Effect of Muscle Stiffness on Vertebral Fractures in Women Over 60
- Conditions
- Osteoporosis in Post-menopausal WomenVertebral Body FracturesBalance, Postural
- Registration Number
- NCT06687889
- Lead Sponsor
- Ankara City Hospital Bilkent
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 54
- Female, aged ≥ 60 years
- History of lumbar spine surgery
- Cancer
- Spinal infection
- Severe degenerative scoliosis
- Chronic kidney failure
- Liver cirrhosis
- Bilateral hip arthroplasty
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Elastography Measurements 8 weeks Measurements were performed using a Mindray ultrasound device (Shenzhen Mindray Biomedical Electronics Co., Ltd., Shenzhen, China) with a 15-3 MHz linear probe in Shear Wave Elastography mode. Ultrasound gel was applied between the probe and the skin to enhance contact. The probe was positioned in line with the muscle fibers and perpendicular to the skin, allowing 2D maps of each muscle's shear modulus to be obtained with a spatial resolution of 1 mm and a sampling rate of 1 sample per second. Images obtained during elastography measurements were analyzed using Q-Box to evaluate Young's modulus (kPa) and SWW (m/s). Shear modulus measurements were taken at rest and at the end of contraction. Muscle thickness measurements were recorded in mm by measuring the distance between the two fascias. All measurements were performed three times, and the average of these measurements will be used for statistical analysis
- Secondary Outcome Measures
Name Time Method Berg balance scale 8 weeks The Berg Balance Scale is a test with proven reliability and validity in Turkish, used to assess balance in the elderly. It consists of 14 items, each scored from 0 to 4 based on observed performance. The maximum score is 56, where 0-20 points indicate balance impairment, 21-40 points suggest acceptable balance, and 41-56 points reflect good balance.
Bone Mineral Density Measurement (DEXA) 8 weeks All participants will undergo bone mineral density (BMD) measurements of the lumbar vertebrae (L1-L4) and left proximal femur (femur neck) at the same center using dual-energy X-ray absorptiometry (DEXA; HOLOGIC, QDR 2000, EXPLORER S1N 90910). Currently, DEXA is the standard method for diagnosing osteoporosis. Osteoporosis and osteopenia are defined according to the criteria set by the World Health Organization (WHO) for postmenopausal women: T-scores of -2.5 or lower indicate osteoporosis, while T-scores between -1.0 and -2.49 represent osteopenia. The T-score reflects bone mass by comparing it to that of a younger individual of the same sex with peak bone mass
Functional Reach Test 8 weeks The Functional Reach Test is a reliable and valid measure of anterior stability . The patient stands close to, but not touching, a wall with their arm extended forward at 90° flexion and fist closed. The evaluator marks the position of the third metacarpal head on the wall. The patient is then asked to reach forward as far as possible without stepping. The evaluator marks the new position of the third metacarpal head, and the difference between the initial and final marks is measured using a tape measure. Three trials are conducted, and the average is recorded. A reach of 15 cm or less indicates a significantly increased fall risk, while 15-25 cm indicates a moderate fall risk.
Timed Up and Go Test 8 weeks This test, with proven reliability and validity, assesses fall risk in the elderly population. The patient is given verbal instructions to stand up from a chair, walk 3 meters following a marked line on the floor as quickly and safely as possible, turn, walk back, and sit down. Times are interpreted as follows: 10 seconds or less-patient walks independently with very low fall risk; 11-19 seconds-patient walks independently with low to moderate fall risk; 20-29 seconds-patient may occasionally need assistance, with moderate to high fall risk; over 30 seconds-patient often needs assistance and has a high fall risk.
Trial Locations
- Locations (1)
Samsun Education and Research Hospital
🇹🇷Samsun, İlkadım, Turkey