MenopausalNCT06996743
Effect of Pilates Exercises on Menopausal Symptoms
A study testing reformer pilates group, Mat pilates group and Lifestyle change group in people with Menopausal and Obese Patients, run by Batman University at 2 sites in Turkey (Türkiye).
Trial summary
Menopause, a significant transition in a woman's life characterized by the cessation of menstruation and a decline in ovarian function, leads to reduced levels of estrogen and progesterone. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Menopausal, Obese Patients, Pilates Exercise
- What is being tested?
- reformer pilates group, Mat pilates group and Lifestyle change group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 5 Sep 2023to 20 Mar 2025
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women who have entered menopause
- Being diagnosed with obesity (30 kg/m2 ≤ BMI ≤ 40 kg/m2 )
- Having the physical or cognitive ability to exercise
- Being sedentary ('International Physical Activity Questionnaire' will be used. Those in the Inactive Category group will be included.)
- Those who agree to participate in the study
Who cannot join
- BMI below 30
- Those with serious heart disease, DM, kidney, liver, thyroid disease and cancer
- Those receiving hormone therapy
- Those using antipsychotic drugs
- Those using steroids and derivatives
- Those using insulin-sensitizing drugs
- Those with musculoskeletal diseases that will prevent exercise • Cognitive problems that will affect cooperation
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Batman Center
Batman, Gültepe, 72000
Batman
Batman
About this study
Official title: Effect of Pilates Exercises on Menopausal Symptoms in Postmenopausal Obesity
Menopause, a significant transition in a woman's life characterized by the cessation of menstruation and a decline in ovarian function, leads to reduced levels of estrogen and progesterone. This hormonal shift is associated with a range of symptoms that can adversely affect women's quality of life, including vasomotor symptoms such as hot flashes and night sweats, psychological symptoms like mood swings and depression, as well as urogenital symptoms such as vaginal dryness and sexual dysfunction. These symptoms, collectively referred to as menopausal symptoms, can vary in severity and duration and frequently require intervention to alleviate their impact on daily life.
Read the detailed description
The aim of our study was to determine the effect of pilates exercises on menopausal symptoms in postmenopausal obesity and to compare it with the control group. The study was designed as a single-blind randomized controlled trial. 45 obese individuals in the postmenopausal period were included in the study. The patients were randomly divided into 3 groups and a total of 16 treatment sessions were applied to both groups for 8 weeks, 2 days a week. No exercise intervention was applied to the control group. Reformer Pilates exercises were applied to Group 1, and mat Pilates exercises were applied to Group 2. A physical activity-based brochure including lifestyle changes was distributed to Group 3. A total of two evaluations were made before and after exercise. In the evaluation, the Menopausal Symptoms RatingScale (MRS) for menopausal symptoms, the Menopause-Specific Quality of Life Assessment Scale (MENQOL) for quality of life assessment, the Beck Depression Inventory (BDI) for depression, the Pittsburgh Sleep Quality Index (PSQI) for assessing sleep quality, the Six-Minute Walking Test (6 MWT) for assessing aerobic capacity, the Body Analysis Scale (TANITA) for assessing body composition, and laboratory analyses of blood samples taken for assessing blood lipid profile were used. Statistical analyses were performed to compare the data.
- Being tested
- reformer pilates group, Mat pilates group, Lifestyle change group
- Keywords
- menopause, obese women, pilates exercises, blood lipid profile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reformer pilates groupOther
Reformer Pilates exercises were applied to the pilates group twice a week for a total of 8 weeks.
Mat pilates groupOther
Mat Pilates exercises were applied to the pilates group twice a week for a total of 8 weeks.
Lifestyle change groupOther
After the doctor's check-up, routine application continued. The patient was informed about physical activity. In addition; a physical activity-based brochure prepared by the Specialist Physiotherapist was distributed to the participants in this group.
| Study group | Role | What they receive |
|---|---|---|
| reformer pilates group | Active comparator | It was done by a specialist physiotherapist on a Pilates reformer device, and the exercises lasted approximately 60 minutes. The exercise content consists of strengthening exercises, stretching exercises, and warm-up and cool-down exercises.
The program was updated with the addition of a new exercise type every two weeks.
