Dysmenorrhea PrimaryNCT07436507
Effects of a Combined Home-Based Exercise Program on Menstrual Pain, Dual-Task Gait Performance, and EEG Markers of Cognitive-Motor Control in Females With Primary Dysmenorrhea
A study testing Home-exercise program in people with Dysmenorrhea Primary, run by University of Sharjah.
Trial summary
What is this study about? Dysmenorrhea, commonly known as painful period, is a common gynecological symptom experienced by several women of reproductive age. This particular type of pain arises during the menstrual cycle, often negatively impacting the quality of life and ability to successfully carry out daily… Read more about this study
- Who is it for?
- Ages 18 to 25 years, women only
- Conditions the study is for
- Dysmenorrhea Primary
- What is being tested?
- Home-exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- 6 Oct 2026to 31 May 2027
- Phase
- Interventional
- 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 25 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- single
- 18-25 years
- meet the diagnostic criteria for PD as outlined in the Primary Dysmenorrhea Consensus Guidelines - first onset of menstrual pain 6-24 months after menarche, pain lasting 8-72h in a cycle, and the most severe pain on the 1st or 2nd day of menstruation
- having a regular menstrual cycle (28 ± 7 days)
- menstrual pain intensity ≥4 cm on VAS in the previous 6 months
- absence of any known medical condition
Who cannot join
- history of pelvic surgery
- history and/or findings of secondary dysmenorrhea
- history of mental or physical diseases
- history of joint, motion, muscle, or bone diseases which reduce the abilities to exercise
- being a professional athlete
- taking analgesic or non-pharmacological agents other than NSAID for menstrual pain
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- used an intrauterine device or oral contraceptive pill
- metal implants, including pacemaker
- history of non-normal brain activity, including seizures
About this study
Official title: Effects of a Combined Home-Based Exercise Program on Menstrual Pain, Dual-Task Gait Performance, and Neurophysiological Outcomes in Primary Dysmenorrhoea: A Randomised Controlled Trial Protocol
What is this study about? Dysmenorrhea, commonly known as painful period, is a common gynecological symptom experienced by several women of reproductive age. This particular type of pain arises during the menstrual cycle, often negatively impacting the quality of life and ability to successfully carry out daily activities and academic or work performance. This is study will involve physiotherapy treatment in the form of a home-based exercise program for those experiencing dysmenorrhea. The purpose of this study is to determine how effective this exercise intervention is by assessing the pain score, menstrual symptoms, gait performance and cognitive-motor control.
Read the detailed description
What will the participant have to do if they take part? They will be asked to come to the University of Sharjah so the investigators can get some measurements. The participant will be asked to fill a form with the basic information about themselves, including as name, age, occupation, height, weight and contact details. They will also be asked about their menstrual pain score on VAS pain scale and to complete a questionnaire about their menstrual symptoms and lifestyle (such as physical activity, sleep, diet etc.). The physiotherapist will then give them a demonstration of the exercises they need to do during this 8-week program. The participant will be required to follow a video recording of the exercises to complete 3 sessions each week, for about 30 minutes. Necessary follow-up will take place each week. They will be given an exercise diary to keep track of when they do these sessions and for how long. On completion of all sessions after 8 weeks, the assessment previously done will be repeated.
What is the criteria for being selected? They study includes females, aged between 18 and 25, who experience dysmenorrhea.
Possible risks of taking part? There are no risks from this study. All the information will be confidential and when the study is finished, they will be destroyed.
Are there any possible benefits? There is expected benefit of the exercises on decreasing menstrual pain and symptoms.
Does the participant have to take part in this study? No. Participation is completely voluntary. If the participant does not wish to consent, they can refuse. If they wish to take part and then change their mind later, they can withdraw from the study any time.
Will the participant's taking part in this study be kept confidential? All the information taken from the participant will remain confidential and only the results will be used in the data analysis with the supervisor without using their name or address so they will not be recognised. At the end of the study, all personal information will be destroyed.
What will happen to the results of the research study? The participant will be notified about the study results once the study has been completed.
- Conditions
- Dysmenorrhea Primary
- Being tested
- Home-exercise program
- Keywords
- Dysmenorrhea Primary, Home exercise program, Dual-Task Gait Performance, Cognitive Motor Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-exercise programOther
The participants will then be given a clear explanation of the exercises to be performed as part of the home-based exercise program. They will be provided with a demonstrations video that will guide each session.
