AzTrials
AzTrials

Older Adults (60 - 85 Years Old)NCT07866807

Evaluation of Sarcopenia and Muscle Biomechanics in Older Adults After Lumbar Fusion Surgery

An observational study of Older Adults (60 - 85 Years Old) and Sarcopenia, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Abstract Background: Lumbar fusion (LF) surgery successfully restores the mechanical stability of the spine; however, postoperative kinesiophobia and complications can trigger secondary sarcopenia. Read more about this study

Who is it for?
Ages 18 to 80 years
How many people
51 participants
Where
1 siteTurkey (Türkiye)
Study dates
5 Jan 2026to 1 Oct 2026
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: This single-center, prospective, comparative, cross-sectional study included 56 older patients with lumbar spinal stenosis. It comprised 31 patients with a history of lumbar fusion (LF) surgery and a control group of 25 patients undergoing conservative treatment, matched for age and body mass index.

Who may be able to join

  • Age 18 years or older,
  • History of chronic low back pain,
  • History of multilevel LF surgery performed at least one month prior (to exclude the acute postoperative inflammatory phase).
  • Age 18 years or older
  • History of chronic low back pain.

Who cannot join

  • Morbid obesity (BMI > 40 kg/m²)
  • Systemic and metabolic diseases: Uncontrolled hypertension, diabetes mellitus, hyperlipidemia, and congestive heart failure.
  • Neuromuscular and cognitive disorders: Central or peripheral neurological diseases affecting muscle tone or mobility (e.g., Parkinson's disease, hemiplegia, multiple sclerosis, and other neurodegenerative disorders),
  • Nutritional and systemic factors: Conditions such as active malignancy, malabsorption syndromes, or clinical malnutrition that directly lead to systemic cachexia or loss of muscle mass, independent of postoperative immobility.
  • Prolonged immobilization or strict bed rest lasting longer than one week (for reasons unrelated to the LF surgical protocol); visual, auditory, or literacy impairments that hinder the ability to complete performance tests (e.g., gait speed, chair-stand test) or clinical questionnaires.
  • Pregnancy.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Karamanoglu Mehmetbey University

    Karaman

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of Sarcopenia and Muscle Biomechanics in Older Adults After Lumbar Fusion Surgery: A Cross-sectional Controlled Study Based on Ultrasound and Digital Myotonometry

Abstract Background: Lumbar fusion (LF) surgery successfully restores the mechanical stability of the spine; however, postoperative kinesiophobia and complications can trigger secondary sarcopenia. Conventional diagnostic algorithms focus on muscle mass and active strength, leading to the neglect of passive viscoelastic alterations in muscle tissue. This study aimed to investigate the prevalence of secondary sarcopenia and changes in in vivo muscle biomechanics in patients undergoing LF surgery, using ultrasonography and digital myotonometry methods.

Methods: This single-center, prospective, comparative, cross-sectional study included 56 older patients with lumbar spinal stenosis. It comprised 31 patients with a history of lumbar fusion (LF) surgery and a control group of 25 patients undergoing conservative treatment, matched for age and body mass index. Sarcopenia staging was performed using ISarcoPRM and EWGSOP2 diagnostic criteria. Appendicular muscle mass was measured via the ultrasound-based "Sonographic Thigh Adjustment Ratio" (STAR). The passive viscoelastic properties of the rectus femoris (RF), tibialis anterior, medial gastrocnemius, and lumbar extensor muscles were assessed using a handheld digital myotonometer.

Read the detailed description

This study is designed as a single-center, prospective, comparative cross-sectional investigation to evaluate the prevalence of secondary sarcopenia and alterations in passive muscle biomechanics among patients with a history of multilevel lumbar decompression and fusion (LF) surgery for lumbar spinal stenosis (LSS). To delineate long-term musculoskeletal adaptations associated with surgical intervention, findings are compared against an age- and body mass index (BMI)-matched control cohort of LSS patients managed exclusively with conservative therapy.

