Menopausal SyndromeNCT06837714
Investigation of the Effects of Pilates Exercises on Menopause Symptoms and Sexual Dysfunction in Postmenopausal Women
A study testing PİLATES GROUP and Behavioral: lifestyle changes in people with Menopausal Syndrome and Sexual Dysfunctions, run by Batman University at 3 sites in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopausal Syndrome, Sexual Dysfunctions, Quality of Life and Menopause
- What is being tested?
- PİLATES GROUP and Behavioral: lifestyle changes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 15 Sep 2023to 10 Oct 2024
- Phase
- Interventional
- 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 45 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women who have reached menopause
- Being physically or cognitively competent to exercise
- Those who agreed to participate in the study
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Turkey (Türkiye)3 sites
Batman Center
Batman, Gültepe, 72000
Batman university
Batman, 72000
Türkiye
Batman
About this study
Official title: 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.
Read the 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.
- Being tested
- PİLATES GROUP, Behavioral: lifestyle changes
- Keywords
- postmenopause, pilates, menopausal syndrome, sexual dysfunctions, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PİLATES GROUPOther
A total of 16 sessions were applied for 8 weeks, 2 sessions per week.
Behavioral: lifestyle changesOther
presentation including lifestyle changes was prepared and training was provided.
| Study group | Role | What they receive |
|---|---|---|
| pilates group | Active comparator | 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 Receives: Other: PİLATES GROUP |
| group that includes lifestyle changes | Active comparator | . 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. Receives: Other: Behavioral: lifestyle changes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menopause Rating Scale (MRS)
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.
Measured: 8 week
Menopausal-Specific Quality of Life Scale (MENQOL)
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.
Measured: 8 week
Female Sexual Function Index (FSFI)
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.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start15 Sep 2023
- Primary completion5 Mar 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Menopausal SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. Reformer pilates group 2. Group that includes lifestyle changes
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Batman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, merve yiğit kocamer, Batman University
- Investigators
- YİĞİT KOCAMER MERVE, Principal investigator, Batman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837714
- Sponsor's protocol ID
- BAU-FTR-MYK-01
- Status last verified
- Feb 2025
- First submitted
- 17 Dec 2024
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yigit Kocamer M, Atilgan E. Investigating the effects of Pilates exercises on menopausal symptoms and sexual dysfunction in postmenopausal women: A randomized controlled trial. Medicine (Baltimore). 2025 Jun 6;104(23):e42689. doi: 10.1097/MD.0000000000042689.
PubMed 40489883
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Pilates Exercises on Menopausal Symptoms and Sexual Dysfunction in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT06837714
- Acronym / sponsor ID
- BAU-FTR-MYK-01
- Keywords
- postmenopause, pilates, menopausal syndrome, sexual dysfunctions, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Batman UniversityUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 5 Mar 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 20 Feb 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1. Reformer pilates group 2. Group that includes lifestyle changes
| Arm | Type | Receives |
|---|---|---|
| pilates group | Active comparator | Other: PİLATES GROUPThe 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 |
| group that includes lifestyle changes | Active comparator | Other: Behavioral: 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. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women who have reached menopause
- Being physically or cognitively competent to exercise
- Those who agreed to participate in the study
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| PİLATES GROUPA total of 16 sessions were applied for 8 weeks, 2 sessions per week. | Other | pilates group |
| Behavioral: lifestyle changespresentation including lifestyle changes was prepared and training was provided. | Other | group that includes lifestyle changes |
Primary outcome
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.
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.
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.
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 20 Feb 2025.
- Derived from this study: PubMed 40489883Yigit Kocamer M, Atilgan E. Investigating the effects of Pilates exercises on menopausal symptoms and sexual dysfunction in postmenopausal women: A randomized controlled trial. Medicine (Baltimore). 2025 Jun 6;104(23):e42689. doi: 10.1097/MD.0000000000042689.
- Individual participant dataSharing planned: No
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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.
YİĞİT KOCAMER MERVE principal investigator
Batman University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PİLATES GROUP and Behavioral: lifestyle changes in people with Menopausal Syndrome and Sexual Dysfunctions, run by Batman University at 3 sites 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 3 inclusion and 5 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 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Menopause Rating Scale (MRS) (time frame: 8 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06837714, which also lists 1 linked publication.
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 20 Feb 2025.