- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04435860
Muscle Strength Evaluations in Ankylosing Spondylitis
September 7, 2020 updated by: Bezmialem Vakif University
Evaluation of Relationship Between Trunk, Proximal Girdle Muscles' Strength, and Functionality and Disease Activity in Male Patients With Ankylosing Spondylitis
This study evaluates how the trunk and proximal girdle muscles are affected in male patients with ankylosing spondylitis, compared to healthy controls.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- Other: Truncal flexion-extension muscle power
- Other: Truncal extension muscle power
- Other: Cervical flexion muscle power
- Other: Cervical extension muscle power
- Other: Cervical lateral flexion muscle powers
- Other: Shoulder flexion muscle power
- Other: Shoulder extension muscle power
- Other: Shoulder internal rotation muscle power
- Other: Shoulder external rotation muscle power
- Other: Shoulder abduction muscle power
- Other: Hip flexion muscle power
- Other: Hip extension muscle power
- Other: Hip abduction muscle power
- Other: Hip internal rotation muscle power
- Other: Hip external rotation muscle power
- Other: Bath Ankylosing Spondylitis Functional Index (BASFI)
- Other: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
- Other: The Health assessment questionnaire (HAQ)
- Other: Bath Ankylosing Spondylitis Metrology Index (BASMI)
Detailed Description
Ankylosing spondylitis is a chronic, inflammatory rheumatic disease with an unclear etiology which causes back pain and affects the functionality of axial skeleton.
Besides the effect upon axial skeleton, the disease also affects the peripheral joints.
In most patients, tenuous affection of peripheral joints occurs however, in some others the disease causes impaired spinal mobility and articular instability.
This causes proximal girdle muscles and trunk muscles of the patients to be exposed to excessively stress and in conclusion deformities develop.
Maximum force generated by a muscle or muscle group directly effects the physical ability of an individual, and manual muscle dynamometers are used to directly evaluate the muscle strength.
In this manner the investigators aim to evaluate trunk and proximal girdle muscles' powers in male patients with ankylosing spondylitis and analyze the correlation between muscle powers, and functionality and disease activity.
Study Type
Observational
Enrollment (Actual)
100
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
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Istanbul, Turkey
- Bezmialem University
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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
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Controls: Healthy volunteers meeting inclusion criteria accepting to participate Ankylosing spondylitis group: Ankylosing spondylitis patients meeting inclusion criteria accepting to participate
Description
Inclusion Criteria:
- Having a diagnosis of ankylosing spondylitis according to Modified NewYork criteria
- Being male
- Aged ≥18
Exclusion Criteria:
- Severe cardiac or pulmonary or renal disease
- Accompanying fibromyalgia
- Severe psychiatric disorder
- Other disease limiting spinal, shoulder or hip range of motion
- Myopathy, neuropathy or radiculopathy that may cause muscle weakness
- Using high dose steroids
- Endocrinological disorders
- Malignancy
- Pregnancy
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
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Ankylosing Spondylitis
Patients with ankylosing spondylitis meeting the inclusion and exclusion criteria
|
Patient performs a maximum truncal flexion laying supine on the bed with cap of muscle tester placed on sternum,
Patient performs a maximum truncal extension laying prone on the bed while the cap of manual muscle tester placed on vertebrae at the level of midline between superior angles of scapulae.
Patient performs a maximum cervical flexion sitting while the cap of manual muscle tester placed on the middle of the forehead.
Patient performs a maximum cervical extension sitting while the cap of manual muscle tester placed on protuberantia occipitalis.
Patient performs a maximum cervical lateral flexions on right and left sitting while the cap of manual muscle tester placed on relevant pterion.
Patient performs a maximum shoulder flexion of the dominant side on upright while the cap of manual muscle tester placed on midpoint of the line between anterior aspect of acromion and anterior elbow.
Patient performs a maximum shoulder flexion of the dominant side on upright while the cap of manual muscle tester placed on midpoint of the line between posterior aspect of acromion and posterior elbow.
Patient performs a maximum shoulder internal rotation of the dominant side on upright while the cap of manual muscle tester placed on midpoint of the line between anterior elbow and wrist.
Patient performs a maximum shoulder external rotation of the dominant side on upright while the cap of manual muscle tester placed on midpoint of the line between posterior elbow and wrist.
Patient performs a maximum shoulder abduction of the dominant side on upright while the cap of manual muscle tester placed on midpoint of the line lateral aspect of acromion and lateral epicondyle.
Patient performs a maximum hip flexion laying supine on the bed while the cap of manual muscle tester placed on middle of the anterior thigh.
Patient performs a maximum hip extension laying prone on the bed while the cap of manual muscle tester placed on middle of the posterior thigh.
Patient performs a maximum hip abduction laying supine on the bed while the cap of manual muscle tester placed on middle of the lateral thigh.
Patient performs a maximum hip internal rotation laying supine on the bed while the cap of manual muscle tester placed on the midline between lateral condyle of femur and lateral malleolus.
Patient performs a maximum hip external rotation laying supine on the bed while the cap of manual muscle tester placed on the midline between medial condyle of femur and medial malleolus.
This questionnaire evaluates the functionality in patients with AS.
The ten questions that comprise the BASFI were chosen with input from patients with AS.
The first 8 questions evaluate activities related to functional anatomical limitations due to the course of this inflammatory disease.
The final 2 questions evaluate the patients' ability to cope with everyday life.
A visual analogue scale (with 0 being "easy" and 10 "impossible) is used to answer the questions on the test.
The final score varies between 0 and 10.
This questionnaire evaluates the disease activity level in patients with AS.
