Clinical trial NCT06996743: Effect of Pilates Exercises on Menopausal Symptoms
Official title: Effect of Pilates Exercises on Menopausal Symptoms in Postmenopausal Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopausal
Obese Patients
Pilates Exercise
Quality of Life and Menopause
Keywords: menopause
obese women
pilates exercises
blood lipid profile
Lead sponsor: Batman University
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 45
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. Reformer pilates group
2. Mat pilates group
3. Lifestyle change group
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Menopause Symptoms Assessment Scale (MSAS)
timeFrame: 8 week
measure: Menopause-Specific Quality of Life Scale (MSQLS)
timeFrame: 8 week
Secondary outcomes:
measure: Beck Depression Inventory
timeFrame: 8 week
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 8 week
measure: Body Composition
timeFrame: 8 week
measure: BLOOD LIPID PROFILE
timeFrame: 8 week
measure: AEROBIC CAPACITY
timeFrame: 8 week
Other outcomes:
Locations:
city: Batman
country: Turkey
facility: Batman Center
state: Gültepe
city: Batman
country: Turkey
facility: Batman
Study officials:
affiliation: Batman University
name: Merve YİĞİT KOCAMER MERVE
role: PRINCIPAL_INVESTIGATOR
References: