Muscle Architecture in Ankylosing Spondylitis

March 18, 2024 updated by: Bezmialem Vakif University

Muscle Architecture in Ankylosing Spondylitis and Its Relationship With Clinical Parameters

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Fatih
      • Istanbul, Fatih, Turkey, 34093
        • Bezmialem Vakif University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients who applied to the Bezmialem Vakıf University, Physical Medicine and Rehabilitation Outpatient Clinic appropriate for eligibility criteria will be enrolled.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Ankylosing Spondylitis

Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI), Rivermead Mobility Index (RMI) will be evaluated.

Vastus Lateralis, Tibialis Anterior, Lateral Gastrocnemius and Medial Gastrocnemius ultrasonography will be performed to evaluate muscle thickness, pennation angle and fascicle length.

Isometric knee extension, isometric ankle dorsiflexion and isometric ankle plantar flexion strength will be evaluated with hand held dynamometer.
Volunteers

Voluntary participants will be admitted to this group. Vastus Lateralis, Tibialis Anterior, Lateral Gastrocnemius and Medial Gastrocnemius ultrasonography will be performed to evaluate muscle thickness, pennation angle and fascicle length.

Isometric knee extension, isometric ankle dorsiflexion and isometric ankle plantar flexion strength will be evaluated with hand held dynamometer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rivermead Mobility Index
Time Frame: 1 Day
It 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.
1 Day
Isometric Knee Extension Muscle Strength
Time Frame: 1 Day
Isometric Knee Extension Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.
1 Day
Isometric Ankle Dorsiflexion Muscle Strength
Time Frame: 1 Day
Isometric Ankle Dorsiflexion Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.
1 Day
Isometric Ankle Plantar Flexion Muscle Strength
Time Frame: 1 Day
Isometric Ankle Plantar Flexion Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.
1 Day
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time Frame: 1 Day

It 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
1 Day
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time Frame: 1 Day
It 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.
1 Day
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Time Frame: 1 Day
BASMI 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.
1 Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Investigators

  • Study Director: Mehmet Serkan Kılıçoğlu, Ass.Prof., Bezmialem Vakif University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2024

Primary Completion (Actual)

February 1, 2024

Study Completion (Actual)

March 2, 2024

Study Registration Dates

First Submitted

January 18, 2024

First Submitted That Met QC Criteria

January 18, 2024

First Posted (Actual)

January 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/340

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rheumatic Diseases

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe