Trials / Not Yet Recruiting
Not Yet RecruitingNCT07391930
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
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- University of Alcala · Academic / Other
- Sex
- Female
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2026-02-01
- Primary completion
- 2028-06-01
- Completion
- 2029-06-01
- First posted
- 2026-02-06
- Last updated
- 2026-02-06
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT07391930. Inclusion in this directory is not an endorsement.