Rheumatoid ArthritisNCT06197074
Effect of Quadriceps Muscle on Physical Outcome Measures in Women With Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Ultrasound assessment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Dec 2023to 25 Dec 2025
- 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 60 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 18-60 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Afyonkarahisar Health Sciences University
Afyonkarahisar, 03030
ERDAL HORATA, PhD, +905056092631, erdalhorata@gmail.com
ERDAL HORATA, PhD
About this study
Official title: Evaluation of Morphologic Parameters of Quadriceps Muscle Predicting Disease Activity, Physical Performance and Quality of Life in Women With Rheumatoid Arthritis
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.
Read the detailed description
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.
Within the scope of the study, the morphological characteristics of the quadriceps muscle of the participants will be evaluated by a Physical Medicine and Rehabilitation specialist physician via ultrasound. After appropriate visualization, the image will be captured and saved in JPEG format, and will be exported to the ImageJ program for further analysis and evaluations will be performed by an anatomist. Assessments of quality of life and physical performance will be made by a physiotherapist involved in the study.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Ultrasound assessment
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound assessmentOther
The morphological characteristics of the quadriceps muscle of the participants will be assessed using ultrasound.
What is being measured
The primary outcome is the main question the study is designed to answer.
Vastus lateralis muscle length
Vastus Lateralis muscle length will be measured bilaterally by Ultrasound.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start25 Dec 2023
- Primary completion25 Dec 2025 (estimated)
- Study completion25 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erdal Horata, Afyonkarahisar Health Sciences University
- Investigators
- ERDAL HORATA, PhD, Principal investigator, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06197074
- Sponsor's protocol ID
- 2023/8
- Status last verified
- Jan 2024
- First submitted
- 26 Dec 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Morphologic Parameters of Quadriceps Muscle Predicting Disease Activity, Physical Performance and Quality of Life in Women With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT06197074
- Acronym / sponsor ID
- 2023/8
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 25 Dec 2023 (actual)
- Primary completion
- 25 Dec 2025 (estimated)
- Study completion
- 25 Dec 2025 (estimated)
- First posted
- 9 Jan 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.
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.
Detailed description
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.
Within the scope of the study, the morphological characteristics of the quadriceps muscle of the participants will be evaluated by a Physical Medicine and Rehabilitation specialist physician via ultrasound. After appropriate visualization, the image will be captured and saved in JPEG format, and will be exported to the ImageJ program for further analysis and evaluations will be performed by an anatomist. Assessments of quality of life and physical performance will be made by a physiotherapist involved in the study.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 18-60 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Ultrasound assessmentThe morphological characteristics of the quadriceps muscle of the participants will be assessed using ultrasound. | Other | – |
Primary outcome
Vastus lateralis muscle length
Time frame: 10 minutes
Vastus Lateralis muscle length will be measured bilaterally by Ultrasound.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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.
ERDAL HORATA, PhD principal investigator
Afyonkarahisar Health Sciences 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 Rheumatoid Arthritis, run by Afyonkarahisar Health Sciences 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 3 inclusion and 4 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 23 Jan 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 ERDAL HORATA, PhD (+905056092631, erdalhorata@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vastus lateralis muscle length (time frame: 10 minutes). 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 23 Jan 2024; AzTrials last refreshed its copy on 8 Nov 2026.