Effect of Aerobic Exercise on Clinical Symptoms During the Ovarian Cycle

NCT ID: NCT06804473

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2025-06-30

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.

Conditions

Primary Dysmenorrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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)

Group Type: EXPERIMENTAL

Exercise

Intervention Type: PROCEDURE

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

Interventions

Exercise

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universidad Francisco de Vitoria

OTHER

Sponsor Role: lead

Responsible Party

Alberto Roldán

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Alberto Roldan Ruiz, PhD

Role: CONTACT

alberto.roldan@ufv.es

+34657608266

References

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.

Reference Type: BACKGROUND

PMID: 35320895 (View on PubMed)

Other Identifiers

OVARIANEXERCYCLE

Identifier Type: -

Identifier Source: org_study_id