Psoriatic ArthritisNCT06437392
Evaluation of Sarcopenia and Related Factors in Patients Diagnosed With Psoriatic Arthritis
An observational study of Psoriatic Arthritis, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The purpose of the study is identify the prevalence of sarcopenia and its associated factors in patients with psoriatic arthritis. Furthermore, we aimed to investigate the predictive contribution of USG in diagnosing sarcopenia by assessing the thickness of the rectus femoris, vastus intermedius, and quadriceps… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriatic Arthritis
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2023to 20 Aug 2024
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients between the ages of 18-65, who were diagnosed with psoriatic arthritis at least one year ago according to the CASPAR criteria, and healthy controls, who visited Ankara Bilkent City Hospital Physical Medicine and Rehabilitation Department, were included.
Who may be able to join
- Diagnosed with psoriatic arthritis according to CASPAR criteria at least 1 year ago
- Between 18 and 65 years old
- Normal cognitive functions
- Agrees to participate in the study
- No changes in medical treatment for psoriatic arthritis in the last 3 months
Who cannot join
- Those with neurological diseases
- Those with hip dysplasia
- Those with upper and lower extremity deformities
- Those with upper and lower extremity joint arthroplasty
- Those with arthritis and deformities in the hands
- Those with lumbar stabilization
Show all 9Show fewer
- Those with cognitive impairment preventing participation in the study
- Those with body weight beyond the device\'s measurement capacity
- Those who do not agree to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent City Hospital Physical Therapy an Rehabilitation Hospital
Ankara, Bilkent-Cankaya, 06800
Gonca Canan DOGAN TOSUN, Medical Dovtor, 05383760095, gcdogan92@gmail.com
About this study
The purpose of the study is identify the prevalence of sarcopenia and its associated factors in patients with psoriatic arthritis. Furthermore, we aimed to investigate the predictive contribution of USG in diagnosing sarcopenia by assessing the thickness of the rectus femoris, vastus intermedius, and quadriceps muscles in patients with psoriatic arthritis.
Read the detailed description
After being informed about study and potential risk, all patient and giving written informed consent will undergo screnneing determite eligibility for study entire. Participants who agree to take part in the study and sign the informed consent form will be divided into two groups: patients and healthy volunteers. The patients will undergo a rheumatological examination, and sarcopenia screening will be conducted for both groups. Additionally, the quadriceps muscle thickness of both groups will be measured.
- Conditions
- Psoriatic Arthritis
- Keywords
- rheumatic disease, sarcopenia, ultrasonography
- Medical subject headings
- Arthritis, Psoriatic, Rheumatic Diseases, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Psoriatic arthritis | Psoriatic arthritis patient | |
| Healthy volunteer | Healthy Volunteer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grip strength
muscle strength measurement:Hand grip strength is a parameter used to assess sarcopenia. Therefore, the hand grip strength of participants will be measured. A Jamar hydraulic hand dynamometer (FEI®, model 5030J1, USA) will be used for measuring muscle strength.For the hand grip strength measurement, participants will be seated with back support, with the shoulder in adduction, the elbow at 90 degrees flexion, the forearm and wrist in neutral and supported
Measured: 1 day
4 m gait speed test
Participants are instructed to walk at a normal pace on a flat 6-meter surface (including the first 1 meter for acceleration, 4 meters for the walking test area, and the last 1 meter for deceleration). Those who take longer than 5 seconds to complete the 4 meters (walking speed <0.8 m/s) are evaluated as having low physical performance.
Measured: 1 day
Quality of life in sarcopenia scale (SARQoL)
The SARQoL (Sarcopenia Quality of Life) questionnaire consists of 55 items and 22 questions, organized into seven different domains of quality of life: physical and mental health, locomotion, body composition, functionality, daily living activities, leisure activities, and fears.
Measured: 1 day
Tinetti balance and walking test
It is a test that assesses the participants' balance and walking. It includes 9 questions for balance and 7 questions for walking. Each response is scored between 0 and 2 points.
Measured: 1 day
Hospital Anxiety and Depression Scale
It is a scale developed to identify cases of anxiety disorders and depression in patients in non-psychiatric hospital clinics. Both contain seven intertwined items.
Measured: 1 day
PSAID12
This is a questionnaire that assesses the quality of life of patients diagnosed with psoriatic arthritis. It addresses pain, fatigue, skin problems, ability to perform work and/or leisure activities, functional capacity, discomfort, sleep disturbances, embarrassment from appearance, social participation, and depression.In this test, patients receive a score between 0 and 10.
Measured: 1 day
DAS 28
In the method where tenderness and swelling in 28 joints are recorded, known as the Disease Activity Score (DAS 28), global pain assessment score is used along with CRP (C-Reactive Protein) or ESR (Erythrocyte Sedimentation Rate) values. Scores of 2.6 or lower are considered remission, while scores between 2.6 and 3.2 indicate low disease activity, scores between 3.2 and 5.1 indicate moderate disease activity, and scores above 5.1 indicate high disease activity.
