"Core Stabilization Strenght and Pelvic Floor Functions in Primary Sjogren's"

NCT06879444 — Enrolling by invitation, 10 participants, Pamukkale University

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

"Investigation of 'Core' Stabilization Strength and Pelvic Floor Functions in Individuals with Primary Sjogren: a Controlled Study"

Registry	NCT06879444
Status	Enrolling by invitation
Study type	Observational
Enrollment	10 (Estimated)
Sponsor	Pamukkale University (Other)
Conditions	Sjogren Syndrome, Healthy Volunteers
Interventions	Core Muscle testing and patient reported outcome measures (Other)
Dates	start 2025-02-05, primary completion 2025-04-05 (estimated), completion 2025-06-05 (estimated), first posted 2025-03-17, last updated 2025-03-17
Locations	1 site in Turkey (Türkiye)

-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)

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
control group		Other: Core Muscle testing and patient reported outcome measures	The control group will consist of healthy volunteers.
Sjogren syndrome		Other: Core Muscle testing and patient reported outcome measures	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.

Core Muscle testing and patient reported outcome measures (Other): These are the situation evaluation parameters. It presents the data of the participants at the time of evaluation.

+Outcome measures

Primary outcomes

Pelvic Floor Distress Inventory-20 (PTDE-20) [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) [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) [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 [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.

Secondary outcomes

Health assessment questionnaire (HAQ) [Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.]: This questionnaire consists of 20 questions and 8 subheadings, each answer ranging from 0 to 3 points.
Cognitive Exercise Therapy Approach (BETY) [Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.]: This scale has 30 items. The scale is scored with a 5-point Likert system.

+Eligibility

Sex: Female, ages: 18 Years to 65 Years, accepts healthy volunteers

Inclusion Criteria:

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,

Exclusion Criteria:

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

+Locations (1)

Facility	City	Country	Status
Pamukkale Üniversitesi	Denizli, Denizli	Turkey (Türkiye)

+Publications

Results publication: 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. PMID 41538013