NCT06996743

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 5, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 30, 2025

Completed
Last Updated

May 30, 2025

Status Verified

May 1, 2025

Enrollment Period

6 months

First QC Date

May 7, 2025

Last Update Submit

May 21, 2025

Conditions

Keywords

menopauseobese womenpilates exercisesblood lipid profile

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    8 week

Secondary Outcomes (5)

  • Beck Depression Inventory

    8 week

  • Pittsburgh Sleep Quality Index (PSQI)

    8 week

  • Body Composition

    8 week

  • BLOOD LIPID PROFILE

    8 week

  • AEROBIC CAPACITY

    8 week

Study Arms (3)

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.

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

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.

Other: Lifestyle change group

Interventions

Reformer Pilates exercises were applied to the pilates group twice a week for a total of 8 weeks.

reformer pilates group

Mat Pilates exercises were applied to the pilates group twice a week for a total of 8 weeks.

2- Mat pilates 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.

3- Lifestyle change group

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFEMALE
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Batman Center

Batman, Gültepe, 72000, Turkey (Türkiye)

Location

Batman

Batman, Turkey (Türkiye)

Location

Study Officials

  • Merve YİĞİT KOCAMER MERVE

    Batman University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 1. Reformer pilates group 2. Mat pilates group 3. Lifestyle change group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

May 7, 2025

First Posted

May 30, 2025

Study Start

September 5, 2023

Primary Completion

March 15, 2024

Study Completion

March 20, 2025

Last Updated

May 30, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations