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

NCT06879444 | Enrolling By Invitation

• 1 other identifier: Pamukkale U
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Sjogren Syndrome; Healthy Volunteers

Keywords

pelvic floor; core stabilization; Sjogren syndrome

Outcome Measures

Primary Outcomes (4)

• 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".

  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.

  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.

  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.

  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)

  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)

  Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

Study Arms (2)

control group

The control group will consist of healthy volunteers.

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.

Other: Core Muscle testing and patient reported outcome measures

Interventions

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.

Sjogren syndrome; control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Sjogren syndrome group and control group

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale Üniversitesi

Denizli, Denizli, 20000, Turkey (Türkiye)

Location

Related Publications (1)

• 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 Jan 15. doi: 10.1007/s00192-025-06467-6. Online ahead of print.

  PMID: 41538013 DERIVED

MeSH Terms

Conditions

Sjogren's Syndrome

Interventions

Patient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 17, 2025
• Study Start: February 5, 2025
• Primary Completion: April 5, 2025
• Study Completion: June 5, 2025
• Last Updated: March 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)