Effect of Aerobic Exercise on Clinical Symptoms During the Ovarian Cycle
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 44
- Primary Endpoint
- Pain
Study Overview
Brief Summary
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.
Detailed Description
This study investigates the potential benefits of aerobic exercise as a non-pharmacological intervention for primary dysmenorrhea, a condition that affects many women worldwide. Primary dysmenorrhea is characterized by painful cramps during menstruation without underlying pelvic pathology. It often disrupts daily life, leading to discomfort, reduced quality of life, and missed school or work days.
The study will be conducted in Madrid, Spain, between February 2025 and April 2025, and it involves women diagnosed with primary dysmenorrhea. Participants will be assigned to one of two groups using a randomized and single-blind design:
Experimental Group: Participants in this group will engage in a supervised aerobic exercise program tailored to their fitness level. The exercises will be moderate to high intensity, and they will follow established guidelines for safe and effective physical activity.
Control Group: Participants in this group will continue their usual care practices, such as using over-the-counter pain relievers, without additional interventions.
Study Procedures:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 26 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
- •Menstrual pain intensity ≥ 4 mm on the Visual Analog Scale (VAS).
- •Presence of anxiety or stress.
Exclusion Criteria
- •Pregnancy or breastfeeding within the last 3 months.
- •Amenorrhea.
- •Use of oral contraceptives in the last 3 months.
- •Presence of an intrauterine device (IUD).
- •Regular alcohol consumption.
- •Active smoking.
- •Chronic endocrine, digestive, neurological, or uncontrolled cardiovascular diseases, and/or psychiatric disorders.
- •Any medical diagnosis contraindicating physical exercise.
Arms & Interventions
Control
The participants in the control group will continue with their usual care throughout the cycle without receiving the designed intervention. However, they will be asked to complete the follow-up questionnaires.
Intervention group
Participants in the experimental group will perform moderate-to-high intensity aerobic exercise on a stationary bicycle at the gym of Francisco de Vitoria University. The 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. Each interval will include:
Warm up (5min) Active phase: 5 minutes at 60-75% HRmax, corresponding to a perceived exertion level of 5-7 on the modified Borg scale.
Active recovery phase: 1 minute and 30 seconds at 30-50% HRmax, corresponding to a perceived exertion level of 2-3 on the modified Borg scale.
Before starting the session, participants will complete a 5-minute warm-up on the stationary bicycle, progressively increasing intensity as follows: 3 minutes at 50-60% HRmax, 2 minutes at 60-70% HRmax Cool down (5min)
Intervention: Exercise (Procedure)
Outcomes
Primary Outcomes
Pain
Time Frame: Up to 8 weeks
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(Up to 8 weeks)
- Quality of life(Up to 8 weeks)
- Quality of life during menstrual bleeding(Up to 8 weeks)
- Sleep quality(Up to 8 weeks)
- Stress, anxiety, and depression(Up to 8 weeks)
- Adherence to the exercise program(Up to 8 weeks)
Investigators
Alberto Roldán
PhD
Universidad Francisco de Vitoria