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Muscle Architecture in Ankylosing Spondylitis

Muscle Architecture in Ankylosing Spondylitis and Its Relationship With Clinical Parameters

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06226792
Enrollment
30
Registered
2024-01-26
Start date
2024-01-18
Completion date
2024-03-02
Last updated
2024-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing Spondylitis, Muscle Weakness, Rheumatic Diseases

Brief summary

The goal of this observational study is to determine whether there is a decrease in muscle mass and the relationship between lower extremity skeletal muscle mass, muscle strength and disease activity in Ankylosing spondylitis. The main questions it aims to answer are: * Is there a relationship between the muscle thickness and pennation angle of the quadriceps, Gastrocnemius medialis and lateralis, Vastus medialis and lateralis and tibialis anterior muscles with disease activity and muscle strength? * Are there any differences in the results of morphological parameters of lower extremity muscles between Ankylosing spondylitis and voluntary participants? Researchers will compare voluntary participants to see if any difference in lower muscle morphological parameters.

Detailed description

Ankylosing spondylitis (AS) Ankylosing spondylitis (AS) is a systemic inflammatory rheumatic disease that can cause characteristic inflammatory low back pain and structural and functional disorders by affecting the axial and peripheral skeleton. Functional impairment increases with age, disease duration, and severity of symptoms. It has been shown that there is a significant relationship between dysfunction and activity limitation in AS patients. Recent studies have reported that both sarcopenia and decreased muscle strength occur in patients with chronic inflammatory diseases such as rheumatoid arthritis3. There are concerns that sarcopenia may affect exercise tolerance, activities of daily living, and ultimately have a negative impact on cardiovascular fitness and physical and emotional well-being. Given the risk of chronic inflammation and reduced physical activity, patients are also at risk of accelerated muscle wasting. In chronic diseases, loss of muscle mass, often referred to as cachexia, is a relevant systemic complication that leads to decreased muscle strength and endurance, reduced physical activity and fitness. However, there is no study reporting variation in lower extremity information, muscle development, morphological effects measured by ultrasound, muscle strength and disease intensity in AS patients. Therefore, this study was conducted to determine whether there is a decrease in muscle according to the wide general spread in AS patients and to strengthen the detachable lower extremity structure with AS, muscle strength and possible presence. The relationship between strength, power and mobility of skeletal muscles was also evaluated. Although muscle loss was not morphologically evident in previous ultrasounds, it has not been investigated whether this leads to loss of muscle strength.

Interventions

None listed

Sponsors

Bezmialem Vakif University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum

Inclusion criteria

* Being ≥18 years old, * Being diagnosed with AS according to The Assesment of Spondyloarthritis international society (ASAS) criteria * Ability to giving consent * Ability to live independently * Ability to walk without assistive devices.

Exclusion criteria

* History of surgery on the spine or lower extremities, * History of inflammatory rheumatic disease, * Severe cardiovascular disease, * Neuromuscular disease affecting muscle strength, * Individuals following a regular exercise program, * Secondary osteoarthritis.

Design outcomes

Primary

MeasureTime frameDescription
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)1 DayIt evaluates disease-specific symptoms such as fatigue, spinal and peripheral joint pain, swelling and morning stiffness and is interpreted on a score ranging from 0 to 10. Each question is scored on a scale of 0 to 10. Aside from the last question, 0 indicates none and 10 indicate very severe. For the last question, 0 is 0 hours, 5 is one hour, and 10 is two or more hours. To calculate the BASDAI score, the formula is: BASDAI = ((Q1 + Q2 + Q3 + Q4) + ((Q5 + Q6) / 2)) / 5
Bath Ankylosing Spondylitis Functional Index (BASFI)1 DayIt is an index that is fast and easy to apply, sensitive to changes and reliable, developed for determining and monitoring the functional status of patients with AS. It consists of 10 questions that evaluate patients' abilities to bend, reach, stand, change positions, climb stairs, and cope with activities of daily living. For each question, the final score is obtained by dividing the total score by 10 using the visual analogue scale (VAS) in the range of 0-10 cm. A higher score indicates a higher degree of functional limitations.
Bath Ankylosing Spondylitis Metrology Index (BASMI)1 DayBASMI consists of five clinical measurements: cervical rotation, tragus wall distance, lumbar flexion, trunk lateral flexion, and intermalleolar distance. It was first developed as a two-point scale in 1994 and was later adapted to a 10-point score. The 10-point BASMI scale was used in our study.The higher the BASMI score the more severe the patient's limitation of movement due to their Ankylosing Spondylitis.
Rivermead Mobility Index1 DayIt is a one-dimensional index that focuses on measuring mobility status and includes basic mobility activities. It includes a series of hierarchical activities, from turning over in bed to running, consisting of 14 questions and one observation that fit the Guttman Scale. RMI was mainly developed for the purpose of evaluating the results of physiotherapy interventions after head trauma or stroke, and it is reported that it can be used in hospitals, outpatient clinics or home environments without requiring expertise. Self-reporting is essential in answering questions. Only the 5th item is observed and evaluated by the interviewer. 1 point is given for each yes answer and a range of 0-15 points can be received. A score of 15 points indicates that there is no problem in mobility, and a score of 14 points and below indicates that there is a mobility problem.
Isometric Knee Extension Muscle Strength1 DayIsometric Knee Extension Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.
Isometric Ankle Dorsiflexion Muscle Strength1 DayIsometric Ankle Dorsiflexion Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.
Isometric Ankle Plantar Flexion Muscle Strength1 DayIsometric Ankle Plantar Flexion Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026