Multiple SclerosisNCT07011875
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 of Multiple Sclerosis and Physical Activity, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Multiple Sclerosis, Physical Activity, Dysmenorrhea
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jun 2025to Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Karabuk University
Karabük, Karabük Province, 78000
About this study
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.
Read more
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.
- Keywords
- Multiple Sclerosis, Physical Activity Level, Dysmenorrhea Severity, Menstrual Symptom, Functional and Emotional Status
- Medical subject headings
- Multiple Sclerosis, Motor Activity, Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women diagnosed with multiple sclerosis | Women diagnosed with multiple sclerosis by a neurologist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start2 Jun 2025
- Primary completionAug 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, METEHAN YANA, Karabuk University
- Investigators
- Metehan YANA, Principal investigator, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011875
- Sponsor's protocol ID
- Multiple Sclerosis in Women
- Status last verified
- May 2025
- First submitted
- 2 Jun 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 30266889Guven 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 31541863Harbo 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 23858327Roeder 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Physical Activity Levels on Dysmenorrhea Severity, Menstrual Symptoms, and Functional and Emotional Status in Women Diagnosed With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07011875
- Acronym / sponsor ID
- Multiple Sclerosis in Women
- Keywords
- Multiple Sclerosis, Physical Activity Level, Dysmenorrhea Severity, Menstrual Symptom, Functional and Emotional Status
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women diagnosed with multiple sclerosis | – | –Women diagnosed with multiple sclerosis by a neurologist |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- Postmenopausal status
- Pregnancy or breastfeeding
- Use of hormonal contraceptives or intrauterine devices
- Use of medication that may affect dysmenorrhea
- History of any gynecological surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Numerical Rating Scale
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Background: PubMed 30266889Houtchens 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.
- Background: PubMed 31541863Guven 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.
- Background: PubMed 23858327Harbo 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.
- Background: PubMed 33970361Roeder 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Metehan YANA principal investigator
Karabuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Physical Activity, run by Karabuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07011875, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.