Each exercise session will last for 30 minutes, 3/week, for 8 weeks. Participants will perform 10 minutes of progressive muscle relaxation exercise, followed by 10 minutes of core exercises, and finally 10 mintes of stretching exercises. They will required to complete an exercise diary. Exercise progressions will be applied across weeks 3-4 and again at weeks 5-6 and 7-8 (e.g., increased hold durations, repetitions, and resistance band progression for core exercises).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Other: Home-exercise program |
| Control group | No intervention | Waitlist control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity is self-reported on the Visual Analogue Scale for Pain (VAS Pain), which is a continuous scale in the form of a 100mm line, marked by "no pain" (score of 0) on one end and "pain as bad as it could be" (score of 100) on the other end. The participant is required to make a perpendicular line on the VAS scale that they feel best represent their pain intensity. Change in the pain intensity at baseline and after 8 weeks of intervention will be noted.
Measured: Baseline and 8 weeks
Cortical Silent Period
Cortical silent period (CSP) will be assessed using the transcranial magnetic stimulation (TMS) apparatus. Single-pulse TMS will be administered using a figure-of-eight coil positioned over the primary motor cortex. CSP duration (ms) will be measured from the MEP onset to return of voluntary EMG activity following cortical stimulation. The minimal effective stimulation intensity will be used to ensure participant safety. Changes at baseline and after 8 weeks of intervention will be noted.
Measured: Baseline and 8 weeks
Secondary outcomes (5)
Dual-Task Gait Performance
Gait performance, including speed, cadence, stride length and double support time, will be assessed comparatively for single-task walking and dual-task walking (during cognitive tasks). Gwalk g-sensors equipment will be used for gait analysis. Changes in parameters as baseline and after 8 weeks intervention will be noted.
Measured: Baseline and 8 weeks
Dual-Task Cognitive Performance
Cognitive Performance on three tasks (logistic, semantic verbal fluency and working memory) will assessed during walking, at baseline and after 8 weeks intervention.
Measured: Baseline and 8 weeks
Electroencephalography (EEG) data
Brain activity for cognitive-motor control (Theta/alpha coherence) will be assessed during dual-walking task, using the NeXus-Q32 equipment. Changes in parameters at baseline and after 8 week intervention will be noted.
Measured: Baseline and 8 weeks
Dysmenorrhea impact
The Working Ability, Location, Intensity, Days of pain, and Dysmenorrhoea (WaLIDD) questionnaire will assess the impact of dysmenorrhoea on work and daily functioning. It measures the severity of dysmenorrhea by a total scoring range of 0 to 12 points, where a higher score indicates greater severity. Changes in total score at baseline and following 8 week intervention will be noted.
Measured: Baseline and 8 weeks
Menstrual Symptoms and Distress
Menstrual Distress Questionnaire (MEDI-Q) will be used to objectively assess the impact of menstrual pain, physical discomfort, emotional/cognitive changes, and gastrointestinal disturbances, as part of menstrual symptoms experienced in women with primary dysmenorrhea, at baseline and after 8 weeks intervention. The minimum score obtainable is "0", indicating the absence of any specified symptom relevant to generate distress during menstruation in the previous 12 months, and the maximum score is "125", indicating the presence of all the investigated symptoms in more than one-half of menstruations in the past year, each of them generating severe distress. Changes in total score at baseline and following 8 week intervention will be noted.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start6 Oct 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysmenorrhea PrimaryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sharjah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zaina Ahmed, University of Sharjah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436507
- Sponsor's protocol ID
- REC-26-02-12-04-PG
- Status last verified
- May 2026
- First submitted
- 21 Feb 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Combined Home-Based Exercise Program on Menstrual Pain, Dual-Task Gait Performance, and Neurophysiological Outcomes in Primary Dysmenorrhoea: A Randomised Controlled Trial Protocol
- ClinicalTrials.gov ID
- NCT07436507
- Acronym / sponsor ID
- REC-26-02-12-04-PG
- Conditions
- Dysmenorrhea Primary
- Keywords
- Dysmenorrhea Primary, Home exercise program, Dual-Task Gait Performance, Cognitive Motor Control
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- University of SharjahUniversity, hospital or other
- Study start
- 6 Oct 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 27 Feb 2026 (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.
What is this study about? Dysmenorrhea, commonly known as painful period, is a common gynecological symptom experienced by several women of reproductive age. This particular type of pain arises during the menstrual cycle, often negatively impacting the quality of life and ability to successfully carry out daily activities and academic or work performance. This is study will involve physiotherapy treatment in the form of a home-based exercise program for those experiencing dysmenorrhea. The purpose of this study is to determine how effective this exercise intervention is by assessing the pain score, menstrual symptoms, gait performance and cognitive-motor control.
