Primary DysmenorrheaOVARIANEXERCYCNCT06804473
Effect of Aerobic Exercise on Clinical Symptoms During the Ovarian Cycle
A study testing Exercise in people with Primary Dysmenorrhea, run by Universidad Francisco de Vitoria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 26 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 26 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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:
Read more
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.
Read the 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
- Being tested
- Exercise
- Keywords
- dysmenorrhea, exercise, pain, aerobic exercise
- Medical subject headings
- Dysmenorrhea, Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Procedure: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 8 weeks
Secondary outcomes (6)
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).
Measured: Up to 8 weeks
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).
Measured: Up to 8 weeks
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).
Measured: Up to 8 weeks
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).
Measured: Up to 8 weeks
Stress, anxiety, and depression
Stress, anxiety, and depression will be measured using the Depression, Anxiety, and Stress Scale - 21 (DASS-21). This self-report tool includes 21 statements and a 4-point response scale to assess experienced symptoms. Response options include: 0, "does not apply at all"; 1, "applies somewhat or occasionally"; 2, "applies to a considerable degree or often"; and 3, "applies very much or almost always." Higher scores on the DASS-21 indicate greater levels of depression, anxiety, or stress (Fonseca, 2010).
Measured: Up to 8 weeks
Adherence to the exercise program
Adherence to the exercise program at Francisco de Vitoria University will be measured through attendance records for the sessions scheduled individually with each participant.
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion30 May 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Francisco de Vitoria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Roldán, Universidad Francisco de Vitoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804473
- Sponsor's protocol ID
- OVARIANEXERCYCLE
- Acronym
- OVARIANEXERCYC
- Status last verified
- Jan 2025
- First submitted
- 21 Jan 2025
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this time, there are no plans to share individual participant data (IPD). The primary reason for this decision is to protect the confidentiality and privacy of participants, as sharing IPD may pose a risk of re-identification despite anonymization efforts. Additionally, the study does not have a specific framework or infrastructure in place for secure and compliant IPD sharing. However, summary data and results of the study will be disseminated through peer-reviewed publications and presentations at scientific conferences, ensuring that the scientific community and the public can benefit from the findings.
Publications
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.
PubMed 35320895
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aerobic Exercise on Clinical Symptoms During the Ovarian Cycle
- ClinicalTrials.gov ID
- NCT06804473
- Acronym / sponsor ID
- OVARIANEXERCYC / OVARIANEXERCYCLE
- Conditions
- Primary Dysmenorrhea
- Keywords
- dysmenorrhea, exercise, pain, aerobic exercise
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Universidad Francisco de VitoriaUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Procedure: ExerciseParticipants 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) |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseThe 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 | Procedure or surgery | Intervention group |
Primary outcome
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.
6 secondary outcomes
Drug intake
Time frame: Up to 8 weeks
Quality of life
Time frame: Up to 8 weeks
Quality of life during menstrual bleeding
Time frame: Up to 8 weeks
Sleep quality
Time frame: Up to 8 weeks
Stress, anxiety, and depression
Time frame: Up to 8 weeks
Adherence to the exercise program
Time frame: Up to 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Background: PubMed 35320895Itani 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.
- Individual participant dataSharing planned: Undecided. At this time, there are no plans to share individual participant data (IPD). The primary reason for this decision is to protect the confidentiality and privacy of participants, as sharing IPD may pose a risk of re-identification despite anonymization efforts. Additionally, the study does not have a specific framework or infrastructure in place for secure and compliant IPD sharing. However, summary data and results of the study will be disseminated through peer-reviewed publications and presentations at scientific conferences, ensuring that the scientific community and the public can benefit from the findings.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Primary Dysmenorrhea, run by Universidad Francisco de Vitoria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alberto Roldan Ruiz, PhD (+34657608266, alberto.roldan@ufv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: Up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06804473, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.