Following screening and enrollment at the outpatient Physical Medicine and Rehabilitation clinics, eligible participants undergo standardized evaluations in a temperature-controlled environment (22-24°C) after a 15-minute resting acclimatization period to ensure complete neuromuscular relaxation. Assessments follow a multi-step sequence:

Sarcopenia Screening and Functional Stratification: Initial risk screening is conducted using the validated SARC-F questionnaire. Isometric handgrip strength is assessed using a calibrated hydraulic hand dynamometer in accordance with American Society of Hand Therapists (ASHT) positioning. Dynamic lower-extremity physical performance is evaluated using the five-repetition chair stand test and the 4-meter usual gait speed test. Diagnostic categorization (probable, confirmed, and severe sarcopenia) is established based on the ISarcoPRM algorithm, supplemented by EWGSOP2 reference frameworks.

Ultrasonographic Muscle Architecture Assessment: High-resolution B-mode ultrasonography (Clarius L7 HD3 linear transducer) is utilized to evaluate muscle quantity and structural atrophy. Anterior thigh muscle thickness (rectus femoris and vastus intermedius) is measured at the midpoint between the anterior superior iliac spine (ASIS) and the superior patellar border to calculate the Sonographic Thigh Adjustment Ratio (STAR), normalizing muscle thickness to BMI. Lumbar multifidus muscle thickness is similarly quantified bilaterally at the L4-L5 intervertebral space in the prone position. All acoustic measurements employ abundant transmission gel to prevent soft-tissue compression artifacts.

In Vivo Passive Myotonometric Biomechanics: Non-invasive mechanical oscillation assessments are performed using a digital myotonometer (MyotonPRO) to record muscle tone (oscillation frequency, Hz), biomechanical stiffness (dynamic stiffness, N/m), and elasticity (logarithmic decrement). Standardized anatomical sites are tested bilaterally in a relaxed state:

Rectus Femoris: Midpoint between the ASIS and the superior patellar border (supine).

Tibialis Anterior: 12 cm distal to the lateral femoral condyle (supine).

Medial Gastrocnemius: 30 cm proximal to the posterior medial malleolus (prone).

Lumbar Extensors: 2 cm lateral to the L3-L4 intervertebral space (prone). Measurements are acquired in multi-scan mode applying consecutive mechanical impulses, and bilateral average parameters are computed for comparative biomechanical analysis.

Medical subject headings
Sarcopenia, Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07866807
Study groupRoleWhat they receive
Fusion Surgery GroupPatients who underwent multilevel lumbar fusion surgery at least 3 months ago
Control GroupThe group with chronic low back pain due to lumbar spinal stenosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of sarcopenia using the SARC-F test

    The SARC-F is a validated self-report screening tool comprising five components: strength (lifting and carrying 10 pounds), assistance in walking across a room, rising from a chair, climbing a flight of 10 stairs, and frequency of falls in the past year. Each item is scored from 0 to 2 points, yielding a total score ranging from 0 to 10. A cutoff score of ≥4 was considered indicative of sarcopenia risk and predictive of impaired muscle function, prompting subsequent quantitative muscle strength and ultrasound assessments.

    Measured: 02.02.2026-01.09.2026

  2. Hand dynamometer for muscle strength performance

    A Baseline® hydraulic hand dynamometer (90 kg capacity) was used to assess muscle strength in accordance with ISarcoPRM diagnostic criteria. According to the test procedure, three measurements of handgrip strength must be taken-with one-minute intervals between each-and the average value recorded. The measurement results are expressed in kilograms. ISarcoPRM recommends cut-off values of 32 kg for men and 19 kg for women regarding grip strength.

    Measured: 02.02.2026-01.09.2026

  3. The chair stand test

    The chair stand test is a fundamental tool used to evaluate lower-extremity function and muscle strength in older adults and various patient populations. In this test, participants begin by sitting on a chair without armrests, with their arms crossed over their chests and their hip and knee joints flexed at 90°. Assessment commences after participants receive the "ready" and "start" commands. The researcher records the time required to complete five sit-to-stand cycles. The chair stand test is performed twice with a 1-2 minute rest interval, and the fastest time is used for evaluation. ISarcoPRM recommends a cutoff value of ≥12 seconds for the chair stand test .

