- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07391930
High-Intensity Interval Training and Menstrual Health Experience in Primary Dysmenorrhea.
Efficacy of a High-Intensity Interval Training Program and Analysis of Menstrual Health Experience in Women With Primary Dysmenorrhea: A Mixed-Methods Randomized Controlled Trial.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This research follows a convergent mixed-methods design integrating a randomized controlled trial with a descriptive qualitative study.
Fifty women (aged 18-40) with primary dysmenorrhea will be randomized into two arms:
Experimental Group: 12 weeks of online supervised HIIT (2 sessions/week) plus a menstrual health educational workshop.
Control Group: Menstrual health educational workshop only. Clinical variables (pain intensity via NRS, quality of life via SF-12, and pain characteristics via McGill Questionnaire) will be collected at baseline, 3 months (post-intervention), and 6 months (follow-up).
Simultaneously, all participants will complete a weekly semi-structured digital diary for 12 weeks. These diaries are designed to capture the "thick description" of their menstrual health experience, focusing on the evolution of their relationship with their body and menstruation, perceptions of self-management and empowerment and barriers and facilitators for adherence to the exercise program (in the experimental group).
Following the convergent design, quantitative statistical results will be integrated with the thematic analysis of the diaries. This merging of data will provide a holistic understanding of how high-intensity exercise influences not only physical symptoms but also the biopsychosocial perception of menstrual health in young women.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Esther M Pindado Perez, PhD Student
- Phone Number: +34 689714447
- Email: esther.pindado@edu.uah.es
Study Locations
-
-
Madrid
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Alcalá de Henares, Madrid, Spain, 28801
- Recruiting
- Universidad de Alcalá, Facultad de Enfermeria y Fisioterapia
-
Contact:
- Esther M Pindado Perez, PhD Student
- Phone Number: +34 689714447
- Email: esther.pindado@edu.uah.es
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- nulliparous
- primary dysmenorrhea
- body mass index between 18 and 30
- menstrual pain >5 according to the Numeric Pain Scale
- exercise >45 minutes/week
- understand Spanish and can freely read and sign the informed consent form
Exclusion Criteria:
- amenorrhea or cycles >35 days
- secondary dysmenorrhea
- pelvic or abdominal surgical intervention
- use of hormonal drugs
- diagnosed with fibromyalgia, muscoloskeletal injuries or medical comorbidities that prevent them from performing intense exercise
- receiving physiotherapy for pelvic floor disorders
- intense exercise >75 minutes/week
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High-Intensity Interval Training as Therapeutic Exercise + Menstrual Health Education Workshop
Participants in this arm will receive a 2-hour online menstrual health education workshop and will perform 2 sessions per week of supervised online High-Intensity Interval Training (HIIT) for 12 weeks.
They will also complete weekly qualitative diaries.
|
The intervention consists of a total of 24 exercise sessions delivered over 12 weeks (frequency: 2 sessions per week).
Each session is conducted online and supervised in real-time by a physical therapist.
The 24 sessions follow a structured progression of high-intensity intervals, separated by active recovery periods.
A 2-hour online educational session covering menstrual cycle physiology, pain neurophysiology, and self-care strategies.
This intervention aims to improve menstrual health literacy and provide tools for pain self-management
|
|
Active Comparator: Menstrual Health Education Workshop
Participants in this arm will receive the same 2-hour online menstrual health education workshop and will complete the same weekly qualitative diaries, but will not perform the HIIT program during the 12-week study period.
|
A 2-hour online educational session covering menstrual cycle physiology, pain neurophysiology, and self-care strategies.
This intervention aims to improve menstrual health literacy and provide tools for pain self-management
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Menstrual Pain Intensity
Time Frame: Baseline (Month 0), Post-intervention (Month 3), and Follow-up (Month 6, Month 9)
|
Measured using the Numeric Rating Scale (NRS), where 0 represents "no pain" and 10 represents "the worst pain imaginable."
Participants will report their peak pain intensity during their menstrual period.
|
Baseline (Month 0), Post-intervention (Month 3), and Follow-up (Month 6, Month 9)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health-Related Quality of Life
Time Frame: Baseline (Month 0), Post-intervention (Month 3), and Follow-up (Month 6, Month 9)
|
Assessed using the Short Form-12 (SF-12) Health Survey, which measures physical and mental health components.
Higher scores indicate better quality of life.
|
Baseline (Month 0), Post-intervention (Month 3), and Follow-up (Month 6, Month 9)
|
|
Participant Menstrual Health Experience and Self-Management.
Time Frame: Weekly during the 12-week intervention period
|
Qualitative assessment through the thematic analysis of weekly semi-structured digital diaries.
This measure explores the evolution of the participants' relationship with their bodies, the practical application of self-care strategies, and the subjective perception of the intervention's impact.
Data will be analyzed using a phenomenological approach to identify emerging themes.
|
Weekly during the 12-week intervention period
|
|
Quality of Sleep
Time Frame: Baseline (Month 0), Post-intervention (Month 3), and Follow-up (Month 6, Month 9)
|
Assessed using the Pittsburgh Sleep Quality Index (PSQI).
It measures seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction.
Scores range from 0 to 21, where higher scores indicate poorer sleep quality.
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Baseline (Month 0), Post-intervention (Month 3), and Follow-up (Month 6, Month 9)
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|
Levels of Depression, Anxiety, and Stress
Time Frame: Baseline (Month 0), Post-intervention (Month 3), and Follow-up (Month 6, Month 9).
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Measured using the Depression, Anxiety, and Stress Scale (DASS-21).
This 21-item scale provides independent scores for each of the three psychological states.
Higher scores reflect higher levels of distress.
|
Baseline (Month 0), Post-intervention (Month 3), and Follow-up (Month 6, Month 9).
|
|
Work Productivity and Activity Impairment
Time Frame: Baseline (Month 0), Post-intervention (Month 3), and Follow-up (Month 6, Month 9).
|
Measured using the Work Productivity and Activity Impairment (WPAI) questionnaire.
It evaluates the impact of menstrual pain on work absenteeism, presenteeism, and daily activity impairment.
Results are expressed as percentages of impairment.
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Baseline (Month 0), Post-intervention (Month 3), and Follow-up (Month 6, Month 9).
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Beatriz Navarro Brazalez, PhD, Universidad de Alcala
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EPP-2026
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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