Pseudoexfoliation Syndrome, Sarcopenia and Chronic Pain

Completed

• Conditions: Sarcopenia; Pseudoexfoliation Syndrome
• Interventions: Diagnostic Test: SARC-F questionnaire; Diagnostic Test: Gait speed; Diagnostic Test: The chair rise test; Diagnostic Test: Grip strength; Diagnostic Test: Visual analog scale

• Registration Number: NCT06121154
• Lead Sponsor: Eskisehir Osmangazi University

Brief Summary

Aim: Pseudoexfoliation syndrome (PEX) is a systemic disease of connective tissue, it can also contribute to sarcopenia and chronic musculoskeletal pain with common pathways.

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).

Detailed Description

Sarcopenia is defined as a decreased muscle mass, muscle strength and muscle function, which leads to lower physical performance, disability and quality of life. Pseudoexfoliation syndrome (PEX) is an age-related, genetic and systemic disease characterized by the accumulation of abnormal extracellular fibrillar material in many ocular and extraocular tissues Aim: Pseudoexfoliation syndrome (PEX) is a systemic disease of connective tissue, it can also contribute to sarcopenia and chronic musculoskeletal pain with common pathways.

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).

Study Timeline

• Study Start: 2023-03-30
• Primary Completion: 2023-08-15
• Study Completion: 2023-10-25
• Status Verified: 2023-11
• Study First Submitted: 2023-11-02
• Study First Submitted QC: 2023-11-02
• Study First Posted: 2023-11-07
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• Being over 60 years

  • 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

• having ophtalmic diseases that cause vision loss and reduce quality of life and mobility smoking, acute/subacute pain, amputation, infection, active arthritis, active cancer, having any protesis or surgery in lower extremities and low back, neurological disorders, malabsorption, weight loss, uncontrolled major systemic diseases, impaired cognitive function and being immobilised.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PEX-negative patients	The chair rise test	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
PEX-positive patients	Gait speed	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
PEX-positive patients	The chair rise test	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
PEX-negative patients	SARC-F questionnaire	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
PEX-negative patients	Gait speed	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
PEX-negative patients	Grip strength	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
PEX-positive patients	SARC-F questionnaire	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
PEX-positive patients	Grip strength	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
PEX-positive patients	Visual analog scale	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
PEX-negative patients	Visual analog scale	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

Primary Outcome Measures

Name	Time	Method
SARC-F	Baseline	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.

Secondary Outcome Measures

Name	Time	Method
Gait speed	Baseline	Low gait speed was defined as walking below than 0.8 meters per second.
Grip strength	Baseline	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
The chair rise test	Baseline	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
Visual analog scale	Baseline	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)

Trial Locations

Locations (1)

Eskişehir Osmangazi University; 🇹🇷 Eskişehir, Turkey