Muscle Strength Evaluations in Ankylosing Spondylitis

NCT04435860 | Completed

• 1 other identifier: 2019-08/115
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates how the trunk and proximal girdle muscles are affected in male patients with ankylosing spondylitis, compared to healthy controls.

Conditions

Ankylosing Spondylitis

Keywords

Muscle Powers; Functionality; Disease Activity

Outcome Measures

Primary Outcomes (4)

• Cervical muscle powers

  Cervical flexion, extension, and lateral flexion muscle powers in kilograms as assessed with handheld dynamometer.

  1 day

• Truncal muscle powers

  Truncal flexion and extension muscle powers in kilograms as assessed with handheld dynamometer.

  1 day

• Shoulder girdle muscle powers

  Shoulder flexion, extension, abduction, internal rotation, and external rotation muscle powers in kilograms as assessed with handheld dynamometer.

  1 day

• Hip girdle muscle powers

  Hip flexion, extension, abduction, internal rotation, and external rotation muscle powers in kilograms as assessed with handheld dynamometer.

  1 day

Study Arms (2)

Ankylosing Spondylitis

Patients with ankylosing spondylitis meeting the inclusion and exclusion criteria

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)

Healthy Controls

Healthy individuals meeting the exclusion criteria

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

Interventions

Truncal flexion-extension muscle power OTHER

Patient performs a maximum truncal flexion laying supine on the bed with cap of muscle tester placed on sternum,

Ankylosing Spondylitis; Healthy Controls

Truncal extension muscle power OTHER

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.

Ankylosing Spondylitis; Healthy Controls

Cervical flexion muscle power OTHER

Patient performs a maximum cervical flexion sitting while the cap of manual muscle tester placed on the middle of the forehead.

Ankylosing Spondylitis; Healthy Controls

Cervical extension muscle power OTHER

Patient performs a maximum cervical extension sitting while the cap of manual muscle tester placed on protuberantia occipitalis.

Ankylosing Spondylitis; Healthy Controls

Cervical lateral flexion muscle powers OTHER

Patient performs a maximum cervical lateral flexions on right and left sitting while the cap of manual muscle tester placed on relevant pterion.

Ankylosing Spondylitis; Healthy Controls

Shoulder flexion muscle power OTHER

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.

Ankylosing Spondylitis; Healthy Controls

Shoulder extension muscle power OTHER

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.

Ankylosing Spondylitis; Healthy Controls

Shoulder internal rotation muscle power OTHER

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.

Ankylosing Spondylitis; Healthy Controls

Shoulder external rotation muscle power OTHER

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.

Ankylosing Spondylitis; Healthy Controls

Shoulder abduction muscle power OTHER

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.

Ankylosing Spondylitis; Healthy Controls

Hip flexion muscle power OTHER

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.

Ankylosing Spondylitis; Healthy Controls

Hip extension muscle power OTHER

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.

Ankylosing Spondylitis; Healthy Controls

Hip abduction muscle power OTHER

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.

Ankylosing Spondylitis; Healthy Controls

Hip internal rotation muscle power OTHER

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.

Ankylosing Spondylitis; Healthy Controls

Hip external rotation muscle power OTHER

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.

Ankylosing Spondylitis; Healthy Controls

Bath Ankylosing Spondylitis Functional Index (BASFI) OTHER

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.

Ankylosing Spondylitis

Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) OTHER

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.

Ankylosing Spondylitis

The Health assessment questionnaire (HAQ) OTHER

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.

Ankylosing Spondylitis

Bath Ankylosing Spondylitis Metrology Index (BASMI) OTHER

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

Ankylosing Spondylitis

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Having a diagnosis of ankylosing spondylitis according to Modified NewYork criteria
• Being male
• Aged ≥18

You may not qualify if:

• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem University

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 29354575 BACKGROUND

• 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.

  PMID: 29802034 BACKGROUND

• 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.

  PMID: 30366246 BACKGROUND

• 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.

  PMID: 33750032 DERIVED

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Officials

• Ozan Volkan Yurdakul, Assoc Prof

  Bezmialem University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 17, 2020
• Study Start: June 18, 2020
• Primary Completion: September 4, 2020
• Study Completion: September 4, 2020
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)