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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.
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.
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.
Age
18 - 40 years
Sex
FEMALE
Healthy Volunteers
No
Universidad de Alcalá, Facultad de Enfermeria y Fisioterapia
Alcalá de Henares, Madrid, Spain
Start Date
February 1, 2026
Primary Completion Date
June 1, 2028
Completion Date
June 1, 2029
Last Updated
February 6, 2026
60
ESTIMATED participants
Supervised Online HIIT Program
BEHAVIORAL
Menstrual Health Workshop
BEHAVIORAL
Lead Sponsor
University of Alcala
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT07241637