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Enrolling by invitation NCT06879444

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

Observational Sjogren Syndrome Healthy Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Core Muscle testing and patient reported outcome measures.
Who it may be relevant to
Registry conditions: Sjogren Syndrome, Healthy Volunteers. Basic parameters: 18 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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)

Interventions

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

Primary outcome measures

  • 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.]
  • 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.]
  • 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.]
  • 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.]
Secondary outcome measures (2)
  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Turkey (Türkiye) · 1 center
  • Pamukkale Üniversitesi — Denizli

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. PMID 41538013

Identifiers

NCT: NCT06879444 · Pamukkale U

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