    Measured: 02.02.2026-01.09.2026

  4. Calculating the Sonographic Thigh Adjustment Ratio (STAR).

    Ultrasonographic evaluations will be performed using a high-resolution portable ultrasound system (Clarius L7 HD3, Clarius Mobile Health, Vancouver, Canada) equipped with a 4-13 MHz linear transducer. Measurements were performed with participants in a supine position, with knees in full extension and quadriceps muscles completely relaxed. The probe was placed transversely at the midpoint of the longitudinal line connecting the anterior superior iliac spine (ASIS) and the superior border of the patella. A generous amount of acoustic coupling gel was used to ensure optimal acoustic contact without applying excessive mechanical pressure to the underlying tissues. Anterior thigh muscle thickness was measured (in millimeters) as the vertical distance from the superficial fascia of the *rectus femoris* to the femoral periosteum, encompassing both the *rectus femoris* and *vastus intermedius* muscles. The STAR value was calculated by dividing the anterior thigh muscle thickness (mm) by the b

    Measured: 02.02.2026-01.09.2026

  5. The Thickness of the Multifidus muscle

    The thickness of the multifidus muscle-one of the lumbar extensor muscles-was measured at the level of the L4-L5 intervertebral space. Measurements were taken three times at the L4-L5 spinal level while the participants were in the prone position, and the mean value was included in the analysis

    Measured: 02.02.2026-01.09.2026

  6. Muscle Myotonometer

    The mechanical properties of gait-related muscles-specifically the rectus femoris (RF), tibialis anterior (TA), and gastrocnemius medialis (GM)-were assessed using a handheld myotonometer (MyotonPRO, Myoton AS, Tallinn, Estonia). Additionally, the biomechanical properties of the lumbar extensor muscles were evaluated using this method. All assessments were performed in a quiet examination room maintained at a constant temperature (22-24°C) following a 15-minute rest period intended to ensure complete physical relaxation and the absence of active voluntary muscle contraction. Measurements were taken bilaterally and evaluated by calculating the mean. This device non-invasively characterizes the biomechanical and viscoelastic properties of muscles

    Measured: 02.02.2026-01.09.2026

Secondary outcomes (1)
  1. Body Mass Index (BMI)

    It is obtained by dividing the patient's weight (kg) by the square of their height (meters).

    Measured: 02.02.2026-01.09.2026

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2026
  2. Study start5 Jan 2026
  3. Primary completion1 Sep 2026
  4. Study completion1 Oct 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
51 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT07866807
Sponsor's protocol ID
E-70712088-050.04-303873
Status last verified
Oct 2026
First submitted
30 Sep 2026
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: patient privacy

Publications

  • Kara M, Kaymak B, Ata AM, Ozkal O, Kara O, Baki A, Sengul Aycicek G, Topuz S, Karahan S, Soylu AR, Cakir B, Halil M, Ozcakar L. STAR-Sonographic Thigh Adjustment Ratio: A Golden Formula for the Diagnosis of Sarcopenia. Am J Phys Med Rehabil. 2020 Oct;99(10):902-908. doi: 10.1097/PHM.0000000000001439.

    PubMed 32941253
  • Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.

    PubMed 30312372
  • Wang T, Jiang J, Li C, Xuan Q, Sun L, Xu G, Gu H, Gao H. Effects of internet-based cognitive behavioral therapy on kinesiophobia, exercise adherence, and back muscle function after lumbar fusion surgery. BMC Musculoskelet Disord. 2026 Mar 18;27(1):357. doi: 10.1186/s12891-026-09617-z.

    PubMed 41845320
  • Carreon LY, Glassman SD, Howard J. Fusion and nonsurgical treatment for symptomatic lumbar degenerative disease: a systematic review of Oswestry Disability Index and MOS Short Form-36 outcomes. Spine J. 2008 Sep-Oct;8(5):747-55. doi: 10.1016/j.spinee.2007.06.013. Epub 2007 Nov 26.

    PubMed 18037354

Questions about this trial

What is this clinical trial studying?

An observational study of Older Adults (60 - 85 Years Old) and Sarcopenia, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of sarcopenia using the SARC-F test (time frame: 02.02.2026-01.09.2026). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07866807, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in