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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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07391930
Enrollment
60
Registered
2026-02-06
Start date
2026-02-18
Completion date
2029-06-01
Last updated
2026-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysmenorrhea Primary, Menstrual Pain, Pelvic Pain

Keywords

High- Intensity Interval Training, Quality of Life, Menstrual Health, Therapeutic Exercise

Brief summary

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.

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.

Interventions

BEHAVIORALSupervised Online HIIT Program

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.

BEHAVIORALMenstrual Health Workshop

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

Sponsors

University of Alcala
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Menstrual Pain IntensityBaseline (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

MeasureTime frameDescription
Health-Related Quality of LifeBaseline (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.
Participant Menstrual Health Experience and Self-Management.Weekly during the 12-week intervention periodQualitative 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.
Quality of SleepBaseline (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.
Levels of Depression, Anxiety, and StressBaseline (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.
Work Productivity and Activity ImpairmentBaseline (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.

Countries

Spain

Contacts

CONTACTEsther M Pindado Perez, PhD Student
esther.pindado@edu.uah.es+34 689714447
STUDY_DIRECTORBeatriz Navarro Brazalez, PhD

Universidad de Alcala

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 22, 2026