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Recruiting NCT07391930

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

No phase Interventional Dysmenorrhea Primary Menstrual Pain Pelvic Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Supervised Online HIIT Program, Menstrual Health Workshop.
Who it may be relevant to
Registry conditions: Dysmenorrhea Primary, Menstrual Pain, Pelvic Pain. Basic parameters: 18 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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.

Overview

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

  • Behavioral Supervised 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.
  • Behavioral Menstrual 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

Primary outcome measures

  • Change in Menstrual Pain Intensity [Time frame: Baseline (Month 0), Post-intervention (Month 3), and Follow-up (Month 6, Month 9)]
Secondary outcome measures (5)
  • Health-Related Quality of Life [Time frame: 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]
  • Quality of Sleep [Time frame: 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).]
  • Work Productivity and Activity Impairment [Time frame: Baseline (Month 0), Post-intervention (Month 3), and Follow-up (Month 6, Month 9).]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Universidad de Alcalá, Facultad de Enfermeria y Fisioterapia — Alcalá de Henares

Identifiers

NCT: NCT07391930 · EPP-2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