ClinicalTrials.gg
Enrolling by invitationNCT07011875Updated Jun 10, 2025

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

An observational study in Multiple Sclerosis, Physical Activity and Dysmenorrhea, sponsored by Karabuk University. Enrolling by invitation at 1 site in Turkey. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-06-10.

Sponsored by Karabuk University · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 3 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
60
Ages
18 Years to 55 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 307 studies in Multiple Sclerosis with a site in Turkey — 59 open to participants now, 78 under way, 10 of them phase 3. Multiple Sclerosis · Turkey.

Planned enrollment
48th of 103
60 · median 60
Started
2025
with 36 others
Observational
103 of 307
27 open now
Primary completion
2025-08
later than 23 of 77 live
Registered
233rd of 307
by date

Among the 307 studies in Multiple Sclerosis with a site in Turkey, this one is the 48th largest by planned enrollment of the 103 observational ones, is one of 37 that started in 2025, is one of 103 observational ones, reaches primary completion later than 23 of the 77 other live ones, and was the 233rd registered.

By phase

307 studies; the count open now beside each. This study's row is marked.

No phase155 · 31 open
Observationalthis study103 · 27 open
Phase 340 · 1 open
Phase 26 · 0 open
Phase 43 · 0 open

By the year they started

First in 2004; this study’s year is marked. 37 started in 2025.

Size and results

Median enrollment 40 across the 204 interventional studies, 60 across the 103 observational. Of the 204 that completed or were terminated, 37 (18%) have results posted.

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02

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.

Read the detailed description

Multiple sclerosis (MS) is a chronic, inflammatory, autoimmune, and demyelinating disease that causes damage to the white matter of the central nervous system. It is typically seen between the ages of 20 and 40. The incidence of MS is reported to be three times higher in women than in men. Although its etiology is not definitively known, it is thought that a combination of genetic predisposition and a non-genetic trigger-such as a virus, metabolism, or environmental factors-leads to recurring immune attacks on the central nervous system, resulting in a self-sustaining autoimmune disorder.

These factors, along with hormonal influences, contribute to the gender-related differences observed in MS. The main types of MS include relapsing-remitting, secondary progressive, primary progressive, and progressive-relapsing. The relapsing-remitting form is more common in women and is characterized by an earlier onset, more inflammatory lesions, and more frequent attacks. The higher prevalence of MS in women highlights the impact of hormonal factors on disease progression. Hormonal fluctuations throughout the menstrual cycle can cause variations in symptoms among women with MS. Some women with MS experience worsening symptoms before menstruation.

This worsening is most frequently reported in women with relapsing-remitting MS and is likely due to both new demyelinating plaques (exacerbation) and temporary symptom increases associated with previous plaques (pseudo-exacerbation). While the effects of hormonal fluctuations on MS are known, the overall impact of menstrual cycles on health should not be overlooked. The menstrual period is characterized by symptoms such as dysmenorrhea, which can negatively affect women's quality of life.

Dysmenorrhea is categorized into primary and secondary types. Primary dysmenorrhea is the most common form and is characterized by menstrual pain occurring before or during menstruation without any underlying pelvic disease. It typically begins 1-2 years after menarche or within 6-12 months and can persist until the age of 40. Dysmenorrhea is not limited to pain; it is also associated with emotional and physical symptoms such as irritability, depression, sleep disturbances, fatigue, decreased work performance, and functional limitations.

In women with MS, increased hormonal fluctuations may exacerbate existing neurological symptoms and intensify menstrual symptoms. This suggests that dysmenorrhea management in women with MS should be specifically evaluated. Physical activity is defined as any repetitive movement generated by skeletal muscles that results in an increased metabolic response compared to resting levels. Various studies have shown that regular physical activity is effective in reducing inflammation, supporting pain management, and improving psychological well-being.

In individuals with MS, the long-term immunomodulatory effects of physical activity are well known. Exercise has been shown to reduce inflammation and partially regulate neuroimmune parameters related to T-cell behavior. Similarly, physical activity has been reported to have a positive effect on menstrual symptoms such as dysmenorrhea. However, no studies have specifically investigated the impact of physical activity on dysmenorrhea severity, menstrual symptoms, and emotional status in women with MS.

Existing literature provides valuable insights into how physical activity affects disease symptoms in women with MS, but studies focusing on dysmenorrhea and menstrual symptoms are lacking. This study aims to fill this gap in the literature and contribute to clinical practice by evaluating the effects of physical activity levels on dysmenorrhea severity, menstrual symptoms, and functional and emotional status in women diagnosed with MS.

03

Conditions studied

  • Multiple Sclerosis
  • Physical Activity
  • Dysmenorrhea
  • Emotional Disorder

Keywords

  • Multiple Sclerosis
  • Physical Activity Level
  • Dysmenorrhea Severity
  • Menstrual Symptom
  • Functional and Emotional Status
04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • status

Pregnancy or breastfeeding

Use of hormonal 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

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • Women diagnosed with multiple sclerosis

    Women diagnosed with multiple sclerosis by a neurologist

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: baseline

  3. 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).

    Time frame: baseline

  4. 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.

    Time frame: baseline

  5. 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.

    Time frame: baseline

07

Study locations

1 site
08

References and documents

Publications

  • 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. PubMed 30266889 ↗
  • 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. PubMed 31541863 ↗
  • 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. PubMed 23858327 ↗
  • 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. PubMed 33970361 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2025 (actual). Primary completion is estimated for Aug 2025, 2 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 2, 2025
First posted
Jun 10, 2025
StartActual
Jun 2, 2025
Primary completionEst.
Aug 2025
CompletionEst.
Sep 2025
Last update
Jun 10, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07011875
Lead sponsor
Karabuk University
Responsible party
METEHAN YANA (Assistant Professor, Karabuk University) — Principal investigator
First posted
Jun 10, 2025
Start date
Jun 2, 2025
Primary completion
Aug 2025 (estimated)
Completion
Sep 2025 (estimated)
Last update
Jun 10, 2025

Study contacts

Metehan YANA
principal investigator · Karabuk University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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