Detailed description
What will the participant have to do if they take part? They will be asked to come to the University of Sharjah so the investigators can get some measurements. The participant will be asked to fill a form with the basic information about themselves, including as name, age, occupation, height, weight and contact details. They will also be asked about their menstrual pain score on VAS pain scale and to complete a questionnaire about their menstrual symptoms and lifestyle (such as physical activity, sleep, diet etc.). The physiotherapist will then give them a demonstration of the exercises they need to do during this 8-week program. The participant will be required to follow a video recording of the exercises to complete 3 sessions each week, for about 30 minutes. Necessary follow-up will take place each week. They will be given an exercise diary to keep track of when they do these sessions and for how long. On completion of all sessions after 8 weeks, the assessment previously done will be repeated.
What is the criteria for being selected? They study includes females, aged between 18 and 25, who experience dysmenorrhea.
Possible risks of taking part? There are no risks from this study. All the information will be confidential and when the study is finished, they will be destroyed.
Are there any possible benefits? There is expected benefit of the exercises on decreasing menstrual pain and symptoms.
Does the participant have to take part in this study? No. Participation is completely voluntary. If the participant does not wish to consent, they can refuse. If they wish to take part and then change their mind later, they can withdraw from the study any time.
Will the participant's taking part in this study be kept confidential? All the information taken from the participant will remain confidential and only the results will be used in the data analysis with the supervisor without using their name or address so they will not be recognised. At the end of the study, all personal information will be destroyed.
What will happen to the results of the research study? The participant will be notified about the study results once the study has been completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Home-exercise program |
| Control group | No intervention | –Waitlist control group |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- single
- 18-25 years
- meet the diagnostic criteria for PD as outlined in the Primary Dysmenorrhea Consensus Guidelines - first onset of menstrual pain 6-24 months after menarche, pain lasting 8-72h in a cycle, and the most severe pain on the 1st or 2nd day of menstruation
- having a regular menstrual cycle (28 ± 7 days)
- menstrual pain intensity ≥4 cm on VAS in the previous 6 months
Key exclusion criteria (9 listed)
- history of pelvic surgery
- history and/or findings of secondary dysmenorrhea
- history of mental or physical diseases
- history of joint, motion, muscle, or bone diseases which reduce the abilities to exercise
- being a professional athlete
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-exercise programThe participants will then be given a clear explanation of the exercises to be performed as part of the home-based exercise program. They will be provided with a demonstrations video that will guide each session. Each exercise session will last for 30 minutes, 3/week, for 8 weeks. Participants will perform 10 minutes of progressive muscle relaxation exercise, followed by 10 minutes of core exercises, and finally 10 mintes of stretching exercises. They will required to complete an exercise diary. Exercise progressions will be applied across weeks 3-4 and again at weeks 5-6 and 7-8 (e.g., increased hold durations, repetitions, and resistance band progression for core exercises). | Other | Intervention group |
Primary outcome
Pain intensity
Time frame: Baseline and 8 weeks
Pain intensity is self-reported on the Visual Analogue Scale for Pain (VAS Pain), which is a continuous scale in the form of a 100mm line, marked by "no pain" (score of 0) on one end and "pain as bad as it could be" (score of 100) on the other end. The participant is required to make a perpendicular line on the VAS scale that they feel best represent their pain intensity. Change in the pain intensity at baseline and after 8 weeks of intervention will be noted.
Cortical Silent Period
Time frame: Baseline and 8 weeks
Cortical silent period (CSP) will be assessed using the transcranial magnetic stimulation (TMS) apparatus. Single-pulse TMS will be administered using a figure-of-eight coil positioned over the primary motor cortex. CSP duration (ms) will be measured from the MEP onset to return of voluntary EMG activity following cortical stimulation. The minimal effective stimulation intensity will be used to ensure participant safety. Changes at baseline and after 8 weeks of intervention will be noted.
5 secondary outcomes
Dual-Task Gait Performance
Time frame: Baseline and 8 weeks
Dual-Task Cognitive Performance
Time frame: Baseline and 8 weeks
Electroencephalography (EEG) data
Time frame: Baseline and 8 weeks
Dysmenorrhea impact
Time frame: Baseline and 8 weeks
Menstrual Symptoms and Distress
Time frame: Baseline and 8 weeks
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 17 Sep 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Home-exercise program in people with Dysmenorrhea Primary, run by University of Sharjah.
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 9 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: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Pain intensity (time frame: Baseline and 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2026.