The BASDAI consists of a 0 - 10 scale measuring discomfort, pain, and fatigue (0 being no problem and 10 being the worst problem) in response to six questions asked of the patient pertaining to the five major symptoms of AS.
The final score varies between 0 and 10.
The Health assessment questionnaire (HAQ) is a questionnaire for the assessment of disability in an individual.
The patients report the amount of difficulty they have in performing eight daily living activities.
Each question asks on a scale ranging from 0 to 3 if the categories can be performed without any difficulty (scale 0) up to cannot be done at all (scale 3).
The final score varies between 0 and 3.
Bath Ankylosing Spondylitis Metrology Index, a combined index to assess the spinal mobility.
It evaluates the patients regarding cervical rotation, tragus-to-wall distance, lumbar flexion, lumbar lateral flexion and intermalleolar distance.
The total score varies between 5 to 15 in patients with ankylosing spondylitis
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Healthy Controls
Healthy individuals meeting the exclusion criteria
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Patient performs a maximum truncal flexion laying supine on the bed with cap of muscle tester placed on sternum,
Patient performs a maximum truncal extension laying prone on the bed while the cap of manual muscle tester placed on vertebrae at the level of midline between superior angles of scapulae.
Patient performs a maximum cervical flexion sitting while the cap of manual muscle tester placed on the middle of the forehead.
Patient performs a maximum cervical extension sitting while the cap of manual muscle tester placed on protuberantia occipitalis.
Patient performs a maximum cervical lateral flexions on right and left sitting while the cap of manual muscle tester placed on relevant pterion.
Patient performs a maximum shoulder flexion of the dominant side on upright while the cap of manual muscle tester placed on midpoint of the line between anterior aspect of acromion and anterior elbow.
Patient performs a maximum shoulder flexion of the dominant side on upright while the cap of manual muscle tester placed on midpoint of the line between posterior aspect of acromion and posterior elbow.
Patient performs a maximum shoulder internal rotation of the dominant side on upright while the cap of manual muscle tester placed on midpoint of the line between anterior elbow and wrist.
Patient performs a maximum shoulder external rotation of the dominant side on upright while the cap of manual muscle tester placed on midpoint of the line between posterior elbow and wrist.
Patient performs a maximum shoulder abduction of the dominant side on upright while the cap of manual muscle tester placed on midpoint of the line lateral aspect of acromion and lateral epicondyle.
Patient performs a maximum hip flexion laying supine on the bed while the cap of manual muscle tester placed on middle of the anterior thigh.
Patient performs a maximum hip extension laying prone on the bed while the cap of manual muscle tester placed on middle of the posterior thigh.
Patient performs a maximum hip abduction laying supine on the bed while the cap of manual muscle tester placed on middle of the lateral thigh.
Patient performs a maximum hip internal rotation laying supine on the bed while the cap of manual muscle tester placed on the midline between lateral condyle of femur and lateral malleolus.
Patient performs a maximum hip external rotation laying supine on the bed while the cap of manual muscle tester placed on the midline between medial condyle of femur and medial malleolus.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cervical muscle powers
Time Frame: 1 day
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Cervical flexion, extension, and lateral flexion muscle powers in kilograms as assessed with handheld dynamometer.
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1 day
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Truncal muscle powers
Time Frame: 1 day
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Truncal flexion and extension muscle powers in kilograms as assessed with handheld dynamometer.
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1 day
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Shoulder girdle muscle powers
Time Frame: 1 day
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Shoulder flexion, extension, abduction, internal rotation, and external rotation muscle powers in kilograms as assessed with handheld dynamometer.
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1 day
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Hip girdle muscle powers
Time Frame: 1 day
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Hip flexion, extension, abduction, internal rotation, and external rotation muscle powers in kilograms as assessed with handheld dynamometer.
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1 day
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ozan Volkan Yurdakul, Assoc Prof, Bezmialem 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
- Kim SC, Lee YG, Park SB, Kim TH, Lee KH. Muscle Mass, Strength, Mobility, Quality of Life, and Disease Severity in Ankylosing Spondylitis Patients: A Preliminary Study. Ann Rehabil Med. 2017 Dec;41(6):990-997. doi: 10.5535/arm.2017.41.6.990. Epub 2017 Dec 28.
- Daloia LMT, Leonardi-Figueiredo MM, Martinez EZ, Mattiello-Sverzut AC. Isometric muscle strength in children and adolescents using Handheld dynamometry: reliability and normative data for the Brazilian population. Braz J Phys Ther. 2018 Nov-Dec;22(6):474-483. doi: 10.1016/j.bjpt.2018.04.006. Epub 2018 May 4.
- De Blaiser C, De Ridder R, Willems T, Danneels L, Roosen P. Reliability and validity of trunk flexor and trunk extensor strength measurements using handheld dynamometry in a healthy athletic population. Phys Ther Sport. 2018 Nov;34:180-186. doi: 10.1016/j.ptsp.2018.10.005. Epub 2018 Oct 12.
- Yurdakul OV, Ince OE, Bagcier F, Kara M, Kultur E, Aydin T. Evaluating the strength of spinal and proximal girdle muscles in patients with axial spondyloarthritis: Correlation with activity, disability, and functionality. Int J Rheum Dis. 2021 May;24(5):701-710. doi: 10.1111/1756-185X.14102. Epub 2021 Mar 22.
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)
June 18, 2020
Primary Completion (Actual)
September 4, 2020
Study Completion (Actual)
September 4, 2020
Study Registration Dates
First Submitted
June 15, 2020
First Submitted That Met QC Criteria
June 16, 2020
First Posted (Actual)
June 17, 2020
Study Record Updates
Last Update Posted (Actual)
September 9, 2020
Last Update Submitted That Met QC Criteria
September 7, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-08/115
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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.
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