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

NCT07011875 | Enrolling By Invitation

• 1 other identifier: Multiple Sclerosis in Women
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis; Physical Activity; Dysmenorrhea; Emotional Disorder

Keywords

Multiple Sclerosis; Physical Activity Level; Dysmenorrhea Severity; Menstrual Symptom; Functional and Emotional Status

Outcome Measures

Primary Outcomes (5)

• Numerical Rating Scale

  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.

  Baseline

• Functional and Emotional Impact of Dysmenorrhea

  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.

  baseline

• International Physical Activity Questionnaire - Short Form

  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).

  baseline

• Patient Determined Disease Steps

  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.

  baseline

• Menstrual Symptom Questionnaire

  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.

  baseline

Study Arms (1)

Women diagnosed with multiple sclerosis

Women diagnosed with multiple sclerosis by a neurologist

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study will include women with multiple sclerosis recruited from a patient association, focusing on those with active menstrual cycles to explore the relationship between physical activity and menstrual-related symptoms.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karabuk University: lead

Study Sites (1)

Karabuk University

Karabük, Karabük Province, 78000, Turkey (Türkiye)

Location

Related Publications (4)

• Houtchens MK, Edwards NC, Schneider G, Stern K, Phillips AL. Pregnancy rates and outcomes in women with and without MS in the United States. Neurology. 2018 Oct 23;91(17):e1559-e1569. doi: 10.1212/WNL.0000000000006384. Epub 2018 Sep 28.

  PMID: 30266889 BACKGROUND

• Guven Yorgun Y, Ozakbas S. Effect of hormonal changes on the neurological status in the menstrual cycle of patient with multiple sclerosis. Clin Neurol Neurosurg. 2019 Nov;186:105499. doi: 10.1016/j.clineuro.2019.105499. Epub 2019 Sep 10.

  PMID: 31541863 BACKGROUND

• Harbo HF, Gold R, Tintore M. Sex and gender issues in multiple sclerosis. Ther Adv Neurol Disord. 2013 Jul;6(4):237-48. doi: 10.1177/1756285613488434.

  PMID: 23858327 BACKGROUND

• Roeder HJ, Leira EC. Effects of the Menstrual Cycle on Neurological Disorders. Curr Neurol Neurosci Rep. 2021 May 10;21(7):34. doi: 10.1007/s11910-021-01115-0.

  PMID: 33970361 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity; Dysmenorrhea

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior; Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Metehan YANA

  Karabuk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 10, 2025
• Study Start: June 2, 2025
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: June 10, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)