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.
1 other identifier
interventional
60
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2026
Longer than P75 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
January 29, 2026
CompletedFirst Posted
Study publicly available on registry
February 6, 2026
CompletedStudy Start
First participant enrolled
February 18, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2029
April 21, 2026
April 1, 2026
2.3 years
January 29, 2026
April 19, 2026
Conditions
Keywords
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
EXPERIMENTALParticipants 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.
Menstrual Health Education Workshop
ACTIVE COMPARATORParticipants 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.
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.
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
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Beatriz Navarro Brazalez, PhD
Universidad de Alcala
Central Study Contacts
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