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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Menstrual Pain Intensity
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
High-Intensity Interval Training as Therapeutic Exercise + Menstrual Health Education Workshop
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.
干预措施: Menstrual Health Workshop (Behavioral)
Menstrual Health Education Workshop
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.
干预措施: Menstrual Health Workshop (Behavioral)
High-Intensity Interval Training as Therapeutic Exercise + Menstrual Health Education Workshop
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.
干预措施: Supervised Online HIIT Program (Behavioral)
结局指标
主要结局
Change in Menstrual Pain Intensity
时间窗: Baseline (Month 0), Post-intervention (Month 3), and Follow-up (Month 6, Month 9)
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.
次要结局
- 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).)
研究者
Esther María Pindado Pérez
PhD Student
University of Alcala