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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • Batman, Turkey, 72000
        • Batman University
      • Batman, Turkey
        • Türkiye
    • Gültepe
      • Batman, Gültepe, Turkey, 72000
        • Batman Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other: PİLATES GROUP
A total of 16 sessions were applied for 8 weeks, 2 sessions per week.
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.
Other: Behavioral: lifestyle changes
presentation including lifestyle changes was prepared and training was provided.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Menopause Rating Scale (MRS)
Time Frame: 8 week
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.
8 week
Menopausal-Specific Quality of Life Scale (MENQOL)
Time Frame: 8 week
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.
8 week
Female Sexual Function Index (FSFI)
Time Frame: 8 week
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.
8 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Batman University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 5, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 10, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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