The Effect of PVE Applied in Addition to Pilates on Premenstrual Symptoms, Pain, Sleep and QoL in Individuals With PMS

NCT ID: NCT06191536

Last Updated: 2024-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-01
• Study Completion Date: 2024-07-20

Brief Summary

Premenstrual syndrome (PMS) is a condition that occurs with physical and psychological symptoms in the late luteal phase of the menstrual cycle in women and affects the physical and mental well-being of the individual. Physiological symptoms; edema, headache, fatigue, weight gain and breast swelling and tenderness, and psychological symptoms; It can be seen as tension, anger, depressed mood or stress. Although it usually ends with the onset of menstruation, its repetition with each menstrual cycle affects the individual's pain coping strategies, sleep and quality of life.

Different methods such as pharmacological agents, physiotherapy applications, nutrition and lifestyle adjustments, breathing exercises, stress management, meditation and cognitive behavioral therapy are used to cope with PMS, which appears with symptoms of different severities from individual to individual.

Detailed Description

Exercise; It is known to have positive physical and psychological effects on PMS symptoms by reducing muscle cramps, increasing circulation and controlling the neuromuscular system. Pilates, as an exercise method that combines body-mind conditioning with breathing control and focuses on lumbopelvic stability and targets core stabilization, is also thought to have a significant effect on increasing pelvic floor muscle strength by performing it together with pelvic floor muscle contraction. In addition, considering the anatomical connection of the pelvic floor muscles with other core muscles, it has been observed that pelvic floor muscle contractions also occur during abdominal muscle contraction. The pelvic floor consists of a group of muscles and connective tissues that extend like a sling across the pelvic floor; It consists of two layers, the superficial perineal muscles and the deep pelvic diaphragm, and provides support to the pelvic organs, bladder and elements of the spine. Pelvic floor exercises are a safe and effective means of decreasing the symptoms and signs of pelvic disorders. In the literature, it is seen that these exercises are effective in urinary incontinence.

There is no study examining the effect of pelvic floor muscle training combined with pilates on PMS symptoms. The purpose of this study; To examine the effects of pelvic floor exercises, in addition to pilates exercises, on PMS symptoms, pain, sleep and quality of life in individuals with premenstrual syndrome.

Conditions

Premenstrual Syndrome; Pelvic Floor Disorders; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pilates Group (PG)

Pilates exercises will be performed under the supervision of a certified pilates instructor.

Pilates exercises will be performed for 50 minutes, 2 days a week for 8 weeks.

Group Type: EXPERIMENTAL

Pilates

Intervention Type: OTHER

Pelvic Floor Exercise Group (PFEG)

It consists of voluntary pelvic floor muscle contractions applied in addition to pilates exercises.

Pelvic floor muscle contractions involve maximum contraction of the pelvic floor muscles alternately for five repetitions during exhalation.

Pelvic floor exercises will be applied under the supervision of a pelvic floor certified physiotherapist.

In addition to pilates exercises, pelvic floor exercises will be applied 2 days a week, 50 minutes, for 8 weeks.

Group Type: ACTIVE_COMPARATOR

Pilates

Intervention Type: OTHER

Pelvic floor exercises

Intervention Type: OTHER

Interventions

Pilates

Intervention Type: OTHER

Pelvic floor exercises

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Be willing to participate in research
• Getting a score of 111 or higher on the PMS Scale,
• Experiencing premenstrual symptoms for at least 3 months,
• Having a pain score of at least 4 on the Visual Analogue Scale during any menstrual period within the last 3 months.
• Regular menstrual cycle for 12 months (24-35 days),

Exclusion Criteria

• Being under 18 years of age,
• Change in menstrual characteristics after PMS diagnosis,
• Having a chronic or physical illness that prevents you from doing Pilates.
• People who have had surgery in the last 6 months,
• Individuals with musculoskeletal system problems,
• Individuals with chronic diseases,
• People receiving hormone therapy,
• Pregnant individuals,
• People with urinary, genital or gastrointestinal disorders,
• People who have had hysterectomy surgery.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Uskudar University

OTHER

Sponsor Role: lead

Responsible Party

osman coban

Asst. Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

osman coban, PhD

Role: PRINCIPAL_INVESTIGATOR

Uskudar University

Locations

Heracity Pilates

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Culligan PJ, Scherer J, Dyer K, Priestley JL, Guingon-White G, Delvecchio D, Vangeli M. A randomized clinical trial comparing pelvic floor muscle training to a Pilates exercise program for improving pelvic muscle strength. Int Urogynecol J. 2010 Apr;21(4):401-8. doi: 10.1007/s00192-009-1046-z. Epub 2010 Jan 22.

Reference Type: BACKGROUND

PMID: 20094704 (View on PubMed)

Leite A, Matignon A, Marlot L, Coelho A, Lopes S, Brochado G. The Impact of Clinical Pilates Exercises on Tension-Type Headaches: A Case Series. Behav Sci (Basel). 2023 Jan 27;13(2):105. doi: 10.3390/bs13020105.

Reference Type: BACKGROUND

PMID: 36829334 (View on PubMed)

Yaray O, Akesen B, Ocaklioglu G, Aydinli U. Validation of the Turkish version of the visual analog scale spine score in patients with spinal fractures. Acta Orthop Traumatol Turc. 2011;45(5):353-8. doi: 10.3944/AOTT.2011.2528.

Reference Type: BACKGROUND

PMID: 22033000 (View on PubMed)

Soylu C, Kutuk B. Reliability and Validity of the Turkish Version of SF-12 Health Survey. Turk Psikiyatri Derg. 2022 Summer;33(2):108-117. doi: 10.5080/u25700. English, Turkish.

Reference Type: BACKGROUND

PMID: 35730511 (View on PubMed)

Other Identifiers

UskudarUniversitesi

Identifier Type: -

Identifier Source: org_study_id