The repetition numbers were updated to 8 repetitions in the first two weeks, 10 repetitions in the third and fourth weeks, and 12 repetitions in the last four weeks. Receives: Other: reformer pilates group |
| 2- Mat pilates group | Active comparator | The special exercises in the reformer pilates program were applied as structured mat pilates. First, the exercises to be done by the physiotherapist were taught. Then, an illustrated brochure with the exercises was prepared by the expert physiotherapist and distributed to the participants in this group. In order for the exercise to be done correctly and effectively, a video shot by the expert physiotherapist was sent to the patients in addition to the brochure. Each exercise was explained in detail in the video and the tricks were mentioned. The patient did the exercises at home. Online control was provided via smartphone once a week and the exercises were done under the observation of the expert physiotherapist during the online interview. The exercise follow-up chart was filled out regularly twice every week. The exercise duration lasted approximately 60 minutes. The program was updated with the addition of a new exercise type every two weeks and continued in its fixed form for the Receives: Other: Mat pilates group |
| 3- Lifestyle change group | Active comparator | After the doctor's check-up, routine application continued. The patient was informed about physical activity. In addition; a physical activity-based brochure prepared by the Specialist Physiotherapist was distributed to the participants in this group. The brochure included methods for coping with menopause and lifestyle changes to reduce symptoms. Receives: Other: Lifestyle change group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menopause Symptoms Assessment Scale (MSAS)
The Menopause Symptoms Assessment Scale (MSS) is a very useful tool for assessing the symptoms of women in menopause and measuring their impact on their quality of life. Using a Likert-type scale, determining the severity of symptoms provides important data for treatment and intervention planning.
In particular, being organized in 3 sub-dimensions (somatic, psychological and urogenital complaints) helps understand the different aspects of menopause. This diversity provides a comprehensive assessment for both health professionals and researchers. The Likert-type scale, which includes menopausal complaints, is scored between 0 and 4. It indicates that the complaint is not present at all, while 4 indicates that it is very severe. The total score of the scale is calculated with the scores obtained from each item.high score indicates negativity
Measured: 8 week
Menopause-Specific Quality of Life Scale (MSQLS)
The Menopause-Specific Quality of Life Scale (MSQLS) is a comprehensive tool that multi-dimensionally assesses the quality of life of women in the menopausal process. Developed by Hilditch and colleagues, this scale focuses on the physical, psychosocial, sexual and vasomotor symptoms of menopause, revealing the impact of different symptoms on quality of life in more detail.
Especially the Likert-type assessment consisting of 32 questions and scored from 1 to 8 is very useful in examining the severity of problems in the menopausal process. Such a scale is an important tool for understanding the difficulties experienced by women in the menopausal period and for making appropriate interventions. The scoring of each subdomain helps determine the degree to which problems specific to that subject cause discomfort, which allows for more effective development of treatment and support plans. The lowest score is 8 and the highest score is 256. High score indicates negativity
Measured: 8 week
Secondary outcomes (5)
Beck Depression Inventory
The Beck Depression Inventory (BDI) is a tool that can effectively assess the severity of depression and changes in an individual's mood. Developed in 1961 by Aaron T. Beck and his colleagues, it specifically measures how individuals feel, focusing on the cognitive and emotional dimensions of depression.
There are 21 questions in total, the item is scored between 0-3 and provides information about different levels of depression. The BDI, which is measured with a minimum score of 0 and a maximum score of 63 points, is a highly functional method for determining the severity of depression. A high score indicates increased violence, which is a negative situation.
Measured: 8 week
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is an effective scale with a wide scope for assessing sleep quality. Developed in 1989 by Buysse and colleagues, this scale consists of a series of questions aimed at understanding various dimensions of sleep and offers a multifaceted approach to more accurately assess sleep disorders. This scale evaluates an individual's sleep according to various factors (e.g., sleep duration, time to fall asleep, and difficulty felt upon waking).
This scale, consisting of 24 questions, consists of 19 questions based on the individual's self-assessment and 5 questions answered by the spouse or roommate. Such a structure evaluates the individual's sleep quality from a broader perspective, taking into account the effects of possible . A high score indicates increased violence, which is a negative situation.
Measured: 8 week
Body Composition
Measurement was made with Tanita body analysis scale. (TANITA TT 730 MA)
The height and weight of the patients were measured by the same person with standardized devices. Body mass index (BMI) is obtained by dividing the body weight measured in kilograms by the square of the height in meters. This method is a practical classification tool widely used to determine whether the individual is underweight, normal weight, overweight or obese. Waist circumference measurement was made with a tape measure at the level of the navel, with the individuals in an upright position and the abdomen relaxed. During the measurement, the tape measure was used in a way that it would touch the skin without applying pressure.