Measured: 1 day
BASDAI
The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score consists of six questions in the form of a visual analog scale (VAS) related to the five main symptoms of Ankylosing Spondylitis over the past week: fatigue, spinal pain, peripheral joint pain/swelling, localized tenderness, and morning stiffness. A final score between 0 and 10 is obtained. A BASDAI score of 4 or higher is considered indicative of active disease.
Measured: 1 day
DAPSA
The Disease Activity Index for Psoriatic Arthritis (DAPSA) score involves a joint examination of the patient. 68 joints are assessed for tenderness, and 66 joints for swelling. The numbers of tender and swollen joints are determined. The physician evaluates the patient's overall pain during examination and scores it out of 10. The patient's Visual Analog Scale (VAS) value is also recorded. The CRP value is noted.
The score is then calculated simply by summing up all these values (number of tender joints + number of swollen joints + physician's assessment of overall pain + VAS + CRP).
A score between 0 and 4 indicates remission, 5 to 14 indicates low disease activity, 15 to 27 indicates moderate disease activity, and a score greater than 28 indicates high disease activity.
Measured: 1 day
PASI
The Psoriasis Area Severity Index (PASI) evaluates both the severity and extent of psoriasis lesions on four body regions: the scalp, arms, trunk, and legs. It assesses the percentage of body surface area affected by lesions (A=area score; 1=<10%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89%, 6=90-100%) and the severity of erythema (E), induration (I), and desquamation (D), each scored from 0 to 4.
PASI scores range from 0 to 72, with higher scores indicating more severe disease.
Measured: 1 day
ultrasonography
All participants included in the study will undergo sonographic examination using the Logiq 9 (GE, USA) ultrasound device and a high-frequency 7-12 MHz linear probe available in our clinic. The distance between the bilateral spina iliaca anterior superior and the upper pole of the patella of the participants' dominant and non-dominant extremities will be measured, and the distal 1/3 will be marked. The measurement will be taken in a seated upright position. Care will be taken to avoid compression during the measurement. After ensuring there is no compression in the subcutaneous fat tissue and muscle, an axial image will be recorded. The thickness of the subcutaneous fat tissue, vastus intermedius, rectus femoris, and total quadriceps will be measured three times, and the average of these measurements will be recorded.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start20 Jun 2023
- Primary completion20 Aug 2024 (estimated)
- Study completion20 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gonca Canan Doğan Tosun, Ankara City Hospital Bilkent
- Investigators
- Gonca Canan Dogan Tosun, Medical Doctor, Principal investigator, Ankara City Hospital BilkentTuba Güler, Assoc Prof, Study director, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06437392
- Sponsor's protocol ID
- 10026356
- Status last verified
- May 2024
- First submitted
- 19 May 2024
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
PubMed 30312372
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sarcopenia and Related Factors in Patients Diagnosed With Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT06437392
- Acronym / sponsor ID
- 10026356
- Conditions
- Psoriatic Arthritis
- Keywords
- rheumatic disease, sarcopenia, ultrasonography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 20 Aug 2024 (estimated)
- Study completion
- 20 Aug 2024 (estimated)
- First posted
- 31 May 2024 (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.
The purpose of the study is identify the prevalence of sarcopenia and its associated factors in patients with psoriatic arthritis. Furthermore, we aimed to investigate the predictive contribution of USG in diagnosing sarcopenia by assessing the thickness of the rectus femoris, vastus intermedius, and quadriceps muscles in patients with psoriatic arthritis.
Detailed description
After being informed about study and potential risk, all patient and giving written informed consent will undergo screnneing determite eligibility for study entire. Participants who agree to take part in the study and sign the informed consent form will be divided into two groups: patients and healthy volunteers. The patients will undergo a rheumatological examination, and sarcopenia screening will be conducted for both groups. Additionally, the quadriceps muscle thickness of both groups will be measured.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psoriatic arthritis | – | –Psoriatic arthritis patient |
| Healthy volunteer | – | –Healthy Volunteer |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients between the ages of 18-65, who were diagnosed with psoriatic arthritis at least one year ago according to the CASPAR criteria, and healthy controls, who visited Ankara Bilkent City Hospital Physical Medicine and Rehabilitation Department, were included.
Key inclusion criteria (5 listed)
- Diagnosed with psoriatic arthritis according to CASPAR criteria at least 1 year ago
- Between 18 and 65 years old
- Normal cognitive functions
- Agrees to participate in the study
- No changes in medical treatment for psoriatic arthritis in the last 3 months
Key exclusion criteria (9 listed)
- Those with neurological diseases
- Those with hip dysplasia
- Those with upper and lower extremity deformities
- Those with upper and lower extremity joint arthroplasty
- Those with arthritis and deformities in the hands
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Grip strength
Time frame: 1 day
muscle strength measurement:Hand grip strength is a parameter used to assess sarcopenia. Therefore, the hand grip strength of participants will be measured. A Jamar hydraulic hand dynamometer (FEI®, model 5030J1, USA) will be used for measuring muscle strength.For the hand grip strength measurement, participants will be seated with back support, with the shoulder in adduction, the elbow at 90 degrees flexion, the forearm and wrist in neutral and supported
4 m gait speed test
Time frame: 1 day
Participants are instructed to walk at a normal pace on a flat 6-meter surface (including the first 1 meter for acceleration, 4 meters for the walking test area, and the last 1 meter for deceleration). Those who take longer than 5 seconds to complete the 4 meters (walking speed <0.8 m/s) are evaluated as having low physical performance.
