This tudy's secondary objective is to investigate the relationship between muscle quality, as measured by elastography, and balance and quality of life.

The fundamental questions that this study aims to answer are as follows:

Does the quality of lumbar and abdominal core muscles, as assessed by elastography, affect the risk of vertebral fractures? Is there a relationship between muscle quality (as measured by elastography) and balance and quality of life in older adults?

Detailed description: Osteoporosis, a systemic bone disease marked by reduced bone mass and deteriorating bone structure, increases fracture risk, especially in the spine. Vertebral fractures, most common in the lower thoracic and upper lumbar regions, can impair motor function, limit daily activities, and raise disability and mortality risks. With aging, decreasing bone mineral density (BMD) and muscle quality contribute to structural changes like kyphosis and lordosis, further reducing balance and increasing fracture risk. While DEXA remains the standard for BMD assessment, ultrasound (USG) and shear wave elastography (SWE) offer non-invasive imaging for muscle quality without radiation exposure. Despite muscle degeneration's impact on spinal stability, most osteoporosis studies focus on bones, with few examining muscles. Recognizing this gap, our study uses elastography to assess lumbar and abdominal muscle quality and its impact on vertebral fracture risk, while also exploring the relationship between muscle quality, balance, and quality of life in older adults.

Eligibility criteria: Inclusion Criteria:

* Female, aged ≥ 60 years

Exclusion Criteria:

* History of lumbar spine surgery
* Cancer
* Spinal infection
* Severe degenerative scoliosis
* Chronic kidney failure
* Liver cirrhosis
* Bilateral hip arthroplasty

Primary outcomes:
measure: Elastography Measurements
timeFrame: 8 weeks
Secondary outcomes:
measure: Bone Mineral Density Measurement (DEXA)
timeFrame: 8 weeks
measure: Berg balance scale
timeFrame: 8 weeks
measure: Functional Reach Test
timeFrame: 8 weeks
measure: Timed Up and Go Test
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Samsun Education and Research Hospital
state: İlkadım
Study officials:
References:
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