NCT06197074

Brief Summary

Studies have reported that individuals with Rheumatoid Arthritis have a smaller muscle cross-sectional area, pennation angle and muscle thickness than healthy controls. Sarcopenia may decrease physical performance and quality of life in individuals with RA. Therefore, morphologic changes in the quadriceps femoris muscle due to sarcopenia may help us to gain insight into physical function and quality of life. This study aims to evaluate the predictive capacity of morphologic characteristics of the quadriceps femoris muscle for disease activity, physical performance, and quality of life in women with Rheumatoid Arthritis.

Trial Health

43
At Risk

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 Dec 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

December 25, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 26, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 9, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2025

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

2 years

First QC Date

December 26, 2023

Last Update Submit

January 20, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Vastus lateralis muscle length

    Vastus Lateralis muscle length will be measured bilaterally by Ultrasound.

    10 minutes

Interventions

The morphological characteristics of the quadriceps muscle of the participants will be assessed using ultrasound.

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Female participants between the ages of 18-65 who have been diagnosed with Rheumatoid Arthritis for at least 3 years and who come to Afyonkarahisar Health Sciences University Physical Therapy and Rehabilitation outpatient clinic will be included in the study.

You may qualify if:

  • years old
  • Female participants with a confirmed diagnosis of RA for at least 3 years according to the 2010 American College of Rheumatology (ACR) criteria
  • Presence of sarcopenia

You may not qualify if:

  • Presence of fractures, burns or lesions in the area to be measured
  • Presence of any neuromuscular, cardiovascular or metabolic disease,
  • Individuals with knee endoprosthesis,
  • Inability to walk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Afyonkarahisar Health Sciences University

Afyonkarahisar, 03030, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • ERDAL HORATA, PhD

    Afyonkarahisar Health Sciences University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ERDAL HORATA, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD; Lecturer; Principal Investigator

Study Record Dates

First Submitted

December 26, 2023

First Posted

January 9, 2024

Study Start

December 25, 2023

Primary Completion

December 25, 2025

Study Completion

December 25, 2025

Last Updated

January 23, 2024

Record last verified: 2024-01

Locations