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

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

Overview

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.

Interventions

• Other Home-exercise program
  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

Primary outcome measures

• Pain intensity [Time frame: Baseline and 8 weeks]
• Cortical Silent Period [Time frame: Baseline and 8 weeks]

Secondary outcome measures (5)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07436507 · REC-26-02-12-04-PG

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