Measured: 8 week
BLOOD LIPID PROFILE
During routine doctor visits, patients' blood values are routinely checked by the hospital's specialist doctor. The blood values already taken/taken will be used.
Total cholesterol (TC)
High-density lipoprotein (HDL)
Low-density lipoprotein (LDL)
Triglyceride (TG)
Measured: 8 week
AEROBIC CAPACITY
The Six Minute Walk Test (6MWT) is a practical, reliable and widely used measurement method for evaluating an individual's cardiopulmonary functions and general physical endurance level. This test is widely used especially in the evaluation of disorders in the respiratory or cardiovascular systems. The purpose of the test is to observe the individual's performance during physical exercise, to evaluate the level of fatigue and to determine the level of endurance. The use of the Modified Borg Scale in the assessment of dyspnea increases the reliability and validity of the test. The Borg scale is a common tool for measuring the severity of dyspnea and allows the patient to express their symptoms numerically. The 0-10 rating scale is a practical measurement tool that allows the patient to subjectively assess the severity of dyspnea they experience. In this system, "0" represents no dyspnea, while "10" represents the most severe and intolerable dyspnea.
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 posted30 May 2025
- Study start5 Sep 2023
- Primary completion15 Mar 2024
- Study completion20 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopausalStudies 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. Mat pilates group 3. Lifestyle change group
- Masking
- None (open label)
- Enrolment
- 45 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
- Merve YİĞİT KOCAMER MERVE, Principal investigator, Batman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06996743
- Sponsor's protocol ID
- BU-FTR-MYK-01
- Status last verified
- May 2025
- First submitted
- 7 May 2025
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pilates Exercises on Menopausal Symptoms in Postmenopausal Obesity
- ClinicalTrials.gov ID
- NCT06996743
- Acronym / sponsor ID
- BU-FTR-MYK-01
- Keywords
- menopause, obese women, pilates exercises, blood lipid profile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Batman UniversityUniversity, hospital or other
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 20 Mar 2025 (actual)
- First posted
- 30 May 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, a significant transition in a woman's life characterized by the cessation of menstruation and a decline in ovarian function, leads to reduced levels of estrogen and progesterone. This hormonal shift is associated with a range of symptoms that can adversely affect women's quality of life, including vasomotor symptoms such as hot flashes and night sweats, psychological symptoms like mood swings and depression, as well as urogenital symptoms such as vaginal dryness and sexual dysfunction. These symptoms, collectively referred to as menopausal symptoms, can vary in severity and duration and frequently require intervention to alleviate their impact on daily life.
Detailed description
The aim of our study was to determine the effect of pilates exercises on menopausal symptoms in postmenopausal obesity and to compare it with the control group. The study was designed as a single-blind randomized controlled trial. 45 obese individuals in the postmenopausal period were included in the study. The patients were randomly divided into 3 groups and a total of 16 treatment sessions were applied to both groups for 8 weeks, 2 days a week. No exercise intervention was applied to the control group. Reformer Pilates exercises were applied to Group 1, and mat Pilates exercises were applied to Group 2. A physical activity-based brochure including lifestyle changes was distributed to Group 3. A total of two evaluations were made before and after exercise. In the evaluation, the Menopausal Symptoms RatingScale (MRS) for menopausal symptoms, the Menopause-Specific Quality of Life Assessment Scale (MENQOL) for quality of life assessment, the Beck Depression Inventory (BDI) for depression, the Pittsburgh Sleep Quality Index (PSQI) for assessing sleep quality, the Six-Minute Walking Test (6 MWT) for assessing aerobic capacity, the Body Analysis Scale (TANITA) for assessing body composition, and laboratory analyses of blood samples taken for assessing blood lipid profile were used. Statistical analyses were performed to compare the data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 1. Reformer pilates group 2. Mat pilates group 3. Lifestyle change group
| Arm | Type | Receives |
|---|---|---|
| reformer pilates group | Active comparator | Other: reformer pilates groupIt was done by a specialist physiotherapist on a Pilates reformer device, and the exercises lasted approximately 60 minutes. The exercise content consists of strengthening exercises, stretching exercises, and warm-up and cool-down exercises. The program was updated with the addition of a new exercise type every two weeks. The repetition numbers were updated to 8 repetitions in the first two weeks, 10 repetitions in the third and fourth weeks, and 12 repetitions in the last four weeks. |
