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

"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)

Study Overview

• Status: Enrolling by invitation
• Conditions: Healthy Volunteers; Sjogren Syndrome
• Intervention / Treatment: Other: Core Muscle testing and patient reported outcome measures

• Study Type: Observational
• Enrollment (Estimated): 10

Contacts and Locations

Study Locations

• Turkey
  • Denizli, Turkey, 20000
    • Pamukkale Üniversitesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Sjogren syndrome group and control group

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
control group; The control group will consist of healthy volunteers.	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.
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; These are the situation evaluation parameters. It presents the data of the participants at the time of evaluation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health assessment questionnaire (HAQ)	This questionnaire consists of 20 questions and 8 subheadings, each answer ranging from 0 to 3 points.	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.	Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

Collaborators and Investigators

• Sponsor: Pamukkale University

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2025
• Primary Completion (Estimated): April 5, 2025
• Study Completion (Estimated): June 5, 2025

Study Registration Dates

• First Submitted: February 24, 2025
• First Submitted That Met QC Criteria: March 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 13, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: core stabilization; pelvic floor; Sjogren syndrome
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Mouth Diseases; Stomatognathic Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Eye Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Sjogren's Syndrome
• Other Study ID Numbers: Pamukkale U

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No