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Enrolling by invitation Observational

The Effect of Physical Activity Levels on Dysmenorrhea Severity, Menstrual Symptoms, and Functional and Emotional Status in Women Diagnosed With Multiple Sclerosis

NCT07011875 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2025-06-02
Last updated
2025-06-10

Condition(s) studied

Multiple SclerosisPhysical ActivityDysmenorrheaEmotional Disorder

Study summary

Multiple sclerosis (MS) is a chronic, inflammatory, autoimmune disease that affects the central nervous system. It is more common in women, and hormonal factors are believed to play a role in its progression. The relapsing-remitting form of MS is particularly prevalent among women, leading to fluctuations in symptoms throughout the menstrual cycle.

One of the symptoms experienced during menstruation is dysmenorrhea, which can significantly impact quality of life due to severe pain and functional limitations. Dysmenorrhea is associated with both emotional and physical symptoms, and in women with MS, neurological symptoms may further intensify menstrual discomfort.

Physical activity is known to reduce inflammation and improve overall health. It has been shown to positively affect both MS symptoms and menstrual symptoms, including dysmenorrhea. However, research specifically examining the effects of physical activity on dysmenorrhea severity, menstrual symptoms, and emotional well-being in women with MS is limited.

This study aims to evaluate the impact of physical activity levels on dysmenorrhea severity, menstrual symptoms, and emotional well-being in women diagnosed with MS, addressing a gap in the literature and contributing to clinical practice.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
55 Years
Healthy volunteers
No
Inclusion Criteria: * Female patients diagnosed with multiple sclerosis by a neurologist Aged between 18 and 55 years Having an active menstrual cycle Having a regular menstrual cycle (24-35 days) No physical or cognitive impairment that prevents participation in exercise Willingness to participate in the study Exclusion Criteria: * Postmenopausal status Pregnancy or breastfeeding Use of hormonal contraceptives or intrauterine devices Use of medication that may affect dysmenorrhea History of any gynecological surgery Presence of pelvic pathology, pelvic inflammatory disease, endometriosis, or other conditions causing secondary dysmenorrhea

Primary outcome measure(s)

  • Numerical Rating Scale — Baseline
    Participants will rate the intensity of menstrual pain using the Numerical Rating Scale from 0 (no pain) to 10 (worst pain imaginable). Only whole numbers will be used.
  • Functional and Emotional Impact of Dysmenorrhea — baseline
    This 14-item Likert-type scale evaluates the functional and emotional impact of dysmenorrhea. Each item is scored from 1 to 5. Higher scores indicate greater functional and emotional impairment.
  • International Physical Activity Questionnaire - Short Form — baseline
    Participants' physical activity levels during the last 7 days will be assessed using the IPAQ-Short Form. Results will be calculated in MET-minutes/week and categorized into three levels: inactive (\<600 MET-min/week), low (600-3000 MET-min/week), and sufficient (\>3000 MET-min/week).
  • Patient Determined Disease Steps — baseline
    Functional disability related to multiple sclerosis will be assessed using the PDDS, a patient-reported outcome scale ranging from 0 (normal) to 8 (bedridden). Higher scores indicate more severe disability.
  • Menstrual Symptom Questionnaire — baseline
    The Menstrual Symptom Questionnaire, consisting of 22 items rated on a 5-point Likert scale, will be used to assess somatic, emotional, and coping symptoms experienced during menstruation. Total scores range from 22 to 110, with higher scores indicating more severe symptoms.

Trial sites (1)

FacilityCityRegionStatus
Karabuk University Karabük Karabük Province
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07011875 on ClinicalTrials.gov ↗ ← All trials in Turkey