Clinical trial NCT06804473: Effect of Aerobic Exercise on Clinical Symptoms During the Ovarian Cycle
Official title: Effect of Aerobic Exercise on Clinical Symptoms During the Ovarian Cycle
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Primary Dysmenorrhea
Keywords: dysmenorrhea
exercise
pain
aerobic exercise
Lead sponsor: Universidad Francisco de Vitoria
Sponsor class: OTHER
First posted: 2025-02-03
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

Eligible participants will first complete a comprehensive questionnaire. This form will gather key information, including demographic data, medical history, details about their menstrual cycles, and current physical activity levels. The diagnosis of primary dysmenorrhea will be confirmed based on clinical history, including characteristics of the pain, its onset with menstruation, accompanying symptoms, and the absence of indicators of secondary dysmenorrhea (e.g., irregular bleeding or unresponsiveness to NSAIDs).

Participants will be randomized in a 1:1 ratio using a computer-generated sequence, ensuring unbiased group assignment. An independent individual will manage the randomization process, and allocation will be concealed using sealed, opaque envelopes distributed sequentially as participants enroll in the study.

The primary goal is to evaluate whether regular aerobic exercise can reduce the severity of menstrual pain associated with primary dysmenorrhea. Secondary outcomes include assessing changes in quality of life, menstrual symptoms, and overall physical well-being.

Primary dysmenorrhea is commonly treated with medications such as nonsteroidal anti-inflammatory drugs (NSAIDs) or hormonal therapies. However, not all patients achieve relief, and some may prefer non-pharmacological approaches due to side effects or personal preferences. This study aims to explore aerobic exercise as a cost-effective, accessible, and safe alternative or complementary intervention.

The findings from this research may provide valuable insights for women seeking non-drug treatments for menstrual pain. If aerobic exercise proves effective, it could empower women with an evidence-based, proactive strategy to manage their symptoms. Healthcare providers may also gain additional tools to recommend as part of holistic care for patients with primary dysmenorrhea.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: Drug intake
timeFrame: Up to 8 weeks
measure: Quality of life
timeFrame: Up to 8 weeks
measure: Quality of life during menstrual bleeding
timeFrame: Up to 8 weeks
measure: Sleep quality
timeFrame: Up to 8 weeks
measure: Stress, anxiety, and depression
timeFrame: Up to 8 weeks
measure: Adherence to the exercise program
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Itani R, Soubra L, Karout S, Rahme D, Karout L, Khojah HMJ. Primary Dysmenorrhea: Pathophysiology, Diagnosis, and Treatment Updates. Korean J Fam Med. 2022 Mar;43(2):101-108. doi: 10.4082/kjfm.21.0103. Epub 2022 Mar 17.