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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-25
SponsorUniversity of Sharjah

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Home-exercise program

    Other intervention

    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).

Treatment groups

86 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and 8 weeks
2

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.

Time frame
Baseline and 8 weeks

Secondary outcomes

1

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.

Time frame
Baseline and 8 weeks
2

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.

Time frame
Baseline and 8 weeks
3

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.

Time frame
Baseline and 8 weeks
4

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.

Time frame
Baseline and 8 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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