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Enrolling by invitationNCT06879444Updated Mar 17, 2025

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

An observational study in Sjogren Syndrome and Healthy Volunteers, sponsored by Pamukkale University. Enrolling by invitation at 1 site in Turkey. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-17.

Sponsored by Pamukkale University · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 6 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
10
Ages
18 Years to 65 Years
Sex
Female
01

Study 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)

02

Conditions studied

  • Sjogren Syndrome
  • Healthy Volunteers

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Keywords

  • pelvic floor
  • core stabilization
  • Sjogren syndrome
03

In context

Sjogren's Syndrome

371 studies on the registry are indexed under Sjogren's Syndrome; 104 are open to participants now.

This study's planned enrollment of 10 is below the median of 114 across 113 observational studies indexed under Sjogren's Syndrome.

Browse Sjogren's Syndrome studies →

Lead sponsor

Pamukkale University is the lead sponsor of 331 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Sjogren syndrome group and control group

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

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
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
10 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherCore 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.

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What researchers measure

Primary outcomes

  1. 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".

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

  2. Sexual Life Quality Scale- Women (CYKÖ-K)

    The maximum score that can be obtained from the scale with this system is 108.

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

  3. Incontinence Impact Questionnaire (IIQ-7) (IES)

    Consists of 7 items. Maximum score is 100.

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

  4. 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.

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

Secondary outcomes

  1. Health assessment questionnaire (HAQ)

    This questionnaire consists of 20 questions and 8 subheadings, each answer ranging from 0 to 3 points.

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

  2. Cognitive Exercise Therapy Approach (BETY)

    This scale has 30 items. The scale is scored with a 5-point Likert system.

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

07

Study locations

1 site
  • Pamukkale Üniversitesi
    Denizli, 20000, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06879444
Lead sponsor
Pamukkale University
Responsible party
Begüm AKAR (Principal investigator, Pamukkale University) — Principal investigator
First posted
Mar 17, 2025
Start date
Feb 5, 2025
Primary completion
Apr 5, 2025 (estimated)
Completion
Jun 5, 2025 (estimated)
Last update
Mar 17, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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