PregnancyNCT06869538
Effect of Pilates and Kegel Exercises During Pregnancy
An observational study of Pregnancy, run by Hitit University at 1 site in Turkey (Türkiye).
Trial summary
Urinary incontinence and fecal incontinence are common health problems in the postpartum period because of their effect on daily life and are likely to reduce quality of life. It is known that the most effective way to protect from UI during pregnancy and the postpartum period is pelvic floor muscle exercise. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Exercise
- How many people
- 67 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2021to 13 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 38 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnancy women
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pilates and Kegel Exercises During Pregnancy on Postpartum Urinary and Fecal Incontinence and Women's Quality of Life
Urinary incontinence and fecal incontinence are common health problems in the postpartum period because of their effect on daily life and are likely to reduce quality of life. It is known that the most effective way to protect from UI during pregnancy and the postpartum period is pelvic floor muscle exercise. This study aimed to investigate the effects of Pilates and Kegel exercises applied during pregnancy on the quality of life of urinary and fecal incontinence in the postpartum period.
Read the detailed description
In this study; the effects of pilates and kegel exercises on urinary and fecal incontinence of pregnant women in the 1st and 3rd months postpartum are investigated and which of the applied pilates and kegel exercises is more effective on urinary and fecal quality of life.67 pregnant women with a mean age of 27.29±3.27 years participated in the study. Pilates exercise group (PEG, n=24), Kegel exercise group (KEG, n=22), and Control group (CG, n=21) were formed with the purposeful method. PEG exercise programs were applied for 8 weeks, 2 days a week, 40 minutes, and KEG for 8 weeks, 4 days a week, 3 sessions per day. The groups were applied the International Incontinence Questionnaire Short Form, Urinary Incontinence Quality of Life Scale, Wexner Continence Assessment Scale, and Fecal Incontinence Quality of Life Scale at 1st. and 3rd. months postpartum
- Conditions
- Pregnancy
- Being tested
- Exercise
- Keywords
- Urinary İncontinence, Fecal İncontiance, Quality Of Life, pregnancy, exercise
- Medical subject headings
- Nocturnal Enuresis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
For the Pilates exercises, a Pilates instructor created movements (squeeze mini ball, stretch hoop, circle with large ball, back and forth with large ball, and squat) in the gymnasium of the pregnancy school for 8 weeks, 2 days a week. Auxiliary equipment (mini ball, resistance band, Pilates ring) was used. Kegel exercises were performed 4 days a week, 3 sessions a day for 8 weeks.
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Anthropometric Measurements (Weight, Height, BMI)
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
Measured: 2021 june
Urinary Incontinence Quality of Life Scale (I-QOL)-Baseline and Follow-up Measurements
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.
Measured: June 2021 (Baseline) and 1st and 3rd months postpartum
Effect of an 8-Week Exercise Intervention on Urinary and Fecal Incontinence - Measured by ICIQ-UI Short Form and Wexner Continence Assessment Scale
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
Measured: Baseline (June 2021), Post-intervention (August 2021), and Follow-up at 1st and 3rd months postpartum.
International Incontinence Questionnaire Short Form Score (ICIQ-SF) - Urinary Incontinence Impact
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.
Measured: 2021 September 2021 November
Wexner Continence Assessment Scale Score - Fecal Incontinence Severity
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.
Measured: September 2021 - November 2021
Fecal Incontinence Quality of Life Scale (FIQL) Score
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
Measured: September 2021 - November 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start15 Jun 2021
- Primary completion5 Nov 2021
- Study completion13 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guner CICEK, Hitit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869538
- Sponsor's protocol ID
- 469
- Other IDs
- Hitit University
- Status last verified
- Mar 2025
- First submitted
- 8 Feb 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make IPD and related data dictionaries available
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pilates and Kegel Exercises During Pregnancy on Postpartum Urinary and Fecal Incontinence and Women's Quality of Life
- ClinicalTrials.gov ID
- NCT06869538
- Acronym / sponsor ID
- 469
- Conditions
- Pregnancy
- Keywords
- Urinary İncontinence, Fecal İncontiance, Quality Of Life, pregnancy, exercise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 5 Nov 2021 (actual)
- Study completion
- 13 Feb 2022 (actual)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Urinary incontinence and fecal incontinence are common health problems in the postpartum period because of their effect on daily life and are likely to reduce quality of life. It is known that the most effective way to protect from UI during pregnancy and the postpartum period is pelvic floor muscle exercise. This study aimed to investigate the effects of Pilates and Kegel exercises applied during pregnancy on the quality of life of urinary and fecal incontinence in the postpartum period.
Detailed description
In this study; the effects of pilates and kegel exercises on urinary and fecal incontinence of pregnant women in the 1st and 3rd months postpartum are investigated and which of the applied pilates and kegel exercises is more effective on urinary and fecal quality of life.67 pregnant women with a mean age of 27.29±3.27 years participated in the study. Pilates exercise group (PEG, n=24), Kegel exercise group (KEG, n=22), and Control group (CG, n=21) were formed with the purposeful method. PEG exercise programs were applied for 8 weeks, 2 days a week, 40 minutes, and KEG for 8 weeks, 4 days a week, 3 sessions per day. The groups were applied the International Incontinence Questionnaire Short Form, Urinary Incontinence Quality of Life Scale, Wexner Continence Assessment Scale, and Fecal Incontinence Quality of Life Scale at 1st. and 3rd. months postpartum
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnancy women
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseFor the Pilates exercises, a Pilates instructor created movements (squeeze mini ball, stretch hoop, circle with large ball, back and forth with large ball, and squat) in the gymnasium of the pregnancy school for 8 weeks, 2 days a week. Auxiliary equipment (mini ball, resistance band, Pilates ring) was used. Kegel exercises were performed 4 days a week, 3 sessions a day for 8 weeks. | Other | – |
Primary outcome
Baseline Anthropometric Measurements (Weight, Height, BMI)
Time frame: 2021 june
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
Urinary Incontinence Quality of Life Scale (I-QOL)-Baseline and Follow-up Measurements
Time frame: June 2021 (Baseline) and 1st and 3rd months postpartum
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.
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.
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
International Incontinence Questionnaire Short Form Score (ICIQ-SF) - Urinary Incontinence Impact
Time frame: 2021 September 2021 November
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.
Wexner Continence Assessment Scale Score - Fecal Incontinence Severity
Time frame: September 2021 - November 2021
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.
Fecal Incontinence Quality of Life Scale (FIQL) Score
Time frame: September 2021 - November 2021
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. There is a plan to make IPD and related data dictionaries available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Hitit University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline Anthropometric Measurements (Weight, Height, BMI) (time frame: 2021 june). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.