Sjogren SyndromeNCT06879444
"Core Stabilization Strenght and Pelvic Floor Functions in Primary Sjogren's"
An observational study of Sjogren Syndrome and Healthy Volunteers, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to explain the comparison of core stabilization strength and pelvic floor functions between individuals diagnosed with Sjogren syndrome and a healthy control group. (Sjogren syndrome group n=27; control group n=27) Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sjogren Syndrome, Healthy Volunteers
- What is being tested?
- Core Muscle testing and patient reported outcome measures
- How many people
- 10 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Feb 2025to 5 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Sjogren syndrome group and control group
Who may be able to join
- Sjogren syndrome group:
- Diagnosed by a rheumatologist
- Being 18 years of age or older,
- Agreeing to participate in the study
- Control group:
- -Being 18 years of age or older,
Who cannot join
- Sjogren syndrome group and control group:
- Presence of neurological disease
- Presence of any orthopedic problem that would affect functionality
- Presence of a history of orthopedic surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Pamukkale Üniversitesi
Denizli, Denizli, 20000
About this study
Official title: "Investigation of 'Core' Stabilization Strength and Pelvic Floor Functions in Individuals with Primary Sjogren: a Controlled Study"
This study aims to explain the comparison of core stabilization strength and pelvic floor functions between individuals diagnosed with Sjogren syndrome and a healthy control group.
(Sjogren syndrome group n=27; control group n=27)
- Conditions
- Sjogren Syndrome, Healthy Volunteers
- Being tested
- Core Muscle testing and patient reported outcome measures
- Keywords
- pelvic floor, core stabilization, Sjogren syndrome
- Medical subject headings
- Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core Muscle testing and patient reported outcome measuresOther
These are the situation evaluation parameters. It presents the data of the participants at the time of evaluation.
| Study group | Role | What they receive |
|---|---|---|
| control group | The control group will consist of healthy volunteers. Receives: Other: Core Muscle testing and patient reported outcome measures | |
| Sjogren syndrome | The Sjogren syndrome group will consist of patients aged between 18-65 who apply to the Rheumatology Department of Pamukkale University and meet the inclusion criteria. Receives: Other: Core Muscle testing and patient reported outcome measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic Floor Distress Inventory-20 (PTDE-20)
There are 20 questions in total on the scale. The best score that can be obtained from the entire survey is "0" and the worst score is "300".
Measured: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Sexual Life Quality Scale- Women (CYKÖ-K)
The maximum score that can be obtained from the scale with this system is 108.
Measured: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Incontinence Impact Questionnaire (IIQ-7) (IES)
Consists of 7 items. Maximum score is 100.
Measured: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
The McGill trunk muscle endurance test
The McGill trunk muscle endurance test is a test group that includes all trunk flexor, extensor and lateral muscle endurance tests.
Measured: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Secondary outcomes (2)
Health assessment questionnaire (HAQ)
This questionnaire consists of 20 questions and 8 subheadings, each answer ranging from 0 to 3 points.
Measured: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Cognitive Exercise Therapy Approach (BETY)
This scale has 30 items. The scale is scored with a 5-point Likert system.
Measured: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start5 Feb 2025
- Primary completion5 Apr 2025 (estimated)
- Study completion5 Jun 2025 (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 Sjogren SyndromeStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Begüm AKAR, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879444
- Sponsor's protocol ID
- Pamukkale U
- Status last verified
- Feb 2025
- First submitted
- 24 Feb 2025
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akar B, Kabul EG, Calik BB, Bozcuk S, Cobankara V. Investigation of Core Stabilization Strength and Pelvic Floor Functions in Patients with Primary Sjogren's Syndrome: A Case-Control Study. Int Urogynecol J. 2026 Jun;37(6):1641-1652. doi: 10.1007/s00192-025-06467-6. Epub 2026 Jan 15.
PubMed 41538013
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Investigation of 'Core' Stabilization Strength and Pelvic Floor Functions in Individuals with Primary Sjogren: a Controlled Study"
- ClinicalTrials.gov ID
- NCT06879444
- Acronym / sponsor ID
- Pamukkale U
- Conditions
- Sjogren Syndrome, Healthy Volunteers
- Keywords
- pelvic floor, core stabilization, Sjogren syndrome
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- 5 Apr 2025 (estimated)
- Study completion
- 5 Jun 2025 (estimated)
- First posted
- 17 Mar 2025 (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.
This study aims to explain the comparison of core stabilization strength and pelvic floor functions between individuals diagnosed with Sjogren syndrome and a healthy control group.
(Sjogren syndrome group n=27; control group n=27)
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | – | Other: Core Muscle testing and patient reported outcome measuresThe control group will consist of healthy volunteers. |
| Sjogren syndrome | – | Other: Core Muscle testing and patient reported outcome measuresThe Sjogren syndrome group will consist of patients aged between 18-65 who apply to the Rheumatology Department of Pamukkale University and meet the inclusion criteria. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Sjogren syndrome group and control group
Key inclusion criteria (6 listed)
- Diagnosed by a rheumatologist
- Being 18 years of age or older,
- Agreeing to participate in the study
- -Being 18 years of age or older,
Key exclusion criteria (4 listed)
- Presence of neurological disease
- Presence of any orthopedic problem that would affect functionality
- Presence of a history of orthopedic surgery
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 |
|---|---|---|
| Core Muscle testing and patient reported outcome measuresThese are the situation evaluation parameters. It presents the data of the participants at the time of evaluation. | Other | Sjogren syndrome, control group |
Primary outcome
Pelvic Floor Distress Inventory-20 (PTDE-20)
Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
There are 20 questions in total on the scale. The best score that can be obtained from the entire survey is "0" and the worst score is "300".
Sexual Life Quality Scale- Women (CYKÖ-K)
Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
The maximum score that can be obtained from the scale with this system is 108.
Incontinence Impact Questionnaire (IIQ-7) (IES)
Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Consists of 7 items. Maximum score is 100.
The McGill trunk muscle endurance test
Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
The McGill trunk muscle endurance test is a test group that includes all trunk flexor, extensor and lateral muscle endurance tests.
2 secondary outcomes
Health assessment questionnaire (HAQ)
Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Cognitive Exercise Therapy Approach (BETY)
Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Derived from this study: PubMed 41538013Akar B, Kabul EG, Calik BB, Bozcuk S, Cobankara V. Investigation of Core Stabilization Strength and Pelvic Floor Functions in Patients with Primary Sjogren's Syndrome: A Case-Control Study. Int Urogynecol J. 2026 Jun;37(6):1641-1652. doi: 10.1007/s00192-025-06467-6. Epub 2026 Jan 15.
- Individual participant dataSharing planned: No
Related trials for Sjogren Syndrome
RecruitingPhase 2
Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren Disease
Sjogren's Syndrome
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruitingObservational study
Possible Sarcopenia, Sarcopenia, and Functional Status in Patients With Primary Sjögren's Syndrome
Primary Sjögren Syndrome, Sarcopenia
RecruitingPhase 1
A Clinical Study of YTS109 Cells for the Treatment of R/R Autoimmune Diseases
Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN)
Active, not recruitingPhase 2
Autologous Serum Obtained by a Closed-Circuit Collection Device
GVHD, Meibomian Gland Dysfunction (Disorder)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sjogren Syndrome and Healthy Volunteers, run by Pamukkale 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 6 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: enrolling by invitation, as of the sponsor's last update on 17 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic Floor Distress Inventory-20 (PTDE-20) (time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.). The study lists 4 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 NCT06879444, 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 17 Mar 2025.