- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06837714
Investigation of the Effects of Pilates Exercises on Menopause Symptoms and Sexual Dysfunction in Postmenopausal Women
February 19, 2025 updated by: merve yiğit kocamer, Batman University
Investigation of the Effects of Pilates Exercises on Menopausal Symptoms and Sexual Dysfunction in Postmenopausal Women
Menopause represents a major transition in a woman's life as estrogen and progesterone levels decline, and this hormonal shift is associated with a range of symptoms that can significantly impact a woman's quality of life, including vasomotor symptoms such as hot flushes and night sweats, and urogenital symptoms such as vaginal dryness and sexual dysfunction.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
This study aimed to investigate the effects of Pilates exercises on menopausal symptoms and sexual dysfunction in postmenopausal women.
The research seeks to understand how an 8-week Pilates program, conducted twice a week, influences the quality of life and sexual function during the postmenopausal period.
A total of 30 postmenopausal women were included in this study, divided into a Pilates group and a control group.
The Pilates group participated in an 8-week Pilates exercise program, while the control group received no exercise intervention but attended menopause information sessions.
Data were collected using the Menopause Rating Scale (MRS), the Menopausal-Specific Quality of Life Scale (MENQOL), and the Female Sexual Function Index (FSFI) before and after the intervention.
Body Mass Index (BMI) was recorded, but not used in the primary analysis.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Batman, Turkey, 72000
- Batman University
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Batman, Turkey
- Türkiye
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Gültepe
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Batman, Gültepe, Turkey, 72000
- Batman Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Women who have reached menopause
- Being physically or cognitively competent to exercise
- Those who agreed to participate in the study
Exclusion Criteria:
- Those with serious heart disease, DM, kidney, liver, thyroid disease and cancer patients
- Those receiving hormone therapy
- People using antipsychotic medication
- Those using steroids and derivative drugs
- People using insulin sensitizing drugs Those with musculoskeletal system diseases that would prevent them from exercising Cognitive problems that affect cooperation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: pilates group
The Pilates intervention group participated in an 8-week Pilates exercise program.
The program consisted of sessions held twice a week, each lasting approximately 60 minutes.
The Pilates exercises focused on core stability, flexibility, balance, and controlled breathing, and were tailored to accommodate the fitness levels of the participants.
Each session was conducted by a certified Pilates instructor who ensured proper technique and safety during the exercises
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A total of 16 sessions were applied for 8 weeks, 2 sessions per week.
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Active Comparator: group that includes lifestyle changes
. The control group did not engage in any structured exercise program during the 8-week period.
Instead, they attended a menopause information session where they received education on menopause-related issues, including symptom management, lifestyle modifications, and general health tips for postmenopausal women.
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presentation including lifestyle changes was prepared and training was provided.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Menopause Rating Scale (MRS)
Time Frame: 8 week
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This scale was used to assess the severity of menopausal symptoms experienced by the participants.
The MRS covers a range of symptoms, including vasomotor, psychological, and urogenital symptoms.
Participants rated the severity of each symptom on a Likert scale, with higher scores indicating more severe symptoms.
The total score of the scale is calculated with the scores obtained from each item.
The lowest score calculated from the scale is "0" while the highest score is "44".
The scale covering menopausal symptoms consists of 11 items and 3 sub-dimensions.
The sub-dimensions are somatic complaints (items 1, 2, 3 and 11), psychological complaints (items 4, 5, 6 and 7), urogenital complaints (items 8, 9 and 10).
An increase in the total score obtained from the scale indicates an increase in the severity of the complaints experienced and, in addition, a negative impact on the quality of life.
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8 week
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Menopausal-Specific Quality of Life Scale (MENQOL)
Time Frame: 8 week
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This scale measures the impact of menopausal symptoms on quality of life across several domains, including physical, psychological, and sexual well-being.
The MENQOL provides a comprehensive assessment of how menopausal symptoms affect daily life, with higher scores indicating a greater negative impact.MENQOL is a Likert-type scale containing 32 questions.
It consists of four sub-areas: vasomotor, psychosocial, physical and sexual.
Each sub-area score in MENQOL is ranked from 1 to 8. A score of one indicates that no problem is experienced regarding that issue, a score of two indicates that the issue exists, is experienced but is not disturbing at all, while scores between 3 and 8 indicate the severity and increasing degrees of the existing problem.
The maximum score is 256, and the minimum score is 32.
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8 week
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Female Sexual Function Index (FSFI)
Time Frame: 8 week
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The FSFI was used to evaluate sexual function, focusing on domains such as sexual desire, arousal, lubrication, orgasm, satisfaction, and pain.
Participants were asked to rate their experiences in each domain over the past 4 weeks.
Higher FSFI scores indicate better sexual function.The highest raw score that can be obtained from the survey is 95, and the lowest is 4. The total score obtained from the survey shows that there is an improvement in all parameters as the scores obtained from the parameters of sexual desire, arousal, lubrication, orgasm, and general satisfaction increase.
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8 week
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: YİĞİT KOCAMER MERVE, Batman University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 15, 2023
Primary Completion (Actual)
March 5, 2024
Study Completion (Actual)
October 10, 2024
Study Registration Dates
First Submitted
December 17, 2024
First Submitted That Met QC Criteria
February 19, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 19, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- BAU-FTR-MYK-01
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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