Examining the Impact of Aerobic and Core Exercises on Primary Dysmenorrhea in High School Females

NCT06394726 | Completed

• 1 other identifier: İstanbulBilgiiiU
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Dysmenorrhea, derived from ancient Greek, translates to 'difficult monthly flow' and refers to painful cramps during menstruation, a common cause of pelvic pain. The pain, often in the lower abdomen, results from uterine pressure exceeding 60 mmHg. Symptoms include suprapubic pain, radiating discomfort, nausea, diarrhea, and headache, impacting quality of life. Etiology involves factors like age at menarche, heavy flow, lifestyle, and medical conditions. Dysmenorrhea is categorized as primary (without underlying pathology) or secondary (due to conditions like endometriosis). Its prevalence is high in adolescence, affecting daily life, school, and health. Research aims to assess how aerobic and core exercises influence pain and quality of life in adolescent females (14-18 years). Participants are randomly assigned to study and control groups, exploring the potential benefits for health, well-being, and academic performance.

Conditions

Dysmenorrhea

Keywords

Aerobic exercise; Core Stabilization Exercises

Outcome Measures

Primary Outcomes (2)

• Visual Analog Scale

  VAS is a common tool for assessing subjective experiences like pain or mood intensity. It consists of a 10-centimeter line with clear endpoints representing extreme sensations. Participants mark a point on the line corresponding to their perception, such as "No Pain" to "Worst Pain Imaginable." The distance from "No Pain" provides a quantitative measure. Easy to administer and adaptable, VAS is widely used in clinical and research settings for various subjective states beyond pain, requiring no specialized training. "In this scale, '0' corresponds to the best, and '10' to the worst

  baseline and 12 weeks

• Functional and Emotional functional and emotional measure of dysmenorrhea (FEMD)

  "FEMD" stands for Functional and Emotional Measure of Dysmenorrhea. Dysmenorrhea refers to painful menstruation, commonly known as menstrual cramps. The FEMD is a tool or scale used to assess both the functional and emotional impacts of dysmenorrhea on individuals. The functional aspect of the FEMD typically evaluates the severity of physical symptoms associated with dysmenorrhea, such as the intensity of pain, its duration, any associated symptoms like nausea or vomiting, and how these symptoms affect daily activities or functioning. The scale consists of 14 items and 2 subscales. Each item is scored on a scale from 1 to 5: (1) Not at all like my condition, (2) Not much like my condition, (3) Somewhat like and somewhat unlike my condition, (4) Much like my condition, (5) Very much like my condition. There are no reverse items. As scores increase on this scale, individuals' levels of functional and emotional impact from dysmenorrhea also increase."

  baseline and 12 weeks

Secondary Outcomes (4)

• SF-36 Short Form 36 Health Survey

  baseline and 12 weeks

• A dysmenorrhea monitoring form

  baseline and 12 weeks

• Dysmenorrhea Impact Scale short form

  baseline and 12 weeks

• Menstrual Symptom Questionnaire

  baseline and 12 weeks

Study Arms (2)

Aerobic Exercise Group

ACTIVE COMPARATOR

Aerobic Exercise Group For 3 months, participants will engage in a total of 150 minutes of exercise per week, either 30 minutes for 5 days a week or 50 minutes for 3 days a week.

Behavioral: Exercise İntervention

Core Stabilization Exercise Group

ACTIVE COMPARATOR

Core Stabilization Exercise Group for 3 months, 2 sets of exercises, each comprising 10 repetitions per set.

Behavioral: Exercise İntervention

Interventions

Exercise İntervention BEHAVIORAL

Aerobic and Core Stabilization Exercise Intervention

Aerobic Exercise Group; Core Stabilization Exercise Group

Eligibility Criteria

• Age: 14 Years - 18 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Be nulliparous (have not given birth) and be between the ages of 14-18.
• Volunteer to participate.
• Have no active sexual life.
• Have a regular menstrual cycle.
• Report a pain intensity of 5 or above on the Visual Analog Scale (VAS).
• Have a Body Mass Index (BMI) between 19 and 24.9.
• Not have polycystic ovary syndrome or undergone any surgical operation related to female diseases.
• Not engage in regular exercise.
• Not have any chronic, systemic, neurological, or endocrinological diseases.

You may not qualify if:

• Participate in tele-rehabilitation and exercise diary for less than 3 days.
• Use an intrauterine device.
• Have taken pharmacological supplements in the last 3 months or during the study tracking period (due to reasons such as flu, COVID, etc.).
• Have any physical impediment restricting physical activity.

Sponsors & Collaborators

• Istanbul Bilgi University: lead

Study Sites (1)

Istanbul Bilgi University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Aycan Cakmak Reyhan, PhD

  Istanbul Bilgi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Controlled Study

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: May 1, 2024
• Study Start: March 1, 2024
• Primary Completion: May 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)