About this trial
This study aims to evaluate the effects of moderate-to-high intensity aerobic exercise on primary dysmenorrhea, a common condition characterized by painful menstrual cramps.
The study will involve women diagnosed with primary dysmenorrhea, who will be randomly assigned to one of two groups:
Experimental Group: Participants will perform a supervised aerobic exercise program tailored to their fitness level.
Control Group: Participants will continue their usual care without any additional interventions.
The study will run from February 2025 to April 2025 in Madrid, Spain. Before starting, all participants will complete a questionnaire to gather information about their demographics, menstrual cycle characteristics, medical history, and physical activity levels. This will help ensure an accurate diagnosis of primary dysmenorrhea and provide baseline data for comparison.
Participants will be randomly assigned to their groups using a computer-generated sequence, with allocation managed confidentially to avoid bias. The study's single-blind design ensures that the evaluators will not know the group assignments.
The goal of this research is to determine whether regular aerobic exercise can serve as an effective, non-pharmacological intervention to reduce the severity of menstrual pain and improve the quality of life for women with primary dysmenorrhea. The findings will inform patients, families, and healthcare providers about potential lifestyle strategies to manage this condition.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 26 years.
Sedentary lifestyle.
Body Mass Index (BMI) between 18.5 and 26 kg/m².
Regular menstrual cycle (24-38 days).
Disqualifiers
Pregnancy or breastfeeding within the last 3 months.
Amenorrhea.
Use of oral contraceptives in the last 3 months.
Presence of an intrauterine device (IUD).
Trial design
Parallel
Treatments tested in this trial
Exercise
Procedure/SurgeryThe exercise intensity will range from 60-75% of their maximum heart rate (HRmax), with each session lasting 28 minutes, three times per week. The exercise protocol will involve interval aerobic training consisting of four intervals
Treatment groups
Trial outcomes
Primary outcomes
Pain
Menstrual pain intensity will be assessed using the Visual Analog Scale (VAS) 24 hours before the onset of menstruation and during menstruation. The scale ranges from 0 to 10, with higher scores indicating greater perceived pain intensity (Guillian, 2011). Participants will be required to complete the scale on menstrual days to evaluate their pain levels.
Secondary outcomes
Drug intake
The use of analgesic medication will be recorded individually throughout the study to gather information on the amount consumed during the two menstruations evaluated during the intervention. This data will be analyzed to determine whether the designed exercise program influences the need for medication use (Armour, 2019).
Quality of life
The participants' quality of life will be assessed using the SF-12 questionnaire, which consists of 12 questions with response options ranging from 3 to 5 points, depending on the question. Higher scores will indicate better health status. The questionnaire evaluates eight dimensions grouped into two main components: the physical component and the mental component (Schmidt, 2012; Ware, 1996).
Quality of life during menstrual bleeding
Quality of life during menstrual bleeding days will be measured using the CVM-22 questionnaire, which comprises 22 questions evaluating the following components: health perception, physical and functional well-being, psychological and cognitive well-being, and menstrual-related symptoms. Higher scores on the CVM-22 indicate a worse quality of life during menstrual bleeding days (Pascual, 2019).
Sleep quality
Sleep quality will be assessed using the Women's Health Initiative Insomnia Rating Scale (WHIIRS), which quantitatively evaluates the severity of insomnia. The scale consists of five questions assessing aspects such as difficulty falling asleep, nighttime awakenings, early morning awakenings, satisfaction with sleep, and daytime fatigue. Each question is scored from 0 (never) to 4 (always), yielding a global score ranging from 0 to 20 points, with a score above 9 indicating clinical relevance (Levine, 2003).
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