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NCT Number: NCT07436507

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

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.

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Key information

Conditions

Dysmenorrhea Primary

Age range

18 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • used an intrauterine device or oral contraceptive pill
  • metal implants, including pacemaker
  • history of non-normal brain activity, including seizures

Treatment and study plan

Home-exercise program

Other

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).

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Dual-Task Gait Performance

    Time frame: Baseline and 8 weeks

    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.

  2. Dual-Task Cognitive Performance

    Time frame: Baseline and 8 weeks

    Cognitive Performance on three tasks (logistic, semantic verbal fluency and working memory) will assessed during walking, at baseline and after 8 weeks intervention.

  3. Electroencephalography (EEG) data

    Time frame: Baseline and 8 weeks

    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.

  4. Dysmenorrhea impact

    Time frame: Baseline and 8 weeks

    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.

  5. Menstrual Symptoms and Distress

    Time frame: Baseline and 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Sharjah

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 27, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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