SarcopeniaNCT06121154
Pseudoexfoliation Syndrome, Sarcopenia and Chronic Pain
An observational study of Sarcopenia and Pseudoexfoliation Syndrome, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Pseudoexfoliation Syndrome
- What is being tested?
- SARC-F questionnaire, Gait speed and The chair rise test
- Type of treatment
- Pill or oral medicine
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Mar 2023to 25 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This case-control study was conducted with 98 patients who admitted to Department of Physical Medicine and Rehabilitation Outpatient Clinic, Eskişehir Osmangazi University Hospital between March-August 2023.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Possible Association Between Pseudoexfoliation Syndrome, Sarcopenia and Chronic Pain
Aim: Pseudoexfoliation syndrome (PEX) is a systemic disease of connective tissue, it can also contribute to sarcopenia and chronic musculoskeletal pain with common pathways.
- First aim of this study was to investigate whether the rate of sarcopenia is higher in patients with PEX
- 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).
Read the 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.
- First aim of this study was to investigate whether the rate of sarcopenia is higher in patients with PEX
- 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
- Sarcopenia, Pseudoexfoliation Syndrome
- Being tested
- SARC-F questionnaire, Gait speed, The chair rise test, Grip strength, Visual analog scale
- Keywords
- sarcopenia, pseudoexfoliation syndrome, chronic pain
- Medical subject headings
- Sarcopenia, Exfoliation Syndrome, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARC-F questionnaireDiagnostic test
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 speedDiagnostic test
Low gait speed was defined as walking below than 0.8 meters per second.
The chair rise testDiagnostic 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 strengthDiagnostic test
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 scaleDiagnostic test
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: SARC-F questionnaire; Diagnostic Test: Gait speed; Diagnostic Test: The chair rise test; Diagnostic Test: Grip strength; Diagnostic Test: Visual analog scale | |
| 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 Receives: Diagnostic Test: SARC-F questionnaire; Diagnostic Test: Gait speed; Diagnostic Test: The chair rise test; Diagnostic Test: Grip strength; Diagnostic Test: Visual analog scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARC-F
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.
Measured: Baseline
Secondary outcomes (4)
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
Measured: Baseline
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)
Measured: Baseline
The chair rise test
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
Measured: Baseline
Gait speed
Low gait speed was defined as walking below than 0.8 meters per second.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start30 Mar 2023
- Primary completion15 Aug 2023
- Study completion25 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur Armağan, Eskisehir Osmangazi University
- Investigators
- Fulya Bakılan, Assoc Prof, Study director, Eskişehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06121154
- Sponsor's protocol ID
- SarcoPEX
- Status last verified
- Nov 2023
- First submitted
- 2 Nov 2023
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Possible Association Between Pseudoexfoliation Syndrome, Sarcopenia and Chronic Pain
- ClinicalTrials.gov ID
- NCT06121154
- Acronym / sponsor ID
- SarcoPEX
- Conditions
- Sarcopenia, Pseudoexfoliation Syndrome
- Keywords
- sarcopenia, pseudoexfoliation syndrome, chronic pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 25 Oct 2023 (actual)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim: Pseudoexfoliation syndrome (PEX) is a systemic disease of connective tissue, it can also contribute to sarcopenia and chronic musculoskeletal pain with common pathways.
- First aim of this study was to investigate whether the rate of sarcopenia is higher in patients with PEX
- 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.
- First aim of this study was to investigate whether the rate of sarcopenia is higher in patients with PEX
- 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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEX-positive patients | – | Diagnostic Test: SARC-F questionnaire, Diagnostic Test: Gait speed, Diagnostic Test: The chair rise test, Diagnostic Test: Grip strength, Diagnostic Test: Visual analog scaleThe 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 | – | Diagnostic Test: SARC-F questionnaire, Diagnostic Test: Gait speed, Diagnostic Test: The chair rise test, Diagnostic Test: Grip strength, Diagnostic Test: Visual analog scaleThe 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This case-control study was conducted with 98 patients who admitted to Department of Physical Medicine and Rehabilitation Outpatient Clinic, Eskişehir Osmangazi University Hospital between March-August 2023.
Key inclusion criteria (2 listed)
- Being over 60 years
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SARC-F questionnaireThe 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. | Diagnostic test | PEX-negative patients, PEX-positive patients |
| Gait speedLow gait speed was defined as walking below than 0.8 meters per second. | Diagnostic test | PEX-negative patients, PEX-positive patients |
| The chair rise testthe 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 | Diagnostic test | PEX-negative patients, PEX-positive patients |
| Grip strengthGrip 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 | Diagnostic test | PEX-negative patients, PEX-positive patients |
| Visual analog scaleThe visual analogue scale (VAS) was used for measuring general body pain severity, which was assessed from 0 (no pain) to 10 (worst possible pain) | Diagnostic test | PEX-negative patients, PEX-positive patients |
Primary outcome
SARC-F
Time frame: 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.
4 secondary outcomes
Grip strength
Time frame: Baseline
Visual analog scale
Time frame: Baseline
The chair rise test
Time frame: Baseline
Gait speed
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Sarcopenia
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
MF-300 for Treatment of Age-Related Sarcopenia
Sarcopenia in Elderly
Not yet recruitingObservational study
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
Hypothyroidism, Psychometrics
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fulya Bakılan, Assoc Prof study director
Eskişehir Osmangazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Pseudoexfoliation Syndrome, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SARC-F (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.