Clinical trial NCT06835062: Clinical Pilates' Impact on Fitness, Symptoms & Kinesiophobia in PMS
Official title: The Effects of Clinical Pilates on Physical Fitness Parameters, Symptom Severity, and Kinesiophobia in Women With Premenstrual Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premenstrual Syndrome
Pilates Exercise
Keywords: Premenstrual Syndrome
Physical Fitness
Kinesiophobia
Clinic Pilates
Lead sponsor: Atlas University
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Premenstrual syndrome (PMS) is characterized by a series of somatic and psychological symptoms of varying severity that occur during the luteal phase of the menstrual cycle, affecting approximately 30% of women and resolving with menstruation. These symptoms impact daily activities, interpersonal relationships, social engagements, work efficiency, and educational productivity. PMS manifests with physical symptoms such as breast swelling and tenderness, fatigue, headaches, and weight gain, as well as psychological and emotional symptoms such as mood disorders, irritability, and stress. Symptoms typically subside with the onset of menstruation. There is no single accepted treatment for PMS. Due to conflicting findings in studies, various treatment methods are used, including lifestyle modifications, education, stress management techniques (such as massage, reflexology, and yoga), exercise, or medical support. Regular exercise is known to improve overall well-being. It prevents the decrease in endorphin secretion during the luteal phase of the menstrual cycle and has a positive impact on PMS symptoms, particularly mood disorders, fluid retention, and breast tenderness. Pilates-based exercise training is an approach that enhances muscle stability through effective, controlled movements while strengthening muscle groups associated with pain. Clinical Pilates-based exercise training is considered a preferable method for PMS management, as it is believed to improve functional capacity, pain management, mood disorders, endurance, flexibility, symptom severity, and fear of movement in individuals with PMS. Due to the limited number of studies in the literature on PMS, our study aims to investigate the effects of a clinical Pilates-based exercise program on functional fitness parameters, symptom severity, and kinesiophobia.


Eligibility criteria: Inclusion Criteria:

* Having Premenstrual Syndrome (PMS)
* Being able to read and understand Turkish
* Willingness to participate in the study

Exclusion Criteria:

* Being in menopause or perimenopause
* Being pregnant
* Currently participating in or having engaged in a regular exercise program (other than clinical Pilates) within the past year
* Having comorbid orthopedic, musculoskeletal, psychological, or cardiovascular conditions that may affect test evaluations

Primary outcomes:
measure: Body Composition (Waist Circumference)
timeFrame: 8 weeks
measure: Body Composition (Hip Circumference)
timeFrame: 8 weeks
measure: Body Composition (Waist-to-Hip Ratio)
timeFrame: 8 weeks
measure: Functional Capacity
timeFrame: 8 weeks
measure: Flexibility
timeFrame: 8 weeks
measure: Endurance (Trunk Flexion Test)
timeFrame: 8 weeks
measure: Endurance (Lateral Bridge Test)
timeFrame: 8 weeks
measure: Endurance (Modified Biering-Sorensen Test)
timeFrame: 8 weeks
measure: Endurance (Prone Bridge Test)
timeFrame: 8 weeks
measure: Premenstrual Syndrome Scale
timeFrame: 8 weeks
measure: Tampa Scale for Kinesiophobia
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Atlas University
city: Istanbul
country: Turkey
facility: Istanbul Atlas University
Study officials:
affiliation: Atlas University
name: Meltem Kaya
role: PRINCIPAL_INVESTIGATOR
References: