Pseudoexfoliation Syndrome, Sarcopenia and Chronic Pain
NCT ID: NCT06121154
Last Updated: 2023-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
96 participants
OBSERVATIONAL
2023-03-30
2023-10-25
Brief Summary
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1. First aim of this study was to investigate whether the rate of sarcopenia is higher in patients with PEX
2. Second aim was to investigate the association between PEX, sarcopenia parameters and chronic musculoskeletal pain.
Methods: A total of 96-patients were enrolled in this study and divided into two groups: PEX-positive (n=48) and PEX-negative (n=48) patients. The variables: the demographic data, sarcopenia parameters (SARC-F-questionnaire, hand-grip strength, chair-rise test, gait speed) and pain parameters (having any chronic musculoskeletal pain, pain regions and visual analogue scale-pain).
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Detailed Description
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1. First aim of this study was to investigate whether the rate of sarcopenia is higher in patients with PEX
2. Second aim was to investigate the association between PEX, sarcopenia parameters and chronic musculoskeletal pain.
Methods: A total of 96-patients were enrolled in this study and divided into two groups according to having pseudoexfoliation material in ocular tissues: PEX-positive (n=48) and PEX-negative (n=48) patients. The variables: the demographic data, sarcopenia parameters (SARC-F-questionnaire, hand-grip strength, chair-rise test, gait speed) and pain parameters (having any chronic musculoskeletal pain, pain regions and visual analogue scale-pain).
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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PEX-positive patients
The criteria to diagnose Pseudoexfoliation syndrome (PEX) were, after pupillary dilatation, the presence of white fluffy dandruff-like material on one or more anterior segment structures, including the pupillary margin, the anterior lens capsule, or the angle in biomicroscopic examination. The patients were divided into two groups: solely based on PEX-positive (n=48) and PEX-negative (n=48) status
SARC-F questionnaire
The SARC-F scale has 5 questions which evaluate strength, assistance in ambulation, rising from a chair, stair climbing, and falls. The cut off point for predicting sarcopenia is score 4; "4 and more" means risk of sarcopenia.
Gait speed
Low gait speed was defined as walking below than 0.8 meters per second.
The chair rise test
the chair rise test (measures the strength of leg muscles), it measures the time taken for 5 times of rising from the sitting position without using arms, and was defined as low when the time taken was more than 15 seconds
Grip strength
Grip strength was measured with a hand-held dynamometer (Baseline, White Plains, New York, USA), and the cut-off thresholds were 32 kg for males and 22 kg for females
Visual analog scale
The visual analogue scale (VAS) was used for measuring general body pain severity, which was assessed from 0 (no pain) to 10 (worst possible pain)
PEX-negative patients
The criteria to diagnose Pseudoexfoliation syndrome (PEX) were, after pupillary dilatation, the presence of white fluffy dandruff-like material on one or more anterior segment structures, including the pupillary margin, the anterior lens capsule, or the angle in biomicroscopic examination. The patients were divided into two groups: solely based on PEX-positive (n=48) and PEX-negative (n=48) status
SARC-F questionnaire
The SARC-F scale has 5 questions which evaluate strength, assistance in ambulation, rising from a chair, stair climbing, and falls. The cut off point for predicting sarcopenia is score 4; "4 and more" means risk of sarcopenia.
Gait speed
Low gait speed was defined as walking below than 0.8 meters per second.
The chair rise test
the chair rise test (measures the strength of leg muscles), it measures the time taken for 5 times of rising from the sitting position without using arms, and was defined as low when the time taken was more than 15 seconds
Grip strength
Grip strength was measured with a hand-held dynamometer (Baseline, White Plains, New York, USA), and the cut-off thresholds were 32 kg for males and 22 kg for females
Visual analog scale
The visual analogue scale (VAS) was used for measuring general body pain severity, which was assessed from 0 (no pain) to 10 (worst possible pain)
Interventions
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SARC-F questionnaire
The SARC-F scale has 5 questions which evaluate strength, assistance in ambulation, rising from a chair, stair climbing, and falls. The cut off point for predicting sarcopenia is score 4; "4 and more" means risk of sarcopenia.
Gait speed
Low gait speed was defined as walking below than 0.8 meters per second.
The chair rise test
the chair rise test (measures the strength of leg muscles), it measures the time taken for 5 times of rising from the sitting position without using arms, and was defined as low when the time taken was more than 15 seconds
Grip strength
Grip strength was measured with a hand-held dynamometer (Baseline, White Plains, New York, USA), and the cut-off thresholds were 32 kg for males and 22 kg for females
Visual analog scale
The visual analogue scale (VAS) was used for measuring general body pain severity, which was assessed from 0 (no pain) to 10 (worst possible pain)
Eligibility Criteria
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Inclusion Criteria
* Undergoing a detailed complete ophtalmic examination by an experienced physician within 1 month at the Department of Ophtalmology in the same university hospital.
Exclusion Criteria
60 Years
ALL
Yes
Sponsors
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Eskisehir Osmangazi University
OTHER
Responsible Party
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Onur Armağan
Prof.
Principal Investigators
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Fulya Bakılan, Assoc Prof
Role: STUDY_DIRECTOR
Eskişehir Osmangazi University
Locations
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Eskişehir Osmangazi University
Eskişehir, , Turkey (Türkiye)
Countries
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Other Identifiers
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SarcoPEX
Identifier Type: -
Identifier Source: org_study_id
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