NCT07391930

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
37mo left

Started Feb 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Feb 2026Jun 2029

First Submitted

Initial submission to the registry

January 29, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

February 18, 2026

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

2.3 years

First QC Date

January 29, 2026

Last Update Submit

April 19, 2026

Conditions

Keywords

High- Intensity Interval TrainingQuality of LifeMenstrual HealthTherapeutic Exercise

Outcome Measures

Primary Outcomes (1)

  • Change in Menstrual Pain Intensity

    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 Outcomes (5)

  • Health-Related Quality of Life

    Baseline (Month 0), Post-intervention (Month 3), and Follow-up (Month 6, Month 9)

  • Participant Menstrual Health Experience and Self-Management.

    Weekly during the 12-week intervention period

  • Quality of Sleep

    Baseline (Month 0), Post-intervention (Month 3), and Follow-up (Month 6, Month 9)

  • Levels of Depression, Anxiety, and Stress

    Baseline (Month 0), Post-intervention (Month 3), and Follow-up (Month 6, Month 9).

  • Work Productivity and Activity Impairment

    Baseline (Month 0), Post-intervention (Month 3), and Follow-up (Month 6, Month 9).

Study Arms (2)

High-Intensity Interval Training as Therapeutic Exercise + Menstrual Health Education Workshop

EXPERIMENTAL

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.

Behavioral: Supervised Online HIIT ProgramBehavioral: Menstrual Health Workshop

Menstrual Health Education Workshop

ACTIVE COMPARATOR

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.

Behavioral: Menstrual Health Workshop

Interventions

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.

High-Intensity Interval Training as Therapeutic Exercise + Menstrual Health Education 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

High-Intensity Interval Training as Therapeutic Exercise + Menstrual Health Education WorkshopMenstrual Health Education Workshop

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Alcalá, Facultad de Enfermeria y Fisioterapia

Alcalá de Henares, Madrid, 28801, Spain

RECRUITING

MeSH Terms

Conditions

DysmenorrheaPelvic Pain

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Beatriz Navarro Brazalez, PhD

    Universidad de Alcala

    STUDY DIRECTOR

Central Study Contacts

Esther M Pindado Perez, PhD Student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

January 29, 2026

First Posted

February 6, 2026

Study Start

February 18, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2029

Last Updated

April 21, 2026

Record last verified: 2026-04

Locations