Sarcopenia Clinical Trial
Official title:
A Possible Association Between Pseudoexfoliation Syndrome, Sarcopenia and Chronic Pain
NCT number | NCT06121154 |
Other study ID # | SarcoPEX |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 30, 2023 |
Est. completion date | October 25, 2023 |
Verified date | November 2023 |
Source | Eskisehir Osmangazi University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 96 |
Est. completion date | October 25, 2023 |
Est. primary completion date | August 15, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Eskisehir Osmangazi University | Eskisehir |
Lead Sponsor | Collaborator |
---|---|
Eskisehir Osmangazi University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline | |
Secondary | 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 | Baseline | |
Secondary | 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) | Baseline | |
Secondary | 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 | Baseline | |
Secondary | Gait speed | Low gait speed was defined as walking below than 0.8 meters per second. | Baseline |
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