- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06869538
Effect of Pilates and Kegel Exercises During Pregnancy
Effect of Pilates and Kegel Exercises During Pregnancy on Postpartum Urinary and Fecal Incontinence and Women's Quality of Life
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Central
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Corum, Central, Turkey, 19030
- Hitit University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclucision Criteria
- Being between the ages of 18-38 years,
- Not having a condition that prevents exercise,
- Being in the 3rd trimester of pregnancy,
- Voluntarily accepting to participate in the study, a
- Answering each of the scale items,
- Having a vaginal (normal) birth.
Exclusion Criteria:
- Not being between the ages of 18-38,
- Having a condition that prevents exercise,
- Not being in the 1st and 2nd trimesters of pregnancy,
- Leaving scale items blank, and having a cesarean section.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Baseline Anthropometric Measurements (Weight, Height, BMI)
Time Frame: 2021 june
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Baseline meausurement ( 1 week) Participants will be evaluated at baseline.
Data collection refers to anthropometric parameters (Weight, height and BMI.
BMI BMI will calculated as weight in kilograms divided by height squared (kg/m2) in meters
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2021 june
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Urinary Incontinence Quality of Life Scale (I-QOL)-Baseline and Follow-up Measurements
Time Frame: June 2021 (Baseline) and 1st and 3rd months postpartum
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Urinary Incontinence Quality of Life Scale (I-QOL) - Evaluates the quality of life related to urinary incontinence. Description: Evaluates the quality of life related to urinary incontinence. This scale was applied at baseline and at the 1st and 3rd months postpartum. Minimum Value: 0 (Poor quality of life) Maximum Value: 100 (High quality of life) Higher Scores Indicate: Better quality of life Data Aggregation: Mean ± SD and comparison of scores between groups using ANOVA. |
June 2021 (Baseline) and 1st and 3rd months postpartum
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Effect of an 8-Week Exercise Intervention on Urinary and Fecal Incontinence - Measured by ICIQ-UI Short Form and Wexner Continence Assessment Scale
Time Frame: Baseline (June 2021), Post-intervention (August 2021), and Follow-up at 1st and 3rd months postpartum.
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This measure evaluates the effect of an 8-week exercise intervention on urinary and fecal incontinence in pregnant women. Urinary incontinence severity will be assessed using the ICIQ-UI SF, and fecal incontinence using the Wexner Scale at baseline, post-intervention (8 weeks), and 1st and 3rd months postpartum. Participants are divided into two groups: Pilates Group (PEG): Performed Pilates twice a week, 40 minutes per session, for 8 weeks, using a mini ball, resistance band, and Pilates ring. Kegel Group (KEG): Performed Kegel exercises 4 days a week, 3 sessions per day, for 8 weeks, involving controlled pelvic floor contractions and relaxations. Measurement Tools: Urinary Incontinence: ICIQ-UI SF Fecal Incontinence: Wexner Scale |
Baseline (June 2021), Post-intervention (August 2021), and Follow-up at 1st and 3rd months postpartum.
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International Incontinence Questionnaire Short Form Score (ICIQ-SF) - Urinary Incontinence Impact
Time Frame: 2021 September 2021 November
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Description: Assesses the impact of urinary incontinence on daily life.
Minimum Value: 0 (No impact) Maximum Value: 21 (Severe impact) Higher Scores Indicate: Worse quality of life Data Aggregation: Mean ± SD and comparison of groups using repeated measures ANOVA, paired t-test for pre- and post-intervention comparison.
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2021 September 2021 November
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Wexner Continence Assessment Scale Score - Fecal Incontinence Severity
Time Frame: September 2021 - November 2021
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Description: Measures the severity of fecal incontinence.
Minimum Value: 0 (Complete continence) Maximum Value: 20 (Complete incontinence) Higher Scores Indicate: Worse fecal incontinence Data Aggregation: Mean ± SD and comparison of groups using repeated measures ANOVA, paired t-test for pre- and post-intervention comparison.
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September 2021 - November 2021
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Fecal Incontinence Quality of Life Scale (FIQL) Score
Time Frame: September 2021 - November 2021
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Description: Assesses the quality of life related to fecal incontinence.
Minimum Value: 1 (Poor quality of life) Maximum Value: 5 (High quality of life) Higher Scores Indicate: Better quality of life Data Aggregation: Mean ± SD and comparison of groups using repeated measures ANOVA, paired t-test for pre- and post-intervention comparison
|
September 2021 - November 2021
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 469
- Hitit University (Other Identifier: Hitit University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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