High-Intensity Interval Training and Menstrual Health Experience in Primary Dysmenorrhea.

April 19, 2026 updated by: Esther María Pindado Pérez, University of Alcala

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.

The goal of this study is to evaluate whether a 12-week online supervised high-intensity interval training program can reduce menstrual pain and improve quality of life in women with primary dysmenorrhea. Participants will be divided into two groups: one receiving an educational workshop and the HIIT program, and a control group receiving only the workshop. Additionally, the study seeks to understand the personal experience of these women through weekly health diaries, exploring how the intervention affects their relationship with their bodies and their menstruation. The ultimate goal is to offer new, non-pharmacological evidence-based tools for managing menstrual pain.

Study Overview

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

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Madrid
      • Alcalá de Henares, Madrid, Spain, 28801
        • Recruiting
        • Universidad de Alcalá, Facultad de Enfermeria y Fisioterapia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Baseline (Month 0), Post-intervention (Month 3), and Follow-up (Month 6, Month 9)
Levels of Depression, Anxiety, and Stress
Time Frame: Baseline (Month 0), Post-intervention (Month 3), and Follow-up (Month 6, Month 9).
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.
Baseline (Month 0), Post-intervention (Month 3), and Follow-up (Month 6, Month 9).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Beatriz Navarro Brazalez, PhD, Universidad de Alcala

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

January 29, 2026

First Submitted That Met QC Criteria

January 29, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 19, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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