Effect of Aerobic Exercise on Clinical Symptoms During the Ovarian Cycle

NCT06804473 | Not Yet Recruiting

• 1 other identifier: OVARIANEXERCYCLE
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Primary Dysmenorrhea

Keywords

dysmenorrhea; exercise; pain; aerobic exercise

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 8 weeks

Secondary Outcomes (6)

• 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

Study Arms (2)

Control

NO INTERVENTION

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

EXPERIMENTAL

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)

Procedure: Exercise

Interventions

Exercise 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

Intervention group

Eligibility Criteria

• Age: 18 Years - 26 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Francisco de Vitoria: lead

Related Publications (1)

• 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.

  PMID: 35320895 BACKGROUND

MeSH Terms

Conditions

Dysmenorrhea; Motor Activity; Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Alberto Roldan Ruiz, PhD

CONTACT

+34657608266; alberto.roldan@ufv.es

Study Design

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

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: February 3, 2025
• Study Start: March 1, 2025
• Primary Completion: May 30, 2025
• Study Completion: June 30, 2025
• Last Updated: February 3, 2025

Record last verified: 2025-01