Investigation of the Effects of Pilates Exercises on Menopause Symptoms and Sexual Dysfunction in Postmenopausal Women

NCT06837714 | Completed

• 1 other identifier: BAU-FTR-MYK-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief 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 as vaginal dryness and sexual dysfunction.

Conditions

Menopausal Syndrome; Sexual Dysfunctions; Quality of Life and Menopause

Keywords

postmenopause; pilates; menopausal syndrome; sexual dysfunctions; Quality of life

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  8 week

Study Arms (2)

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

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.

Other: Behavioral: lifestyle changes

Interventions

PİLATES GROUP OTHER

A total of 16 sessions were applied for 8 weeks, 2 sessions per week.

pilates group

Behavioral: lifestyle changes OTHER

presentation including lifestyle changes was prepared and training was provided.

group that includes lifestyle changes

Eligibility Criteria

• Age: 45 Years - 60 Years
• Gender Eligibility Details: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women who have reached menopause
• Being physically or cognitively competent to exercise
• Those who agreed to participate in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Batman University: lead

Study Sites (3)

Batman Center

Batman, Gültepe, 72000, Turkey (Türkiye)

Location

Batman university

Batman, 72000, Turkey (Türkiye)

Location

Türkiye

Batman, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 40489883 DERIVED

Study Officials

• YİĞİT KOCAMER MERVE

  Batman University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: 1. Reformer pilates group 2. Group that includes lifestyle changes

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: February 20, 2025
• Study Start: September 15, 2023
• Primary Completion: March 5, 2024
• Study Completion: October 10, 2024
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (3)