| 2- Mat pilates group | Active comparator | Other: Mat pilates groupThe special exercises in the reformer pilates program were applied as structured mat pilates. First, the exercises to be done by the physiotherapist were taught. Then, an illustrated brochure with the exercises was prepared by the expert physiotherapist and distributed to the participants in this group. In order for the exercise to be done correctly and effectively, a video shot by the expert physiotherapist was sent to the patients in addition to the brochure. Each exercise was explained in detail in the video and the tricks were mentioned. The patient did the exercises at home. Online control was provided via smartphone once a week and the exercises were done under the observation of the expert physiotherapist during the online interview. The exercise follow-up chart was filled out regularly twice every week. The exercise duration lasted approximately 60 minutes. The program was updated with the addition of a new exercise type every two weeks and continued in its fixed form for the |
| 3- Lifestyle change group | Active comparator | Other: Lifestyle change groupAfter the doctor's check-up, routine application continued. The patient was informed about physical activity. In addition; a physical activity-based brochure prepared by the Specialist Physiotherapist was distributed to the participants in this group. The brochure included methods for coping with menopause and lifestyle changes to reduce symptoms. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women who have entered menopause
- Being diagnosed with obesity (30 kg/m2 ≤ BMI ≤ 40 kg/m2 )
- Having the physical or cognitive ability to exercise
- Being sedentary ('International Physical Activity Questionnaire' will be used. Those in the Inactive Category group will be included.)
- Those who agree to participate in the study
Key exclusion criteria (7 listed)
- BMI below 30
- Those with serious heart disease, DM, kidney, liver, thyroid disease and cancer
- Those receiving hormone therapy
- Those using antipsychotic drugs
- Those using steroids and derivatives
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 |
|---|---|---|
| reformer pilates groupReformer Pilates exercises were applied to the pilates group twice a week for a total of 8 weeks. | Other | reformer pilates group |
| Mat pilates groupMat Pilates exercises were applied to the pilates group twice a week for a total of 8 weeks. | Other | 2- Mat pilates group |
| Lifestyle change groupAfter the doctor's check-up, routine application continued. The patient was informed about physical activity. In addition; a physical activity-based brochure prepared by the Specialist Physiotherapist was distributed to the participants in this group. | Other | 3- Lifestyle change group |
Primary outcome
Menopause Symptoms Assessment Scale (MSAS)
Time frame: 8 week
The Menopause Symptoms Assessment Scale (MSS) is a very useful tool for assessing the symptoms of women in menopause and measuring their impact on their quality of life. Using a Likert-type scale, determining the severity of symptoms provides important data for treatment and intervention planning. In particular, being organized in 3 sub-dimensions (somatic, psychological and urogenital complaints) helps understand the different aspects of menopause. This diversity provides a comprehensive assessment for both health professionals and researchers. The Likert-type scale, which includes menopausal complaints, is scored between 0 and 4. It indicates that the complaint is not present at all, while 4 indicates that it is very severe. The total score of the scale is calculated with the scores obtained from each item.high score indicates negativity
Menopause-Specific Quality of Life Scale (MSQLS)
Time frame: 8 week
The Menopause-Specific Quality of Life Scale (MSQLS) is a comprehensive tool that multi-dimensionally assesses the quality of life of women in the menopausal process. Developed by Hilditch and colleagues, this scale focuses on the physical, psychosocial, sexual and vasomotor symptoms of menopause, revealing the impact of different symptoms on quality of life in more detail. Especially the Likert-type assessment consisting of 32 questions and scored from 1 to 8 is very useful in examining the severity of problems in the menopausal process. Such a scale is an important tool for understanding the difficulties experienced by women in the menopausal period and for making appropriate interventions. The scoring of each subdomain helps determine the degree to which problems specific to that subject cause discomfort, which allows for more effective development of treatment and support plans. The lowest score is 8 and the highest score is 256. High score indicates negativity
5 secondary outcomes
Beck Depression Inventory
Time frame: 8 week
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 8 week
Body Composition
Time frame: 8 week
BLOOD LIPID PROFILE
Time frame: 8 week
AEROBIC CAPACITY
Time frame: 8 week
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 30 May 2025.
- 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.
Merve YİĞİT KOCAMER MERVE principal investigator
Batman University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reformer pilates group, Mat pilates group and Lifestyle change group in people with Menopausal and Obese Patients, run by Batman University at 2 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 5 inclusion and 7 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 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 Symptoms Assessment Scale (MSAS) (time frame: 8 week). The study lists 2 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 30 May 2025.