Quality of life in sarcopenia scale (SARQoL)
Time frame: 1 day
The SARQoL (Sarcopenia Quality of Life) questionnaire consists of 55 items and 22 questions, organized into seven different domains of quality of life: physical and mental health, locomotion, body composition, functionality, daily living activities, leisure activities, and fears.
Tinetti balance and walking test
Time frame: 1 day
It is a test that assesses the participants' balance and walking. It includes 9 questions for balance and 7 questions for walking. Each response is scored between 0 and 2 points.
Hospital Anxiety and Depression Scale
Time frame: 1 day
It is a scale developed to identify cases of anxiety disorders and depression in patients in non-psychiatric hospital clinics. Both contain seven intertwined items.
PSAID12
Time frame: 1 day
This is a questionnaire that assesses the quality of life of patients diagnosed with psoriatic arthritis. It addresses pain, fatigue, skin problems, ability to perform work and/or leisure activities, functional capacity, discomfort, sleep disturbances, embarrassment from appearance, social participation, and depression.In this test, patients receive a score between 0 and 10.
DAS 28
Time frame: 1 day
In the method where tenderness and swelling in 28 joints are recorded, known as the Disease Activity Score (DAS 28), global pain assessment score is used along with CRP (C-Reactive Protein) or ESR (Erythrocyte Sedimentation Rate) values. Scores of 2.6 or lower are considered remission, while scores between 2.6 and 3.2 indicate low disease activity, scores between 3.2 and 5.1 indicate moderate disease activity, and scores above 5.1 indicate high disease activity.
BASDAI
Time frame: 1 day
The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score consists of six questions in the form of a visual analog scale (VAS) related to the five main symptoms of Ankylosing Spondylitis over the past week: fatigue, spinal pain, peripheral joint pain/swelling, localized tenderness, and morning stiffness. A final score between 0 and 10 is obtained. A BASDAI score of 4 or higher is considered indicative of active disease.
DAPSA
Time frame: 1 day
The Disease Activity Index for Psoriatic Arthritis (DAPSA) score involves a joint examination of the patient. 68 joints are assessed for tenderness, and 66 joints for swelling. The numbers of tender and swollen joints are determined. The physician evaluates the patient's overall pain during examination and scores it out of 10. The patient's Visual Analog Scale (VAS) value is also recorded. The CRP value is noted. The score is then calculated simply by summing up all these values (number of tender joints + number of swollen joints + physician's assessment of overall pain + VAS + CRP). A score between 0 and 4 indicates remission, 5 to 14 indicates low disease activity, 15 to 27 indicates moderate disease activity, and a score greater than 28 indicates high disease activity.
PASI
Time frame: 1 day
The Psoriasis Area Severity Index (PASI) evaluates both the severity and extent of psoriasis lesions on four body regions: the scalp, arms, trunk, and legs. It assesses the percentage of body surface area affected by lesions (A=area score; 1=<10%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89%, 6=90-100%) and the severity of erythema (E), induration (I), and desquamation (D), each scored from 0 to 4. PASI scores range from 0 to 72, with higher scores indicating more severe disease.
ultrasonography
Time frame: 1 day
All participants included in the study will undergo sonographic examination using the Logiq 9 (GE, USA) ultrasound device and a high-frequency 7-12 MHz linear probe available in our clinic. The distance between the bilateral spina iliaca anterior superior and the upper pole of the patella of the participants' dominant and non-dominant extremities will be measured, and the distal 1/3 will be marked. The measurement will be taken in a seated upright position. Care will be taken to avoid compression during the measurement. After ensuring there is no compression in the subcutaneous fat tissue and muscle, an axial image will be recorded. The thickness of the subcutaneous fat tissue, vastus intermedius, rectus femoris, and total quadriceps will be measured three times, and the average of these measurements will be recorded.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Results publication: PubMed 30312372Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
- Individual participant dataSharing planned: No
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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.
Gonca Canan Dogan Tosun, Medical Doctor principal investigator
Ankara City Hospital Bilkent
Tuba Güler, Assoc Prof study director
Ankara City Hospital Bilkent
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 Psoriatic Arthritis, run by Ankara City Hospital Bilkent 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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 31 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tuba Güler, Assoc Prof (+905052841036, tubakulu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grip strength (time frame: 1 day). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06437392, which also lists 1 linked publication.
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 31 May 2024.