NCT06437392

Brief 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 muscles in patients with psoriatic arthritis.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 31, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2024

Completed
Last Updated

May 31, 2024

Status Verified

May 1, 2024

Enrollment Period

1.2 years

First QC Date

May 19, 2024

Last Update Submit

May 26, 2024

Conditions

Keywords

rheumatic diseasesarcopeniaultrasonography

Outcome Measures

Primary Outcomes (11)

  • 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

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    1 day

Study Arms (2)

Psoriatic arthritis

Psoriatic arthritis patient

Healthy volunteer

Healthy Volunteer

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Those with cognitive impairment preventing participation in the study
  • Those with body weight beyond the device\&#39;s measurement capacity
  • Those who do not agree to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital Physical Therapy an Rehabilitation Hospital

Ankara, Bilkent-Cankaya, 06800, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Arthritis, PsoriaticRheumatic DiseasesSarcopenia

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesConnective Tissue DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Gonca Canan Dogan Tosun, Medical Doctor

    Ankara City Hospital Bilkent

    PRINCIPAL INVESTIGATOR
  • Tuba Güler, Assoc Prof

    Ankara City Hospital Bilkent

    STUDY DIRECTOR

Central Study Contacts

Tuba Güler, Assoc Prof

CONTACT

Gonca Canan Dogan Tosun, Medical Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor (Physical Medicine and Rehabilitation)

Study Record Dates

First Submitted

May 19, 2024

First Posted

May 31, 2024

Study Start

June 20, 2023

Primary Completion

August 20, 2024

Study Completion

August 20, 2024

Last Updated

May 31, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations