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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Turkey
      • Istanbul, Turkey
        • Bezmialem 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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:

  1. Having a diagnosis of ankylosing spondylitis according to Modified NewYork criteria
  2. Being male
  3. Aged ≥18

Exclusion Criteria:

  1. Severe cardiac or pulmonary or renal disease
  2. Accompanying fibromyalgia
  3. Severe psychiatric disorder
  4. Other disease limiting spinal, shoulder or hip range of motion
  5. Myopathy, neuropathy or radiculopathy that may cause muscle weakness
  6. Using high dose steroids
  7. Endocrinological disorders
  8. Malignancy
  9. 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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Ankylosing Spondylitis
Patients with ankylosing spondylitis meeting the inclusion and exclusion criteria
Other: Truncal flexion-extension muscle power
Patient performs a maximum truncal flexion laying supine on the bed with cap of muscle tester placed on sternum,
Other: Truncal extension muscle power
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.
Other: Cervical flexion muscle power
Patient performs a maximum cervical flexion sitting while the cap of manual muscle tester placed on the middle of the forehead.
Other: Cervical extension muscle power
Patient performs a maximum cervical extension sitting while the cap of manual muscle tester placed on protuberantia occipitalis.
Other: Cervical lateral flexion muscle powers
Patient performs a maximum cervical lateral flexions on right and left sitting while the cap of manual muscle tester placed on relevant pterion.
Other: Shoulder flexion muscle power
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.
Other: Shoulder extension muscle power
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.
Other: Shoulder internal rotation muscle power
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.
Other: Shoulder external rotation muscle power
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.
Other: Shoulder abduction muscle power
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.
Other: Hip flexion muscle power
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.
Other: Hip extension muscle power
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.
Other: Hip abduction muscle power
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.
Other: Hip internal rotation muscle power
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.
Other: Hip external rotation muscle power
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.
Other: Bath Ankylosing Spondylitis Functional Index (BASFI)
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.
Other: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
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.
Other: The Health assessment questionnaire (HAQ)
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.
Other: Bath Ankylosing Spondylitis Metrology Index (BASMI)
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
Healthy Controls
Healthy individuals meeting the exclusion criteria
Other: Truncal flexion-extension muscle power
Patient performs a maximum truncal flexion laying supine on the bed with cap of muscle tester placed on sternum,
Other: Truncal extension muscle power
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.
Other: Cervical flexion muscle power
Patient performs a maximum cervical flexion sitting while the cap of manual muscle tester placed on the middle of the forehead.
Other: Cervical extension muscle power
Patient performs a maximum cervical extension sitting while the cap of manual muscle tester placed on protuberantia occipitalis.
Other: Cervical lateral flexion muscle powers
Patient performs a maximum cervical lateral flexions on right and left sitting while the cap of manual muscle tester placed on relevant pterion.
Other: Shoulder flexion muscle power
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.
Other: Shoulder extension muscle power
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.
Other: Shoulder internal rotation muscle power
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.
Other: Shoulder external rotation muscle power
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.
Other: Shoulder abduction muscle power
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.
Other: Hip flexion muscle power
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.
Other: Hip extension muscle power
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.
Other: Hip abduction muscle power
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.
Other: Hip internal rotation muscle power
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.
Other: Hip external rotation muscle power
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cervical muscle powers
Time Frame: 1 day
Cervical flexion, extension, and lateral flexion muscle powers in kilograms as assessed with handheld dynamometer.
1 day
Truncal muscle powers
Time Frame: 1 day
Truncal flexion and extension muscle powers in kilograms as assessed with handheld dynamometer.
1 day
Shoulder girdle muscle powers
Time Frame: 1 day
Shoulder flexion, extension, abduction, internal rotation, and external rotation muscle powers in kilograms as assessed with handheld dynamometer.
1 day
Hip girdle muscle powers
Time Frame: 1 day
Hip flexion, extension, abduction, internal rotation, and external rotation muscle powers in kilograms as assessed with handheld dynamometer.
1 day

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bezmialem Vakif University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 18, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 4, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 4, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 9, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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