- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06996743
- Original Trial
Effect of Pilates Exercises on Menopausal Symptoms
Effect of Pilates Exercises on Menopausal Symptoms in Postmenopausal Obesity
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Batman, Turkey
- Batman
-
-
Gültepe
-
Batman, Gültepe, Turkey, 72000
- Batman Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
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 |
|---|---|
|
Active Comparator: reformer pilates group
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. |
Reformer Pilates exercises were applied to the pilates group twice a week for a total of 8 weeks.
|
|
Active Comparator: 2- Mat pilates group
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
|
Mat Pilates exercises were applied to the pilates group twice a week for a total of 8 weeks.
|
|
Active Comparator: 3- Lifestyle change group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 |
8 week
|
|
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 |
8 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Beck Depression Inventory
Time Frame: 8 week
|
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. |
8 week
|
|
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 8 week
|
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. |
8 week
|
|
Body Composition
Time Frame: 8 week
|
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. |
8 week
|
|
BLOOD LIPID PROFILE
Time Frame: 8 week
|
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) |
8 week
|
|
AEROBIC CAPACITY
Time Frame: 8 week
|
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.
|
8 week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Merve YİĞİT KOCAMER MERVE, Batman University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- BU-FTR-MYK-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Menopausal
-
University of Wisconsin, MadisonNot yet recruiting
-
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training...Not yet recruitingMenopausal Women | Hormone Therapy | Menopausal Symptom Relief | Menopausal Hormone TherapyTurkey (Türkiye)
-
Angelica Lindén HirschbergRecruiting
-
Olly, PBCCompletedRandomized Placebo Controlled Clinical Study of an Oral Product in Subjects With Menopausal SymptomsMenopausal SymptomsUnited States
-
Eetho Brands, IncNot yet recruitingMenopausal Symptoms
-
Marmara University Pendik Training and Research...CompletedMenopausal ComplaintsTurkey
-
University of ReadingCompletedPost MenopausalUnited Kingdom
-
Taipei City HospitalNational Taiwan University HospitalUnknownMenopausal WomenTaiwan
-
Graminex LLCKGK Science Inc.Recruiting
-
Mersin UniversityCompleted
Clinical Trials on reformer pilates group
-
Istanbul Medipol University HospitalCompleted
-
Sahmyook UniversityCompletedLow Back PainKorea, Republic of
-
Uskudar UniversityCompletedOccupational DiseasesTurkey (Türkiye)
-
Gazi UniversityCompleted
-
Uskudar UniversityCompletedLow Back Pain | Kinesiophobia | Disc HerniationTurkey (Türkiye)
-
Osmaniye Korkut Ata UniversityCompletedSports, MechanicalTurkey
-
Istanbul Medipol University HospitalCompleted
-
Uskudar UniversityRecruitingLow Back PainTurkey (Türkiye)
-
Istanbul Medipol University HospitalCompleted
-
Trakya UniversityRecruiting