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NCT Number: NCT07391930

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

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.

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Key information

Conditions

Dysmenorrhea Primary Dysmenorrhea Menstrual Pain Menstruation Disturbances Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Alcalá, Facultad de Enfermeria y Fisioterapia

Alcalá de Henares, Madrid, 28801, Spain

Location status: Recruiting

Location contact

Esther M Pindado Perez, PhD Student

CONTACT

[email protected]

+34 689714447

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supervised Online HIIT Program

Behavioral

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.

Menstrual Health Workshop

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Esther M Pindado Perez, PhD Student

CONTACT

[email protected]

+34 689714447

Sponsors and collaborators

Lead sponsor

University of Alcala

Other

Registry information

Official study title

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.

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Feb 6, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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